xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06000280</url>
    </required_header>
    <id_info>
      <org_study_id>CEROF</org_study_id>
      <nct_id>NCT06000280</nct_id>
    </id_info>
    <brief_title>Evaluation of Retina in Patients With Glaucoma Using Topical Prostaglandins Undergoing Trabeculectomy Surgery</brief_title>
    <acronym>TRAB</acronym>
    <official_title>Evaluation of Macular Thickness in Patients With Glaucoma in Use of Topical Prostaglandin Analogue Undergoing Trabeculectomy With Mitomycin C</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidade Federal de Goias</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universidade Federal de Goias</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study was to verify whether prostaglandin analogue (PA) eye drops influence&#xD;
        the retinal thickness of glaucomatous patients undergoing trabeculectomy (TRAB) surgery. We&#xD;
        selected eyes of patients with glaucoma with surgical indication for TRAB who were using PA&#xD;
        eye drops and without previous retinal alterations, from the Centro de Referência em&#xD;
        Oftalmologia (CEROF) from the Federal University of Goiás and Fundação Banco de Olhos de&#xD;
        Goiás (FUBOG). Patients were divided into 2 groups: the study group (SG) and the control&#xD;
        group (CG). In the CG, the PA was suspended between 30 and 60 days before the preoperative&#xD;
        exams were performed (maximum of 15 days before surgery for both groups). All patients&#xD;
        included were submitted to various eye exams before the procedure, and postoperatively on 3&#xD;
        occasions: 1 to 3 days (&quot;PO1&quot;), 6 to 9 days (&quot;PO7&quot;) and 27 to 30 days (&quot;PO30&quot;) after surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Purpose: The aim of this study was to verify whether topical prostaglandin analogue (PA)&#xD;
        influence the macular thickness of glaucomatous patients undergoing trabeculectomy (TRAB)&#xD;
        with Mitomycin C (MMC) .&#xD;
  &#xD;
        Design:This is a randomized, prospective, comparative clinical trial with a single surgeon&#xD;
        and masked to the study group.&#xD;
  &#xD;
        Methods: We prospectively selected 40 eyes of patients with glaucoma with surgical indication&#xD;
        for TRAB with MMC (0.4 mg/ml for 2 min) who were using prostaglandin analogue (PA) eye drops&#xD;
        and without previous macular alterations, from the Centro de Referência em Oftalmologia&#xD;
        (CEROF) from the Federal University of Goiás and Fundação Banco de Olhos de Goiás (FUBOG).&#xD;
        The research had as inclusion criteria: patients with at least 18 years of age with Primary&#xD;
        Glaucoma (Primary Open Angle Glaucoma, Primary Closed Angle Glaucoma, Normal Pressure&#xD;
        Glaucoma, Pigmentary Glaucoma, Pseudoesfoliative Glaucoma), with changes in the visual field,&#xD;
        typical defect compatible with glaucomatous lesion and/or typical anatomical impairment of&#xD;
        the optic disc or retinal nerve fiber layer (such as Hoyt's sign, optic disc cupping ratio&#xD;
        greater than 0.7, localized defect in the neural rima, or cupping asymmetry), who had an&#xD;
        indication for TRAB with MMC at the physician's discretion (target IOP not established with&#xD;
        maximum tolerable clinical medication and/or impossibility of using medication due to&#xD;
        allergies and/or financial conditions). To be included, the operated eyes needed a reduction&#xD;
        in IOP of at least 20% in relation to the baseline IOP in the last postoperative period (PO&#xD;
        30), and absence of the use of any ocular hypotensive medication. Exclusion criteria were any&#xD;
        pathology that could interfere with the test results, such as: cataracts, corneal edema (such&#xD;
        as leucoma, ulcers, keratopathies); poor quality of the OCT scan (signal strength ≤ 5/10);&#xD;
        any past macular pathology (such as macular hole, diabetic maculopathy, age-related macular&#xD;
        disease); use of diamox; advanced glaucoma with maximal therapy; advanced glaucoma with&#xD;
        impaired fixation; any surgical complications including hypotonia (IOP &lt; 6 mmHg) at any&#xD;
        assessment; performing combined cataract and glaucoma surgery; history of cataract surgery&#xD;
        less than 6 months ago; need for surgical reintervention during follow-up for any reason; and&#xD;
        need for reintroduction of topical antiglaucoma therapy during follow-up. Eligible volunteers&#xD;
        were previously randomized through the website www.randomization.com into 2 groups: study&#xD;
        group (SG) and control group (CG). The initial objective was to include 40 eyes, 20 per&#xD;
        group.&#xD;
  &#xD;
        In the SG, patients were instructed to keep using eyedrops (including PA) until the day of&#xD;
        surgery. In the CG, patients were instructed to suspend the PA between 30-60 days after the&#xD;
        preoperative exams were performed, which were performed a maximum of 15 days before surgery&#xD;
        for both groups. In the CG, patients were instructed to use 01 drop of carmellose sodium&#xD;
        5mg/ml at the same time they used the AP before its suspension. Pseudophakic patients for&#xD;
        more than six months were included in each group in the order of previous randomization. In&#xD;
        the CG, patients were informed to keep the eye drops in use, and to add the other classes of&#xD;
        ocular hypotensive drugs, if they were not using them (except miotics and oral&#xD;
        acetazolamide), with the aim of at least remedying the loss of the ocular hypotensive effect&#xD;
        of the PA. The individuals were evaluated, including best corrected visual acuity by the&#xD;
        Snellen chart, slit lamp biomicroscopy (XCELL 255, Reichert Inc., Depew, NY, USA),&#xD;
        intraocular pressure (IOP) measured in a calibrated Goldmann tonometer (CT210, Reichert Inc.&#xD;
        , Depew, NY, USA), gonioscopy with a 4-mirror Goldman lens (Volk Optical Inc, Mentor, OH,&#xD;
        USA), fundoscopy under mydriasis with a 78D lens (Volk Optical Inc, Mentor, OH, USA),&#xD;
        indirect binocular ophthalmoscopy with 2.0D lens (Volk Optical Inc, Mentor, OH, USA) and&#xD;
        Optical Coherence Tomography (OCT) with Cirrus 4000 (Zeiss Inc.), macular protocol (macular&#xD;
        thickness and ganglion cell analysis) preoperatively ( maximum of 15 days before surgery),&#xD;
        and postoperatively on 3 occasions: 1 to 3 days (&quot;PO1&quot;), 6 to 9 days (&quot;PO7&quot;) and 27 to 30&#xD;
        days (&quot;PO30&quot;). All tests were performed by the same technician, who was trained and&#xD;
        experienced to carry them out. All patients underwent visual field examinations (Humphrey&#xD;
        Field, model HFA II ÿ750, Carl Zeiss-Meditec, Dublin, California, USA) prior to surgery with&#xD;
        the Swedish Interactive Threshold Algorithm (SITA) Standard 24-2 strategy, at most up to 2&#xD;
        months before the procedure. Macular thickness was evaluated by spectral domain Optical&#xD;
        Coherence Tomography (OCT) obtained using the Cirrus 4000 apparatus (Zeiss Inc.), macular&#xD;
        scanning protocol (macular thickness and ganglion cell analysis). Calculations were made&#xD;
        based on data from the Ganglion cell analytical program and Macular Thickness: Macular cube&#xD;
        (6 x 6 mm - 512 A-scans x 128 B-scans centered on the fovea). The macular thickness map using&#xD;
        the 1mm, 3mm, and 6mm circles from the Early Treatment Diabetic Retinopathy Study (ETDRS) was&#xD;
        used to assess the thickness of the 9 subfields. The regions were designated as: parafoveal&#xD;
        (subfields of the 3 mm rings) and perifoveal (subfields of the 6 mm rings) superior,&#xD;
        inferior, temporal and nasal in addition to the central subfield. OCT images were excluded if&#xD;
        the signal strength was ≤5/10, and a new scan was immediately performed. Trabeculectomy using&#xD;
        mitomycin C consisted of opening the conjunctival base of the fornix and applying mitomycin C&#xD;
        0.4 mg/ml for 2 minutes, as previously described. The postoperative regimen in both groups&#xD;
        included the use of 1% Prednisolone eye drops (Ster® União Química Farmacêutica Nacional&#xD;
        S/A., Pouso Alegre, MG, Brazil) starting every 2 hours, with a weekly reduction for 6 weeks (&#xD;
        4/4 h, followed by 6/6 h, then every 8 h, 12/12 h and once a day), Moxifloxacin eye drops&#xD;
        (Vigamox®, AlconLabs, Fort Worth, TX, USA) every 6 h for 10 days.&#xD;
  &#xD;
        Statistical analysis was performed using the Statistical Package for Social Sciences program&#xD;
        (IBM Corporation, Armonk, USA) version 26.0. The characterization of the sample was performed&#xD;
        using absolute frequency, relative frequency, mean, standard deviation, median, minimum and&#xD;
        maximum. Student's t test and Pearson's chi-square test were applied to the distribution of&#xD;
        profile and macular parameters in groups with and without prostaglandin. Data normality was&#xD;
        verified using the Shapiro-Wilk test. The delta and percentage variation were calculated at&#xD;
        PO1, PO7 and PO30 in relation to the preoperative period. Correlation analysis was performed&#xD;
        between thickness deltas with visual field Mean Deviation (MD) and IOP in groups with and&#xD;
        without prostaglandin, weighted the effect of lens classification (partial correlation). The&#xD;
        significance level adopted was 5% (p &lt; 0.05).&#xD;
  &#xD;
        Initially, 40 eyes were randomly assigned to the study, of which 17 were excluded because&#xD;
        they did not meet the eligibility criteria for the study postoperatively. Among these, 4&#xD;
        patients did not undergo OCT at PO1, 4 patients did not undergo OCT at PO7, 2 patients did&#xD;
        not undergo OCT at PO30, 1 patient had a signal ≤ 5/10 of OCT at all visits, even with&#xD;
        several repetitions of the examinations, 3 patients underwent surgical reintervention during&#xD;
        follow-up (suture dehiscence), 2 patients had hypotonia, finally 1 patient did not present&#xD;
        IOP reduction by at least 20% of baseline. Thus, as there was a significant reduction in the&#xD;
        number of patients initially estimated for the sample, a new randomization was performed,&#xD;
        using the same initial randomization process described above to achieve this objective. In&#xD;
        the end, the evaluated sample consisted of 40 eyes from 37 patients, 20 eyes per group (20&#xD;
        eyes from 18 patients in the CG and 20 eyes from 19 patients in the SG).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 4, 2021</start_date>
    <completion_date type="Actual">March 31, 2023</completion_date>
    <primary_completion_date type="Actual">February 28, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>This is a randomized, prospective and comparative clinical trial. Both the surgeon (the only one) and the technician responsible for the exams were blinded to the study groups. The patients (one or both eyes) included were from the glaucoma outpatient clinic of the Fundação Banco de Olhos de Goiás (FUBOG) or the Reference Center in Ophthalmology (CEROF) of the Federal University of Goiás (UFG) between the years 202 and 2022. All patients with glaucoma with indication for Trab with MMC and in clinical use of any PA eye drops (latanoprost, travoprost, bimatoprost or tafluprost) in the eye to be operated on for at least 6 months were considered for inclusion.&#xD;
  The study adhered to the principles of the Declaration of Helsinki and was authorized by the Research Ethics Committee of the UFG, under the Certificate of Presentation for Ethical Appreciation NUMBER 40055620.8.1001.5083. All those included voluntarily agreed to participate by signing the Free and Informed Consent Form.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>The techinician who performed the exams (Optical Coherence Tomography and Visual Field)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Previous use of prostaglandins does not change macular thickness after trabeculectomy</measure>
      <time_frame>Measurements were performed at preop (up to 15 days before the intervention), 1 to 3 days (&quot;PO1&quot;), 6 to 9 days (&quot;PO7&quot;) and 27 to 30 days (&quot;PO30&quot;) after surgery.</time_frame>
      <description>The absolute variation of each variable of the macular parameters OCT in relation to the pre-op was performed and its comparison between the groups at different moments. There was equivalence in most of the evaluated comparisons. Considering the variation between pre-op and PO30, only the upper parafoveal thickness was statistically different between groups (p= 0.01). Taking into account the difference in percentage analyzing pre-op vs. PO30, only the superior parafoveal thickness showed statistical significance between groups (p=0.01).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The presence of the lens did not influence the correlations</measure>
      <time_frame>Measurements were performed at preop (up to 15 days before the intervention) and 27 to 30 days (&quot;PO30&quot;) after surgery.</time_frame>
      <description>Correlations were performed between the deltas of the thicknesses of the macular parameters between the preoperative period and the PO30 within the groups with the possible confounding factors (MD and IOP) and also controlling the intensity of the lens effect (partial correlation). There was no significant correlation in the other tests performed, as well as in relation to the possible influence of the crystalline lens in each of them.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">37</enrollment>
    <condition>Glaucoma</condition>
    <arm_group>
      <arm_group_label>Study group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The Study group refers to patients who are using topical prostaglandins analogues</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The Control group refers to patients who discontinued the use of topical prostaglandins analogues</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Trabeculectomy surgery</intervention_name>
      <description>The Trabeculectomy aims to create a permanent drainage outflow channel for the aqueous humor, connecting the anterior chamber to the sub-Tenon's space, using mitomycin C consisted of opening the conjunctival base of the fornix and applying mitomycin C 0.4 mg/ml for 2 minutes. The trabeculectomy techniques require controlled outflow of aqueous humor through a sclerostomy and a partial-thickness scleral flap to form a subconjunctival bleb. The protected strength of the flap, with or without sutures, and the strength of the episcleral tissue determine the final IOP.</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Study group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinical Diagnose's of Primary Glaucoma&#xD;
  &#xD;
                 -  Primary Open Angle Glaucoma&#xD;
  &#xD;
                 -  Primary Closed Angle Glaucoma&#xD;
  &#xD;
                 -  Normal Pressure Glaucoma&#xD;
  &#xD;
                 -  Pigmentary Glaucoma&#xD;
  &#xD;
                 -  Pseudosfoliative Glaucoma)&#xD;
  &#xD;
            -  Changes in the visual field&#xD;
  &#xD;
            -  Typical defect compatible with glaucomatous lesion and/or typical anatomical&#xD;
               impairment of the optic disc or retinal nerve fiber layer&#xD;
  &#xD;
                 -  Hoyt's sign&#xD;
  &#xD;
                 -  Optic disc cupping ratio greater than 0.7&#xD;
  &#xD;
                 -  Defect located in the neural rim or cupping asymmetry&#xD;
  &#xD;
            -  Indication for TRAB with MMC at the physician's discretion (target IOP not established&#xD;
               with maximum tolerable clinical medication or impossibility of using medication due to&#xD;
               allergies and/or financial conditions)&#xD;
  &#xD;
            -  The operated eyes needed a reduction in IOP by at least 20% in relation to the&#xD;
               baseline IOP in the last postoperative period (PO30)&#xD;
  &#xD;
            -  Absence of the use of any ocular hypotensive medication.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any pathology that could interfere with the test results&#xD;
  &#xD;
                 -  cataract (crystalline opacity)&#xD;
  &#xD;
                 -  corneal edema (such as leucoma, ulcers, keratopathies)&#xD;
  &#xD;
                 -  poor quality of exams (≤ 5/10)&#xD;
  &#xD;
                 -  any past macular pathology (such as macular hole, diabetic maculopathy, age&#xD;
                    related macular disease);&#xD;
  &#xD;
            -  Use of diamox&#xD;
  &#xD;
            -  Advanced glaucoma with maximal therapy&#xD;
  &#xD;
            -  Advanced glaucoma with impaired fixation&#xD;
  &#xD;
            -  Any surgical complications including hypotonia (IOP &lt; 6 mmHg) at any assessment&#xD;
  &#xD;
            -  Performing combined cataract and glaucoma surgery&#xD;
  &#xD;
            -  History of cataract surgery less than 6 months ago&#xD;
  &#xD;
            -  Need for surgical reintervention during follow-up for any reason&#xD;
  &#xD;
            -  Need for reintroduction of topical antiglaucoma therapy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Individuals self-identified as male and female were eligible for the study.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Leopoldo Magacho dos Santos Silva, Doctor</last_name>
      <role>Study Director</role>
      <affiliation>Universidade Federal de Goias</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Centro de Referencia em Oftalmologia</name>
        <address>
          <city>Goiânia</city>
          <state>Goias</state>
          <zip>74605-020</zip>
          <country>Brazil</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <link>
      <url>https://cerof.ufg.br</url>
      <description>Centro de Referencia em Oftalmologia</description>
    </link>
    <reference>
      <citation>Motero Carrasco J. [A comparative study of the efficacy of lisinopril versus quinapril in controlling light to moderate arterial hypertension. A follow-up with ABPM]. Rev Esp Cardiol. 1995 Nov;48(11):746-53. Spanish.</citation>
      <PMID>8532944</PMID>
    </reference>
    <reference>
      <citation>Yonekawa Y, Kim IK. Pseudophakic cystoid macular edema. Curr Opin Ophthalmol. 2012 Jan;23(1):26-32. doi: 10.1097/ICU.0b013e32834cd5f8.</citation>
      <PMID>22134362</PMID>
    </reference>
    <reference>
      <citation>Vessani R, Frota T, Shigetomi G, Correa P, Mariottoni EB, Tavares I. Structural Changes in the Optic Disc and Macula Detected by Swept-Source Optical Coherence Tomography After Surgical Intraocular Pressure Reduction in Patients with Open-Angle Glaucoma. Clin Ophthalmol. 2021 Jul 14;15:3017-3026. doi: 10.2147/OPTH.S317190. eCollection 2021.</citation>
      <PMID>34285468</PMID>
    </reference>
    <reference>
      <citation>Francoz M, Fenolland JR, Giraud JM, El Chehab H, Sendon D, May F, Renard JP. Reproducibility of macular ganglion cell-inner plexiform layer thickness measurement with cirrus HD-OCT in normal, hypertensive and glaucomatous eyes. Br J Ophthalmol. 2014 Mar;98(3):322-8. doi: 10.1136/bjophthalmol-2012-302242. Epub 2013 Dec 4.</citation>
      <PMID>24307717</PMID>
    </reference>
    <reference>
      <citation>Lavinsky F, Wu M, Schuman JS, Lucy KA, Liu M, Song Y, Fallon J, de Los Angeles Ramos Cadena M, Ishikawa H, Wollstein G. Can Macula and Optic Nerve Head Parameters Detect Glaucoma Progression in Eyes with Advanced Circumpapillary Retinal Nerve Fiber Layer Damage? Ophthalmology. 2018 Dec;125(12):1907-1912. doi: 10.1016/j.ophtha.2018.05.020. Epub 2018 Jun 19.</citation>
      <PMID>29934267</PMID>
    </reference>
    <reference>
      <citation>Klink T, Lieb WE, Gobel W. [Early and late findings with optical coherence tomography (OCT) in patients with postoperative hypotonia]. Ophthalmologe. 2000 May;97(5):353-8. doi: 10.1007/s003470050536. German.</citation>
      <PMID>10892280</PMID>
    </reference>
    <reference>
      <citation>Kim WJ, Kim KN, Sung JY, Kim JY, Kim CS. Relationship between preoperative high intraocular pressure and retinal nerve fibre layer thinning after glaucoma surgery. Sci Rep. 2019 Sep 25;9(1):13901. doi: 10.1038/s41598-019-50406-7.</citation>
      <PMID>31554879</PMID>
    </reference>
    <reference>
      <citation>Kadziauskiene A, Strelkauskaite E, Mockeviciute E, Asoklis R, Lesinskas E, Schmetterer L. Changes in macular thickness after trabeculectomy with or without adjunctive 5-fluorouracil. Acta Med Litu. 2017;24(2):93-100. doi: 10.6001/actamedica.v24i2.3489.</citation>
      <PMID>28845126</PMID>
    </reference>
    <reference>
      <citation>Raghu N, Pandav SS, Kaushik S, Ichhpujani P, Gupta A. Effect of trabeculectomy on RNFL thickness and optic disc parameters using optical coherence tomography. Eye (Lond). 2012 Aug;26(8):1131-7. doi: 10.1038/eye.2012.115. Epub 2012 Jun 22.</citation>
      <PMID>22722487</PMID>
    </reference>
    <reference>
      <citation>Silva D, Lopes AS, Henriques S, Lisboa M, Pinto S, Trancoso Vaz F, Prieto I. Changes in choroidal thickness following trabeculectomy and its correlation with the decline in intraocular pressure. Int Ophthalmol. 2019 May;39(5):1097-1104. doi: 10.1007/s10792-018-0918-y. Epub 2018 Apr 16.</citation>
      <PMID>29663109</PMID>
    </reference>
    <reference>
      <citation>Diaconita V, Quinn M, Jamal D, Dishan B, Malvankar-Mehta MS, Hutnik C. Washout Duration of Prostaglandin Analogues: A Systematic Review and Meta-analysis. J Ophthalmol. 2018 Sep 27;2018:3190684. doi: 10.1155/2018/3190684. eCollection 2018.</citation>
      <PMID>30363694</PMID>
    </reference>
    <reference>
      <citation>Mishima H, Masuda K, Miyake K. The putative role of prostaglandins in cystoid macular edema. Prog Clin Biol Res. 1989;312:251-64. No abstract available.</citation>
      <PMID>2678143</PMID>
    </reference>
    <reference>
      <citation>Taheri PA, Karamanoukian H, Gibbons K, Waldman N, Doerr RJ, Hoover EL. Can patients with minor head injuries be safely discharged home? Arch Surg. 1993 Mar;128(3):289-92. doi: 10.1001/archsurg.1993.01420150043008.</citation>
      <PMID>8442684</PMID>
    </reference>
    <reference>
      <citation>Gupta P, Sidhartha E, Tham YC, Chua DK, Liao J, Cheng CY, Aung T, Wong TY, Cheung CY. Determinants of macular thickness using spectral domain optical coherence tomography in healthy eyes: the Singapore Chinese Eye study. Invest Ophthalmol Vis Sci. 2013 Dec 5;54(13):7968-76. doi: 10.1167/iovs.13-12436.</citation>
      <PMID>24222307</PMID>
    </reference>
    <reference>
      <citation>Lichter PR. Variability of expert observers in evaluating the optic disc. Trans Am Ophthalmol Soc. 1976;74:532-72.</citation>
      <PMID>867638</PMID>
    </reference>
    <reference>
      <citation>Manabe K, Matsuoka Y, Tanito M. Incidence of macular edema development after filtration surgery. Graefes Arch Clin Exp Ophthalmol. 2020 Jun;258(6):1343-1345. doi: 10.1007/s00417-020-04624-9. Epub 2020 Feb 13. No abstract available.</citation>
      <PMID>32055953</PMID>
    </reference>
    <reference>
      <citation>Belyea DA, Dan JA, Lieberman MF, Stamper RL. Midterm follow-up results of combined phacoemulsification, lens implantation, and mitomycin-C trabeculectomy procedure. J Glaucoma. 1997 Apr;6(2):90-8.</citation>
      <PMID>9098816</PMID>
    </reference>
    <reference>
      <citation>Sesar A, Cavar I, Sesar AP, Geber MZ, Sesar I, Laus KN, Vatavuk Z, Mandic Z. Macular thickness after glaucoma filtration surgery. Coll Antropol. 2013 Sep;37(3):841-5.</citation>
      <PMID>24308226</PMID>
    </reference>
    <reference>
      <citation>Karasheva G, Goebel W, Klink T, Haigis W, Grehn F. Changes in macular thickness and depth of anterior chamber in patients after filtration surgery. Graefes Arch Clin Exp Ophthalmol. 2003 Mar;241(3):170-5. doi: 10.1007/s00417-003-0628-6. Epub 2003 Feb 20.</citation>
      <PMID>12644938</PMID>
    </reference>
    <reference>
      <citation>Pitale PM, Chatha U, Patel V, Gupta L, Waisbourd M, Pro MJ. Changes in macular thickness following glaucoma surgery. Int J Ophthalmol. 2016 Aug 18;9(8):1236-7. doi: 10.18240/ijo.2016.08.24. eCollection 2016. No abstract available.</citation>
      <PMID>27588282</PMID>
    </reference>
    <reference>
      <citation>Demirtas AA, Karahan M, Erdem S, Aslan Kaya A, Keklikci U. Long-term effects of trabeculectomy in primary open-angle glaucoma on segmented macular ganglion cell complex alterations. Int Ophthalmol. 2021 Jun;41(6):2249-2263. doi: 10.1007/s10792-021-01840-y. Epub 2021 Apr 21.</citation>
      <PMID>33880684</PMID>
    </reference>
    <reference>
      <citation>Nilforushan N, Loni S, Abdolalizadeh P, Miraftabi A, Banifatemi M, Rakhshan R, Jafari S, Abolfathzadeh N. Early Macular Thickness Changes after Trabeculectomy and Combined Phaco-Trabeculectomy. J Curr Ophthalmol. 2022 Jul 26;34(2):160-166. doi: 10.4103/joco.joco_333_21. eCollection 2022 Apr-Jun.</citation>
      <PMID>36147280</PMID>
    </reference>
    <reference>
      <citation>Wagner FM, Schuster AK, Kianusch K, Stingl J, Pfeiffer N, Hoffmann EM. Long-term success after trabeculectomy in open-angle glaucoma: results of a retrospective cohort study. BMJ Open. 2023 Feb 3;13(2):e068403. doi: 10.1136/bmjopen-2022-068403.</citation>
      <PMID>36737088</PMID>
    </reference>
    <reference>
      <citation>Koike KJ, Chang PT. Trabeculectomy: A Brief History and Review of Current Trends. Int Ophthalmol Clin. 2018 Summer;58(3):117-133. doi: 10.1097/IIO.0000000000000231. No abstract available.</citation>
      <PMID>29870414</PMID>
    </reference>
    <reference>
      <citation>Hollo G. The side effects of the prostaglandin analogues. Expert Opin Drug Saf. 2007 Jan;6(1):45-52. doi: 10.1517/14740338.6.1.45.</citation>
      <PMID>17181451</PMID>
    </reference>
    <reference>
      <citation>Alm A. Latanoprost in the treatment of glaucoma. Clin Ophthalmol. 2014 Sep 26;8:1967-85. doi: 10.2147/OPTH.S59162. eCollection 2014.</citation>
      <PMID>25328381</PMID>
    </reference>
    <reference>
      <citation>van der Valk R, Webers CA, Schouten JS, Zeegers MP, Hendrikse F, Prins MH. Intraocular pressure-lowering effects of all commonly used glaucoma drugs: a meta-analysis of randomized clinical trials. Ophthalmology. 2005 Jul;112(7):1177-85. doi: 10.1016/j.ophtha.2005.01.042.</citation>
      <PMID>15921747</PMID>
    </reference>
    <reference>
      <citation>Gazzard G, Konstantakopoulou E, Garway-Heath D, Garg A, Vickerstaff V, Hunter R, Ambler G, Bunce C, Wormald R, Nathwani N, Barton K, Rubin G, Buszewicz M; LiGHT Trial Study Group. Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial. Lancet. 2019 Apr 13;393(10180):1505-1516. doi: 10.1016/S0140-6736(18)32213-X. Epub 2019 Mar 9. Erratum In: Lancet. 2019 Jul 6;394(10192):e1.</citation>
      <PMID>30862377</PMID>
    </reference>
    <reference>
      <citation>Leske MC, Heijl A, Hyman L, Bengtsson B, Komaroff E. Factors for progression and glaucoma treatment: the Early Manifest Glaucoma Trial. Curr Opin Ophthalmol. 2004 Apr;15(2):102-6. doi: 10.1097/00055735-200404000-00008.</citation>
      <PMID>15021220</PMID>
    </reference>
    <reference>
      <citation>Prum BE Jr, Rosenberg LF, Gedde SJ, Mansberger SL, Stein JD, Moroi SE, Herndon LW Jr, Lim MC, Williams RD. Primary Open-Angle Glaucoma Preferred Practice Pattern((R)) Guidelines. Ophthalmology. 2016 Jan;123(1):P41-P111. doi: 10.1016/j.ophtha.2015.10.053. Epub 2015 Nov 12. Erratum In: Ophthalmology. 2018 Jun;125(6):949.</citation>
      <PMID>26581556</PMID>
    </reference>
    <reference>
      <citation>Weinreb RN, Aung T, Medeiros FA. The pathophysiology and treatment of glaucoma: a review. JAMA. 2014 May 14;311(18):1901-11. doi: 10.1001/jama.2014.3192.</citation>
      <PMID>24825645</PMID>
    </reference>
    <reference>
      <citation>Schuster AK, Wagner FM, Pfeiffer N, Hoffmann EM. Risk factors for open-angle glaucoma and recommendations for glaucoma screening. Ophthalmologe. 2021 Jul;118(Suppl 2):145-152. doi: 10.1007/s00347-021-01378-5. Epub 2021 Apr 21.</citation>
      <PMID>33881589</PMID>
    </reference>
    <reference>
      <citation>Flaxman SR, Bourne RRA, Resnikoff S, Ackland P, Braithwaite T, Cicinelli MV, Das A, Jonas JB, Keeffe J, Kempen JH, Leasher J, Limburg H, Naidoo K, Pesudovs K, Silvester A, Stevens GA, Tahhan N, Wong TY, Taylor HR; Vision Loss Expert Group of the Global Burden of Disease Study. Global causes of blindness and distance vision impairment 1990-2020: a systematic review and meta-analysis. Lancet Glob Health. 2017 Dec;5(12):e1221-e1234. doi: 10.1016/S2214-109X(17)30393-5. Epub 2017 Oct 11.</citation>
      <PMID>29032195</PMID>
    </reference>
    <reference>
      <citation>GBD 2019 Blindness and Vision Impairment Collaborators; Vision Loss Expert Group of the Global Burden of Disease Study. Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to VISION 2020: the Right to Sight: an analysis for the Global Burden of Disease Study. Lancet Glob Health. 2021 Feb;9(2):e144-e160. doi: 10.1016/S2214-109X(20)30489-7. Epub 2020 Dec 1. Erratum In: Lancet Glob Health. 2021 Apr;9(4):e408.</citation>
      <PMID>33275949</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universidade Federal de Goias</investigator_affiliation>
      <investigator_full_name>David Leonardo Cruvinel Isaac</investigator_full_name>
      <investigator_title>Clinical Professor</investigator_title>
    </responsible_party>
    <keyword>prostaglandin analogue</keyword>
    <keyword>macular edema</keyword>
    <keyword>trabeculectomy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glaucoma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The data collected in the exams performed in the study and the data of the results will be made available</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Data can be shared 6 months after publication</ipd_time_frame>
      <ipd_access_criteria>Data sharing can be done after the consent of the main investigator of the study signed and sent by e-mail. Study principal investigator will review sharing requests</ipd_access_criteria>
      <ipd_url>https://www.gov.br/governodigital/pt-br/governanca-de-dados/regras-de-compartilhamento_v1-0.pdf</ipd_url>
    </patient_data>
    <study_docs>
      <study_doc>
        <doc_id>Repositorio</doc_id>
        <doc_type>Informed Consent Form</doc_type>
        <doc_url>http://repositorio.bc.ufg.br</doc_url>
        <doc_comment>Repositorio da Biblioteca Central da Universidade Federal de Goias</doc_comment>
      </study_doc>
    </study_docs>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06000280
  org study id: CEROF
  nct id: NCT06000280
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study was to verify whether prostaglandin analogue (PA) eye drops influence
        the retinal thickness of glaucomatous patients undergoing trabeculectomy (TRAB) surgery. We
        selected eyes of patients with glaucoma with surgical indication for TRAB who were using PA
        eye drops and without previous retinal alterations, from the Centro de Referência em
        Oftalmologia (CEROF) from the Federal University of Goiás and Fundação Banco de Olhos de
        Goiás (FUBOG). Patients were divided into 2 groups: the study group (SG) and the control
        group (CG). In the CG, the PA was suspended between 30 and 60 days before the preoperative
        exams were performed (maximum of 15 days before surgery for both groups). All patients
        included were submitted to various eye exams before the procedure, and postoperatively on 3
        occasions: 1 to 3 days ("PO1"), 6 to 9 days ("PO7") and 27 to 30 days ("PO30") after surgery.
  Purpose: The aim of this study was to verify whether topical prostaglandin analogue (PA)
        influence the macular thickness of glaucomatous patients undergoing trabeculectomy (TRAB)
        with Mitomycin C (MMC) .
  
        Design:This is a randomized, prospective, comparative clinical trial with a single surgeon
        and masked to the study group.
  
        Methods: We prospectively selected 40 eyes of patients with glaucoma with surgical indication
        for TRAB with MMC (0.4 mg/ml for 2 min) who were using prostaglandin analogue (PA) eye drops
        and without previous macular alterations, from the Centro de Referência em Oftalmologia
        (CEROF) from the Federal University of Goiás and Fundação Banco de Olhos de Goiás (FUBOG).
        The research had as inclusion criteria: patients with at least 18 years of age with Primary
        Glaucoma (Primary Open Angle Glaucoma, Primary Closed Angle Glaucoma, Normal Pressure
        Glaucoma, Pigmentary Glaucoma, Pseudoesfoliative Glaucoma), with changes in the visual field,
        typical defect compatible with glaucomatous lesion and/or typical anatomical impairment of
        the optic disc or retinal nerve fiber layer (such as Hoyt's sign, optic disc cupping ratio
        greater than 0.7, localized defect in the neural rima, or cupping asymmetry), who had an
        indication for TRAB with MMC at the physician's discretion (target IOP not established with
        maximum tolerable clinical medication and/or impossibility of using medication due to
        allergies and/or financial conditions). To be included, the operated eyes needed a reduction
        in IOP of at least 20% in relation to the baseline IOP in the last postoperative period (PO
        30), and absence of the use of any ocular hypotensive medication. Exclusion criteria were any
        pathology that could interfere with the test results, such as: cataracts, corneal edema (such
        as leucoma, ulcers, keratopathies); poor quality of the OCT scan (signal strength ≤ 5/10);
        any past macular pathology (such as macular hole, diabetic maculopathy, age-related macular
        disease); use of diamox; advanced glaucoma with maximal therapy; advanced glaucoma with
        impaired fixation; any surgical complications including hypotonia (IOP < 6 mmHg) at any
        assessment; performing combined cataract and glaucoma surgery; history of cataract surgery
        less than 6 months ago; need for surgical reintervention during follow-up for any reason; and
        need for reintroduction of topical antiglaucoma therapy during follow-up. Eligible volunteers
        were previously randomized through the website www.randomization.com into 2 groups: study
        group (SG) and control group (CG). The initial objective was to include 40 eyes, 20 per
        group.
  
        In the SG, patients were instructed to keep using eyedrops (including PA) until the day of
        surgery. In the CG, patients were instructed to suspend the PA between 30-60 days after the
        preoperative exams were performed, which were performed a maximum of 15 days before surgery
        for both groups. In the CG, patients were instructed to use 01 drop of carmellose sodium
        5mg/ml at the same time they used the AP before its suspension. Pseudophakic patients for
        more than six months were included in each group in the order of previous randomization. In
        the CG, patients were informed to keep the eye drops in use, and to add the other classes of
        ocular hypotensive drugs, if they were not using them (except miotics and oral
        acetazolamide), with the aim of at least remedying the loss of the ocular hypotensive effect
        of the PA. The individuals were evaluated, including best corrected visual acuity by the
        Snellen chart, slit lamp biomicroscopy (XCELL 255, Reichert Inc., Depew, NY, USA),
        intraocular pressure (IOP) measured in a calibrated Goldmann tonometer (CT210, Reichert Inc.
        , Depew, NY, USA), gonioscopy with a 4-mirror Goldman lens (Volk Optical Inc, Mentor, OH,
        USA), fundoscopy under mydriasis with a 78D lens (Volk Optical Inc, Mentor, OH, USA),
        indirect binocular ophthalmoscopy with 2.0D lens (Volk Optical Inc, Mentor, OH, USA) and
        Optical Coherence Tomography (OCT) with Cirrus 4000 (Zeiss Inc.), macular protocol (macular
        thickness and ganglion cell analysis) preoperatively ( maximum of 15 days before surgery),
        and postoperatively on 3 occasions: 1 to 3 days ("PO1"), 6 to 9 days ("PO7") and 27 to 30
        days ("PO30"). All tests were performed by the same technician, who was trained and
        experienced to carry them out. All patients underwent visual field examinations (Humphrey
        Field, model HFA II ÿ750, Carl Zeiss-Meditec, Dublin, California, USA) prior to surgery with
        the Swedish Interactive Threshold Algorithm (SITA) Standard 24-2 strategy, at most up to 2
        months before the procedure. Macular thickness was evaluated by spectral domain Optical
        Coherence Tomography (OCT) obtained using the Cirrus 4000 apparatus (Zeiss Inc.), macular
        scanning protocol (macular thickness and ganglion cell analysis). Calculations were made
        based on data from the Ganglion cell analytical program and Macular Thickness: Macular cube
        (6 x 6 mm - 512 A-scans x 128 B-scans centered on the fovea). The macular thickness map using
        the 1mm, 3mm, and 6mm circles from the Early Treatment Diabetic Retinopathy Study (ETDRS) was
        used to assess the thickness of the 9 subfields. The regions were designated as: parafoveal
        (subfields of the 3 mm rings) and perifoveal (subfields of the 6 mm rings) superior,
        inferior, temporal and nasal in addition to the central subfield. OCT images were excluded if
        the signal strength was ≤5/10, and a new scan was immediately performed. Trabeculectomy using
        mitomycin C consisted of opening the conjunctival base of the fornix and applying mitomycin C
        0.4 mg/ml for 2 minutes, as previously described. The postoperative regimen in both groups
        included the use of 1% Prednisolone eye drops (Ster® União Química Farmacêutica Nacional
        S/A., Pouso Alegre, MG, Brazil) starting every 2 hours, with a weekly reduction for 6 weeks (
        4/4 h, followed by 6/6 h, then every 8 h, 12/12 h and once a day), Moxifloxacin eye drops
        (Vigamox®, AlconLabs, Fort Worth, TX, USA) every 6 h for 10 days.
  
        Statistical analysis was performed using the Statistical Package for Social Sciences program
        (IBM Corporation, Armonk, USA) version 26.0. The characterization of the sample was performed
        using absolute frequency, relative frequency, mean, standard deviation, median, minimum and
        maximum. Student's t test and Pearson's chi-square test were applied to the distribution of
        profile and macular parameters in groups with and without prostaglandin. Data normality was
        verified using the Shapiro-Wilk test. The delta and percentage variation were calculated at
        PO1, PO7 and PO30 in relation to the preoperative period. Correlation analysis was performed
        between thickness deltas with visual field Mean Deviation (MD) and IOP in groups with and
        without prostaglandin, weighted the effect of lens classification (partial correlation). The
        significance level adopted was 5% (p < 0.05).
  
        Initially, 40 eyes were randomly assigned to the study, of which 17 were excluded because
        they did not meet the eligibility criteria for the study postoperatively. Among these, 4
        patients did not undergo OCT at PO1, 4 patients did not undergo OCT at PO7, 2 patients did
        not undergo OCT at PO30, 1 patient had a signal ≤ 5/10 of OCT at all visits, even with
        several repetitions of the examinations, 3 patients underwent surgical reintervention during
        follow-up (suture dehiscence), 2 patients had hypotonia, finally 1 patient did not present
        IOP reduction by at least 20% of baseline. Thus, as there was a significant reduction in the
        number of patients initially estimated for the sample, a new randomization was performed,
        using the same initial randomization process described above to achieve this objective. In
        the end, the evaluated sample consisted of 40 eyes from 37 patients, 20 eyes per group (20
        eyes from 18 patients in the CG and 20 eyes from 19 patients in the SG).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a randomized, prospective and comparative clinical trial. Both the surgeon (the only one) and the technician responsible for the exams were blinded to the study groups. The patients (one or both eyes) included were from the glaucoma outpatient clinic of the Fundação Banco de Olhos de Goiás (FUBOG) or the Reference Center in Ophthalmology (CEROF) of the Federal University of Goiás (UFG) between the years 202 and 2022. All patients with glaucoma with indication for Trab with MMC and in clinical use of any PA eye drops (latanoprost, travoprost, bimatoprost or tafluprost) in the eye to be operated on for at least 6 months were considered for inclusion.
  The study adhered to the principles of the Declaration of Helsinki and was authorized by the Research Ethics Committee of the UFG, under the Certificate of Presentation for Ethical Appreciation NUMBER 40055620.8.1001.5083. All those included voluntarily agreed to participate by signing the Free and Informed Consent Form.
  primary purpose: Prevention
  masking: Double (Investigator, Outcomes Assessor)
  masking description: The techinician who performed the exams (Optical Coherence Tomography and Visual Field)
  measure: Previous use of prostaglandins does not change macular thickness after trabeculectomy
  time frame: Measurements were performed at preop (up to 15 days before the intervention), 1 to 3 days ("PO1"), 6 to 9 days ("PO7") and 27 to 30 days ("PO30") after surgery.
  description: The absolute variation of each variable of the macular parameters OCT in relation to the pre-op was performed and its comparison between the groups at different moments. There was equivalence in most of the evaluated comparisons. Considering the variation between pre-op and PO30, only the upper parafoveal thickness was statistically different between groups (p= 0.01). Taking into account the difference in percentage analyzing pre-op vs. PO30, only the superior parafoveal thickness showed statistical significance between groups (p=0.01).
  measure: The presence of the lens did not influence the correlations
  time frame: Measurements were performed at preop (up to 15 days before the intervention) and 27 to 30 days ("PO30") after surgery.
  description: Correlations were performed between the deltas of the thicknesses of the macular parameters between the preoperative period and the PO30 within the groups with the possible confounding factors (MD and IOP) and also controlling the intensity of the lens effect (partial correlation). There was no significant correlation in the other tests performed, as well as in relation to the possible influence of the crystalline lens in each of them.
  arm group label: Study group
  arm group type: Active Comparator
  description: The Study group refers to patients who are using topical prostaglandins analogues
  arm group label: Control group
  arm group type: Placebo Comparator
  description: The Control group refers to patients who discontinued the use of topical prostaglandins analogues
  intervention type: Procedure
  intervention name: Trabeculectomy surgery
  description: The Trabeculectomy aims to create a permanent drainage outflow channel for the aqueous humor, connecting the anterior chamber to the sub-Tenon's space, using mitomycin C consisted of opening the conjunctival base of the fornix and applying mitomycin C 0.4 mg/ml for 2 minutes. The trabeculectomy techniques require controlled outflow of aqueous humor through a sclerostomy and a partial-thickness scleral flap to form a subconjunctival bleb. The protected strength of the flap, with or without sutures, and the strength of the episcleral tissue determine the final IOP.
  arm group label: Control group
  arm group label: Study group
  criteria: 
  gender: All
  gender based: Yes
  gender description: Individuals self-identified as male and female were eligible for the study.
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Leopoldo Magacho dos Santos Silva, Doctor
  role: Study Director
  affiliation: Universidade Federal de Goias
  facility: 
  country: Brazil
  url: https://cerof.ufg.br
  description: Centro de Referencia em Oftalmologia
  citation: Motero Carrasco J. [A comparative study of the efficacy of lisinopril versus quinapril in controlling light to moderate arterial hypertension. A follow-up with ABPM]. Rev Esp Cardiol. 1995 Nov;48(11):746-53. Spanish.
  PMID: 8532944
  citation: Yonekawa Y, Kim IK. Pseudophakic cystoid macular edema. Curr Opin Ophthalmol. 2012 Jan;23(1):26-32. doi: 10.1097/ICU.0b013e32834cd5f8.
  PMID: 22134362
  citation: Vessani R, Frota T, Shigetomi G, Correa P, Mariottoni EB, Tavares I. Structural Changes in the Optic Disc and Macula Detected by Swept-Source Optical Coherence Tomography After Surgical Intraocular Pressure Reduction in Patients with Open-Angle Glaucoma. Clin Ophthalmol. 2021 Jul 14;15:3017-3026. doi: 10.2147/OPTH.S317190. eCollection 2021.
  PMID: 34285468
  citation: Francoz M, Fenolland JR, Giraud JM, El Chehab H, Sendon D, May F, Renard JP. Reproducibility of macular ganglion cell-inner plexiform layer thickness measurement with cirrus HD-OCT in normal, hypertensive and glaucomatous eyes. Br J Ophthalmol. 2014 Mar;98(3):322-8. doi: 10.1136/bjophthalmol-2012-302242. Epub 2013 Dec 4.
  PMID: 24307717
  citation: Lavinsky F, Wu M, Schuman JS, Lucy KA, Liu M, Song Y, Fallon J, de Los Angeles Ramos Cadena M, Ishikawa H, Wollstein G. Can Macula and Optic Nerve Head Parameters Detect Glaucoma Progression in Eyes with Advanced Circumpapillary Retinal Nerve Fiber Layer Damage? Ophthalmology. 2018 Dec;125(12):1907-1912. doi: 10.1016/j.ophtha.2018.05.020. Epub 2018 Jun 19.
  PMID: 29934267
  citation: Klink T, Lieb WE, Gobel W. [Early and late findings with optical coherence tomography (OCT) in patients with postoperative hypotonia]. Ophthalmologe. 2000 May;97(5):353-8. doi: 10.1007/s003470050536. German.
  PMID: 10892280
  citation: Kim WJ, Kim KN, Sung JY, Kim JY, Kim CS. Relationship between preoperative high intraocular pressure and retinal nerve fibre layer thinning after glaucoma surgery. Sci Rep. 2019 Sep 25;9(1):13901. doi: 10.1038/s41598-019-50406-7.
  PMID: 31554879
  citation: Kadziauskiene A, Strelkauskaite E, Mockeviciute E, Asoklis R, Lesinskas E, Schmetterer L. Changes in macular thickness after trabeculectomy with or without adjunctive 5-fluorouracil. Acta Med Litu. 2017;24(2):93-100. doi: 10.6001/actamedica.v24i2.3489.
  PMID: 28845126
  citation: Raghu N, Pandav SS, Kaushik S, Ichhpujani P, Gupta A. Effect of trabeculectomy on RNFL thickness and optic disc parameters using optical coherence tomography. Eye (Lond). 2012 Aug;26(8):1131-7. doi: 10.1038/eye.2012.115. Epub 2012 Jun 22.
  PMID: 22722487
  citation: Silva D, Lopes AS, Henriques S, Lisboa M, Pinto S, Trancoso Vaz F, Prieto I. Changes in choroidal thickness following trabeculectomy and its correlation with the decline in intraocular pressure. Int Ophthalmol. 2019 May;39(5):1097-1104. doi: 10.1007/s10792-018-0918-y. Epub 2018 Apr 16.
  PMID: 29663109
  citation: Diaconita V, Quinn M, Jamal D, Dishan B, Malvankar-Mehta MS, Hutnik C. Washout Duration of Prostaglandin Analogues: A Systematic Review and Meta-analysis. J Ophthalmol. 2018 Sep 27;2018:3190684. doi: 10.1155/2018/3190684. eCollection 2018.
  PMID: 30363694
  citation: Mishima H, Masuda K, Miyake K. The putative role of prostaglandins in cystoid macular edema. Prog Clin Biol Res. 1989;312:251-64. No abstract available.
  PMID: 2678143
  citation: Taheri PA, Karamanoukian H, Gibbons K, Waldman N, Doerr RJ, Hoover EL. Can patients with minor head injuries be safely discharged home? Arch Surg. 1993 Mar;128(3):289-92. doi: 10.1001/archsurg.1993.01420150043008.
  PMID: 8442684
  citation: Gupta P, Sidhartha E, Tham YC, Chua DK, Liao J, Cheng CY, Aung T, Wong TY, Cheung CY. Determinants of macular thickness using spectral domain optical coherence tomography in healthy eyes: the Singapore Chinese Eye study. Invest Ophthalmol Vis Sci. 2013 Dec 5;54(13):7968-76. doi: 10.1167/iovs.13-12436.
  PMID: 24222307
  citation: Lichter PR. Variability of expert observers in evaluating the optic disc. Trans Am Ophthalmol Soc. 1976;74:532-72.
  PMID: 867638
  citation: Manabe K, Matsuoka Y, Tanito M. Incidence of macular edema development after filtration surgery. Graefes Arch Clin Exp Ophthalmol. 2020 Jun;258(6):1343-1345. doi: 10.1007/s00417-020-04624-9. Epub 2020 Feb 13. No abstract available.
  PMID: 32055953
  citation: Belyea DA, Dan JA, Lieberman MF, Stamper RL. Midterm follow-up results of combined phacoemulsification, lens implantation, and mitomycin-C trabeculectomy procedure. J Glaucoma. 1997 Apr;6(2):90-8.
  PMID: 9098816
  citation: Sesar A, Cavar I, Sesar AP, Geber MZ, Sesar I, Laus KN, Vatavuk Z, Mandic Z. Macular thickness after glaucoma filtration surgery. Coll Antropol. 2013 Sep;37(3):841-5.
  PMID: 24308226
  citation: Karasheva G, Goebel W, Klink T, Haigis W, Grehn F. Changes in macular thickness and depth of anterior chamber in patients after filtration surgery. Graefes Arch Clin Exp Ophthalmol. 2003 Mar;241(3):170-5. doi: 10.1007/s00417-003-0628-6. Epub 2003 Feb 20.
  PMID: 12644938
  citation: Pitale PM, Chatha U, Patel V, Gupta L, Waisbourd M, Pro MJ. Changes in macular thickness following glaucoma surgery. Int J Ophthalmol. 2016 Aug 18;9(8):1236-7. doi: 10.18240/ijo.2016.08.24. eCollection 2016. No abstract available.
  PMID: 27588282
  citation: Demirtas AA, Karahan M, Erdem S, Aslan Kaya A, Keklikci U. Long-term effects of trabeculectomy in primary open-angle glaucoma on segmented macular ganglion cell complex alterations. Int Ophthalmol. 2021 Jun;41(6):2249-2263. doi: 10.1007/s10792-021-01840-y. Epub 2021 Apr 21.
  PMID: 33880684
  citation: Nilforushan N, Loni S, Abdolalizadeh P, Miraftabi A, Banifatemi M, Rakhshan R, Jafari S, Abolfathzadeh N. Early Macular Thickness Changes after Trabeculectomy and Combined Phaco-Trabeculectomy. J Curr Ophthalmol. 2022 Jul 26;34(2):160-166. doi: 10.4103/joco.joco_333_21. eCollection 2022 Apr-Jun.
  PMID: 36147280
  citation: Wagner FM, Schuster AK, Kianusch K, Stingl J, Pfeiffer N, Hoffmann EM. Long-term success after trabeculectomy in open-angle glaucoma: results of a retrospective cohort study. BMJ Open. 2023 Feb 3;13(2):e068403. doi: 10.1136/bmjopen-2022-068403.
  PMID: 36737088
  citation: Koike KJ, Chang PT. Trabeculectomy: A Brief History and Review of Current Trends. Int Ophthalmol Clin. 2018 Summer;58(3):117-133. doi: 10.1097/IIO.0000000000000231. No abstract available.
  PMID: 29870414
  citation: Hollo G. The side effects of the prostaglandin analogues. Expert Opin Drug Saf. 2007 Jan;6(1):45-52. doi: 10.1517/14740338.6.1.45.
  PMID: 17181451
  citation: Alm A. Latanoprost in the treatment of glaucoma. Clin Ophthalmol. 2014 Sep 26;8:1967-85. doi: 10.2147/OPTH.S59162. eCollection 2014.
  PMID: 25328381
  citation: van der Valk R, Webers CA, Schouten JS, Zeegers MP, Hendrikse F, Prins MH. Intraocular pressure-lowering effects of all commonly used glaucoma drugs: a meta-analysis of randomized clinical trials. Ophthalmology. 2005 Jul;112(7):1177-85. doi: 10.1016/j.ophtha.2005.01.042.
  PMID: 15921747
  citation: Gazzard G, Konstantakopoulou E, Garway-Heath D, Garg A, Vickerstaff V, Hunter R, Ambler G, Bunce C, Wormald R, Nathwani N, Barton K, Rubin G, Buszewicz M; LiGHT Trial Study Group. Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial. Lancet. 2019 Apr 13;393(10180):1505-1516. doi: 10.1016/S0140-6736(18)32213-X. Epub 2019 Mar 9. Erratum In: Lancet. 2019 Jul 6;394(10192):e1.
  PMID: 30862377
  citation: Leske MC, Heijl A, Hyman L, Bengtsson B, Komaroff E. Factors for progression and glaucoma treatment: the Early Manifest Glaucoma Trial. Curr Opin Ophthalmol. 2004 Apr;15(2):102-6. doi: 10.1097/00055735-200404000-00008.
  PMID: 15021220
  citation: Prum BE Jr, Rosenberg LF, Gedde SJ, Mansberger SL, Stein JD, Moroi SE, Herndon LW Jr, Lim MC, Williams RD. Primary Open-Angle Glaucoma Preferred Practice Pattern((R)) Guidelines. Ophthalmology. 2016 Jan;123(1):P41-P111. doi: 10.1016/j.ophtha.2015.10.053. Epub 2015 Nov 12. Erratum In: Ophthalmology. 2018 Jun;125(6):949.
  PMID: 26581556
  citation: Weinreb RN, Aung T, Medeiros FA. The pathophysiology and treatment of glaucoma: a review. JAMA. 2014 May 14;311(18):1901-11. doi: 10.1001/jama.2014.3192.
  PMID: 24825645
  citation: Schuster AK, Wagner FM, Pfeiffer N, Hoffmann EM. Risk factors for open-angle glaucoma and recommendations for glaucoma screening. Ophthalmologe. 2021 Jul;118(Suppl 2):145-152. doi: 10.1007/s00347-021-01378-5. Epub 2021 Apr 21.
  PMID: 33881589
  citation: Flaxman SR, Bourne RRA, Resnikoff S, Ackland P, Braithwaite T, Cicinelli MV, Das A, Jonas JB, Keeffe J, Kempen JH, Leasher J, Limburg H, Naidoo K, Pesudovs K, Silvester A, Stevens GA, Tahhan N, Wong TY, Taylor HR; Vision Loss Expert Group of the Global Burden of Disease Study. Global causes of blindness and distance vision impairment 1990-2020: a systematic review and meta-analysis. Lancet Glob Health. 2017 Dec;5(12):e1221-e1234. doi: 10.1016/S2214-109X(17)30393-5. Epub 2017 Oct 11.
  PMID: 29032195
  citation: GBD 2019 Blindness and Vision Impairment Collaborators; Vision Loss Expert Group of the Global Burden of Disease Study. Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to VISION 2020: the Right to Sight: an analysis for the Global Burden of Disease Study. Lancet Glob Health. 2021 Feb;9(2):e144-e160. doi: 10.1016/S2214-109X(20)30489-7. Epub 2020 Dec 1. Erratum In: Lancet Glob Health. 2021 Apr;9(4):e408.
  PMID: 33275949
  responsible party type: Principal Investigator
  investigator affiliation: Universidade Federal de Goias
  investigator full name: David Leonardo Cruvinel Isaac
  investigator title: Clinical Professor
  mesh term: Glaucoma
  sharing ipd: Yes
  ipd description: The data collected in the exams performed in the study and the data of the results will be made available
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: Data can be shared 6 months after publication
  ipd access criteria: Data sharing can be done after the consent of the main investigator of the study signed and sent by e-mail. Study principal investigator will review sharing requests
  ipd url: https://www.gov.br/governodigital/pt-br/governanca-de-dados/regras-de-compartilhamento_v1-0.pdf
  study doc: 