<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/NCT03014349</url>
  </required_header>
  <id_info>
    <org_study_id>VEREO</org_study_id>
    <nct_id>NCT03014349</nct_id>
  </id_info>
  <brief_title>Water Drinking Test and Its Reproducibility in Goldmann Applanation Tonometry and Pneumatic Tonometry</brief_title>
  <acronym>WDTRGP</acronym>
  <official_title>Water Drinking Test and Its Reproducibility in Goldmann Applanation Tonometry and Pneumatic Tonometry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VER Excelência em Oftalmologia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VER Excelência em Oftalmologia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the reproducibility of tonometry in the Goldmann&#xD;
      applanation apparatus and pneumatic in the water drinking test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Glaucoma consists of a multifactorial disease caused by a deficiency in drainage of the&#xD;
      aqueous humor, which may cause an increase in intraocular pressure (IOP), an impairment of&#xD;
      the optic nerve and visual field changes. According to the most recent data , this disease is&#xD;
      the second cause of blindness in the world (12.3%). An estimate indicates that, by 2020,&#xD;
      there will be 79.6 million glaucomatous individuals in the world. The estimated prevalence of&#xD;
      primary glaucoma in the Brazilian population was 3.4%, consisting of 2.4% open angle and 0.7%&#xD;
      closed angle.&#xD;
&#xD;
      Glaucoma can be: open angle, angle-closure, congenital or secondary. Increased IOP is the&#xD;
      major risk factor for glaucoma progression as well as its fluctuation (difference between the&#xD;
      highest and lowest IOP measure) in primary open-angle glaucoma (POAG). In addition, age,&#xD;
      family history, central corneal thickness, race, high myopia, hypermetropia, diabetes&#xD;
      mellitus, hypertension and hypotension, gender, optic disc hemorrhages, suspected optic nerve&#xD;
      excavation, and cardiovascular and cerebrovascular diseases.&#xD;
&#xD;
      The treatment depends on the classification of glaucoma, since in the POAG, the initial&#xD;
      treatment is with topical monotherapy (ocular hypotensors). However, in some situations, drug&#xD;
      treatment is not enough to stabilize the process of glaucomatous progression. In these cases,&#xD;
      incisional surgery or laser treatment is necessary.&#xD;
&#xD;
      Trabeculectomy consists of an intervention to increase drainage of the aqueous humor, in&#xD;
      order to control the IOP and prevent the progression of the disease. However, due to its&#xD;
      complications, such as atalamia, hypotonia, the development of cataract and the risk of&#xD;
      endophthalmitis, this procedure is indicated in the refractory cases to clinical and/or laser&#xD;
      treatment. Thus, clinical treatment and trabeculoplasty are the treatments of choice.&#xD;
      Trabeculoplasty is indicated in the cases of POAG, pseudoexfoliative, pigmented and in some&#xD;
      cases of secondary and trabecular glaucoma visible to the gonioscopy.&#xD;
&#xD;
      The tonometer is the device used to detect IOP increase. Despite the existence of several&#xD;
      models, Goldmann's applanation is considered the gold standard for this measurement, since it&#xD;
      evaluates the force necessary to deform the surface of the cornea. This method is quite&#xD;
      accurate, however, errors may occur in the result due to fluorescein patterns, very thick&#xD;
      corneas, excessive pressure on the eyeball when holding the patient's eyelids or elevated&#xD;
      corneal astigmatism without the adequate compensatory positioning of the planer.&#xD;
&#xD;
      The measurement of IOP can also be performed through another type of tonometer: non-contact,&#xD;
      pneumatic or blow. It was first used in 1973 by Forbes and its advantages are: 1) no need for&#xD;
      the use of eye drops, 2) it can be performed by people who are not doctors, 3) it has a low&#xD;
      risk of contamination and 4) it can be used for screening programs. However, a study by Britt&#xD;
      et al. showed the presence of lachrymal film dehiscence and the existence of microaerosol&#xD;
      with the air blow, which would make this method not so aseptic.&#xD;
&#xD;
      According to the study, where the pneumatic tonometer was compared with that of Goldmann, the&#xD;
      results obtained were: 50% of the evaluated eyes showed no differences between the two&#xD;
      devices and in 85% they were between approximately 2 mmHg. In another study which compared&#xD;
      the IOP values measured by the mentioned tonometers, it was verified that the pneumatic&#xD;
      tonometer underestimates the IOP values, compared to Goldmann, in thin corneas; however,&#xD;
      there is no significant difference between the measurements of the two tonometers in thick&#xD;
      corneas.&#xD;
&#xD;
      The Water Drinking Test (WDT) is a propaedeutic widely used to evaluate the maximum&#xD;
      intraocular pressure (IOP) and its fluctuation. These data are extremely important for the&#xD;
      expected result in relation to the reproducibility of the exams, since in the study , showed&#xD;
      that the WDT can be used to estimate the peak and diurnal fluctuation of supine IOP in the&#xD;
      simplified daily stress curve (another method for the same purpose of the WDT) in patients&#xD;
      under treatment for glaucoma.&#xD;
&#xD;
      Glaucoma is a serious eye health problem, as it has a high incidence and prevalence worldwide&#xD;
      and is the leading cause of irreversible blindness in the world. Therefore, it is extremely&#xD;
      important to perform tests that will detect altered IOP values.&#xD;
&#xD;
      The IOP values obtained over a 24 hour period are important data, since they are required to&#xD;
      control and conduct the treatment of glaucoma. In the past, the WDT has often been used to&#xD;
      diagnose patients with this pathology. Due to a series of studies,it was found that the WDT&#xD;
      can not be used as a diagnostic test, but as a tool to evaluate changes in IOP peaks. In&#xD;
      addition, a comparison of reproducibility between devices will facilitate a better&#xD;
      evaluation, speed, safety and efficacy in the treatment, contributing to increase the quality&#xD;
      of life of the patient and also to guide other studies in this area.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Water drinking test and its reproducibility in Goldmann applanation tonometry</measure>
    <time_frame>Six months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Water drinking test and its reproducibility in pneumatic tonometry</measure>
    <time_frame>Six months</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Glaucoma Suspect</condition>
  <arm_group>
    <arm_group_label>primary open-angle glaucoma and/or glaucoma suspects</arm_group_label>
    <description>Individuals with primary open-angle glaucoma and/or glaucoma suspects, selected from the electronic records of the VER Hospital. The following variables will be observed: gender, age, race, systemic diseases, intraocular pressure, type of glaucoma, complementary exams and degree of evolution. All patients were given a complete ophthalmologic examination, including Goldmann and pneumatic tonometry.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Analysis of medical records</intervention_name>
    <description>Individuals with primary open-angle glaucoma and/or glaucoma suspects, selected from the electronic records of the VER Hospital. The following variables will be observed: gender, age, race, systemic diseases, intraocular pressure, type of glaucoma, complementary exams and degree of evolution. All patients were given a complete ophthalmologic examination, including Goldmann and pneumatic tonometry.</description>
    <arm_group_label>primary open-angle glaucoma and/or glaucoma suspects</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will be composed of individuals with primary open-angle glaucoma&#xD;
        and/or glaucoma suspects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older than 18 years&#xD;
&#xD;
          -  Intraocular pressure greater than 21 mmhg&#xD;
&#xD;
          -  Optic neuropathy more than 0.5&#xD;
&#xD;
          -  CampimetryPerimetric suggestive of glaucoma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Were patients under 18 years of age&#xD;
&#xD;
          -  Incomplete data in electronic records&#xD;
&#xD;
          -  Had previous ophthalmologic surgeries or other non-glaucoma-related ophthalmic&#xD;
             diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Wachtl J, Toteberg-Harms M, Frimmel S, Kniestedt C. [Evaluation of correction formulas for tonometry : The Goldmann applanation tonometry in approximation to dynamic contour tonometry]. Ophthalmologe. 2017 Aug;114(8):716-721. doi: 10.1007/s00347-016-0409-3. German.</citation>
    <PMID>27921133</PMID>
  </reference>
  <reference>
    <citation>Sakata R, Aihara M, Murata H, Saito H, Iwase A, Yasuda N, Araie M. Intraocular pressure change over a habitual 24-hour period after changing posture or drinking water and related factors in normal tension glaucoma. Invest Ophthalmol Vis Sci. 2013 Aug 7;54(8):5313-20. doi: 10.1167/iovs.13-11792.</citation>
    <PMID>23821194</PMID>
  </reference>
  <reference>
    <citation>Medina FM, Rodrigues FK, Filho Pde T, Matsuo T, Vasconcellos JP, Costa VP. Reproducibility of water drinking test performed at different times of the day. Arq Bras Oftalmol. 2009 May-Jun;72(3):283-90. doi: 10.1590/s0004-27492009000300002.</citation>
    <PMID>19668954</PMID>
  </reference>
  <reference>
    <citation>Meirelles SH, Yamane R, Alvares RM, Botelho PB, Morais FB, Moreira PB, Dantas AM, de Moraes Junior HV. [Comparative study between diurnal intraocular pressure curve and the association of ambulatory intraocular pressure curve with the water-drinking test in open angle glaucoma, normal tension glaucoma and normal eyes]. Arq Bras Oftalmol. 2007 May-Jun;70(3):471-9. doi: 10.1590/s0004-27492007000300015. Portuguese.</citation>
    <PMID>17768555</PMID>
  </reference>
  <reference>
    <citation>Medeiros FA, Sample PA, Zangwill LM, Bowd C, Aihara M, Weinreb RN. Corneal thickness as a risk factor for visual field loss in patients with preperimetric glaucomatous optic neuropathy. Am J Ophthalmol. 2003 Nov;136(5):805-13. doi: 10.1016/s0002-9394(03)00484-7.</citation>
    <PMID>14597030</PMID>
  </reference>
  <reference>
    <citation>Caiado RR, Badaro E, Kasahara N. Intraocular pressure fluctuation in healthy and glaucomatous eyes: a comparative analysis between diurnal curves in supine and sitting positions and the water drinking test. Arq Bras Oftalmol. 2014 Oct;77(5):288-292. doi: 10.5935/0004-2749.20140073. Epub 2014 Sep 1.</citation>
    <PMID>25494373</PMID>
  </reference>
  <reference>
    <citation>Regev G, Harris A, Siesky B, Shoshani Y, Egan P, Moss A, Zalish M, WuDunn D, Ehrlich R. Goldmann applanation tonometry and dynamic contour tonometry are not correlated with central corneal thickness in primary open angle glaucoma. J Glaucoma. 2011 Jun-Jul;20(5):282-6. doi: 10.1097/IJG.0b013e3181e66498.</citation>
    <PMID>20577097</PMID>
  </reference>
  <reference>
    <citation>Guler M, Bilak S, Bilgin B, Simsek A, Capkin M, Hakim Reyhan A. Comparison of Intraocular Pressure Measurements Obtained by Icare PRO Rebound Tonometer, Tomey FT-1000 Noncontact Tonometer, and Goldmann Applanation Tonometer in Healthy Subjects. J Glaucoma. 2015 Oct-Nov;24(8):613-8. doi: 10.1097/IJG.0000000000000132.</citation>
    <PMID>25264986</PMID>
  </reference>
  <reference>
    <citation>Quaranta L, Konstas AG, Rossetti L, Garcia-Feijoo J, O'Brien C, Nasr MB, Fogagnolo P, Demos CM, Stewart JA, Stewart WC. Untreated 24-h intraocular pressures measured with Goldmann applanation tonometry vs nighttime supine pressures with Perkins applanation tonometry. Eye (Lond). 2010 Jul;24(7):1252-8. doi: 10.1038/eye.2009.300. Epub 2009 Dec 4.</citation>
    <PMID>19960033</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 6, 2017</last_update_submitted>
  <last_update_submitted_qc>January 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>VER Excelência em Oftalmologia</investigator_affiliation>
    <investigator_full_name>Rodrigo Egidio da Silva</investigator_full_name>
    <investigator_title>ophthalmologist</investigator_title>
  </responsible_party>
  <keyword>Glaucoma</keyword>
  <keyword>Ocular hypertension</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>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03014349
org study id: VEREO
nct id: NCT03014349
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the reproducibility of tonometry in the Goldmann
      applanation apparatus and pneumatic in the water drinking test.
Glaucoma consists of a multifactorial disease caused by a deficiency in drainage of the
      aqueous humor, which may cause an increase in intraocular pressure (IOP), an impairment of
      the optic nerve and visual field changes. According to the most recent data , this disease is
      the second cause of blindness in the world (12.3%). An estimate indicates that, by 2020,
      there will be 79.6 million glaucomatous individuals in the world. The estimated prevalence of
      primary glaucoma in the Brazilian population was 3.4%, consisting of 2.4% open angle and 0.7%
      closed angle.

      Glaucoma can be: open angle, angle-closure, congenital or secondary. Increased IOP is the
      major risk factor for glaucoma progression as well as its fluctuation (difference between the
      highest and lowest IOP measure) in primary open-angle glaucoma (POAG). In addition, age,
      family history, central corneal thickness, race, high myopia, hypermetropia, diabetes
      mellitus, hypertension and hypotension, gender, optic disc hemorrhages, suspected optic nerve
      excavation, and cardiovascular and cerebrovascular diseases.

      The treatment depends on the classification of glaucoma, since in the POAG, the initial
      treatment is with topical monotherapy (ocular hypotensors). However, in some situations, drug
      treatment is not enough to stabilize the process of glaucomatous progression. In these cases,
      incisional surgery or laser treatment is necessary.

      Trabeculectomy consists of an intervention to increase drainage of the aqueous humor, in
      order to control the IOP and prevent the progression of the disease. However, due to its
      complications, such as atalamia, hypotonia, the development of cataract and the risk of
      endophthalmitis, this procedure is indicated in the refractory cases to clinical and/or laser
      treatment. Thus, clinical treatment and trabeculoplasty are the treatments of choice.
      Trabeculoplasty is indicated in the cases of POAG, pseudoexfoliative, pigmented and in some
      cases of secondary and trabecular glaucoma visible to the gonioscopy.

      The tonometer is the device used to detect IOP increase. Despite the existence of several
      models, Goldmann's applanation is considered the gold standard for this measurement, since it
      evaluates the force necessary to deform the surface of the cornea. This method is quite
      accurate, however, errors may occur in the result due to fluorescein patterns, very thick
      corneas, excessive pressure on the eyeball when holding the patient's eyelids or elevated
      corneal astigmatism without the adequate compensatory positioning of the planer.

      The measurement of IOP can also be performed through another type of tonometer: non-contact,
      pneumatic or blow. It was first used in 1973 by Forbes and its advantages are: 1) no need for
      the use of eye drops, 2) it can be performed by people who are not doctors, 3) it has a low
      risk of contamination and 4) it can be used for screening programs. However, a study by Britt
      et al. showed the presence of lachrymal film dehiscence and the existence of microaerosol
      with the air blow, which would make this method not so aseptic.

      According to the study, where the pneumatic tonometer was compared with that of Goldmann, the
      results obtained were: 50% of the evaluated eyes showed no differences between the two
      devices and in 85% they were between approximately 2 mmHg. In another study which compared
      the IOP values measured by the mentioned tonometers, it was verified that the pneumatic
      tonometer underestimates the IOP values, compared to Goldmann, in thin corneas; however,
      there is no significant difference between the measurements of the two tonometers in thick
      corneas.

      The Water Drinking Test (WDT) is a propaedeutic widely used to evaluate the maximum
      intraocular pressure (IOP) and its fluctuation. These data are extremely important for the
      expected result in relation to the reproducibility of the exams, since in the study , showed
      that the WDT can be used to estimate the peak and diurnal fluctuation of supine IOP in the
      simplified daily stress curve (another method for the same purpose of the WDT) in patients
      under treatment for glaucoma.

      Glaucoma is a serious eye health problem, as it has a high incidence and prevalence worldwide
      and is the leading cause of irreversible blindness in the world. Therefore, it is extremely
      important to perform tests that will detect altered IOP values.

      The IOP values obtained over a 24 hour period are important data, since they are required to
      control and conduct the treatment of glaucoma. In the past, the WDT has often been used to
      diagnose patients with this pathology. Due to a series of studies,it was found that the WDT
      can not be used as a diagnostic test, but as a tool to evaluate changes in IOP peaks. In
      addition, a comparison of reproducibility between devices will facilitate a better
      evaluation, speed, safety and efficacy in the treatment, contributing to increase the quality
      of life of the patient and also to guide other studies in this area.
observational model: Case-Only
time perspective: Retrospective
measure: Water drinking test and its reproducibility in Goldmann applanation tonometry
time frame: Six months
measure: Water drinking test and its reproducibility in pneumatic tonometry
time frame: Six months
arm group label: primary open-angle glaucoma and/or glaucoma suspects
description: Individuals with primary open-angle glaucoma and/or glaucoma suspects, selected from the electronic records of the VER Hospital. The following variables will be observed: gender, age, race, systemic diseases, intraocular pressure, type of glaucoma, complementary exams and degree of evolution. All patients were given a complete ophthalmologic examination, including Goldmann and pneumatic tonometry.
intervention type: Other
intervention name: Analysis of medical records
description: Individuals with primary open-angle glaucoma and/or glaucoma suspects, selected from the electronic records of the VER Hospital. The following variables will be observed: gender, age, race, systemic diseases, intraocular pressure, type of glaucoma, complementary exams and degree of evolution. All patients were given a complete ophthalmologic examination, including Goldmann and pneumatic tonometry.
arm group label: primary open-angle glaucoma and/or glaucoma suspects
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
citation: Wachtl J, Toteberg-Harms M, Frimmel S, Kniestedt C. [Evaluation of correction formulas for tonometry : The Goldmann applanation tonometry in approximation to dynamic contour tonometry]. Ophthalmologe. 2017 Aug;114(8):716-721. doi: 10.1007/s00347-016-0409-3. German.
PMID: 27921133
citation: Sakata R, Aihara M, Murata H, Saito H, Iwase A, Yasuda N, Araie M. Intraocular pressure change over a habitual 24-hour period after changing posture or drinking water and related factors in normal tension glaucoma. Invest Ophthalmol Vis Sci. 2013 Aug 7;54(8):5313-20. doi: 10.1167/iovs.13-11792.
PMID: 23821194
citation: Medina FM, Rodrigues FK, Filho Pde T, Matsuo T, Vasconcellos JP, Costa VP. Reproducibility of water drinking test performed at different times of the day. Arq Bras Oftalmol. 2009 May-Jun;72(3):283-90. doi: 10.1590/s0004-27492009000300002.
PMID: 19668954
citation: Meirelles SH, Yamane R, Alvares RM, Botelho PB, Morais FB, Moreira PB, Dantas AM, de Moraes Junior HV. [Comparative study between diurnal intraocular pressure curve and the association of ambulatory intraocular pressure curve with the water-drinking test in open angle glaucoma, normal tension glaucoma and normal eyes]. Arq Bras Oftalmol. 2007 May-Jun;70(3):471-9. doi: 10.1590/s0004-27492007000300015. Portuguese.
PMID: 17768555
citation: Medeiros FA, Sample PA, Zangwill LM, Bowd C, Aihara M, Weinreb RN. Corneal thickness as a risk factor for visual field loss in patients with preperimetric glaucomatous optic neuropathy. Am J Ophthalmol. 2003 Nov;136(5):805-13. doi: 10.1016/s0002-9394(03)00484-7.
PMID: 14597030
citation: Caiado RR, Badaro E, Kasahara N. Intraocular pressure fluctuation in healthy and glaucomatous eyes: a comparative analysis between diurnal curves in supine and sitting positions and the water drinking test. Arq Bras Oftalmol. 2014 Oct;77(5):288-292. doi: 10.5935/0004-2749.20140073. Epub 2014 Sep 1.
PMID: 25494373
citation: Regev G, Harris A, Siesky B, Shoshani Y, Egan P, Moss A, Zalish M, WuDunn D, Ehrlich R. Goldmann applanation tonometry and dynamic contour tonometry are not correlated with central corneal thickness in primary open angle glaucoma. J Glaucoma. 2011 Jun-Jul;20(5):282-6. doi: 10.1097/IJG.0b013e3181e66498.
PMID: 20577097
citation: Guler M, Bilak S, Bilgin B, Simsek A, Capkin M, Hakim Reyhan A. Comparison of Intraocular Pressure Measurements Obtained by Icare PRO Rebound Tonometer, Tomey FT-1000 Noncontact Tonometer, and Goldmann Applanation Tonometer in Healthy Subjects. J Glaucoma. 2015 Oct-Nov;24(8):613-8. doi: 10.1097/IJG.0000000000000132.
PMID: 25264986
citation: Quaranta L, Konstas AG, Rossetti L, Garcia-Feijoo J, O'Brien C, Nasr MB, Fogagnolo P, Demos CM, Stewart JA, Stewart WC. Untreated 24-h intraocular pressures measured with Goldmann applanation tonometry vs nighttime supine pressures with Perkins applanation tonometry. Eye (Lond). 2010 Jul;24(7):1252-8. doi: 10.1038/eye.2009.300. Epub 2009 Dec 4.
PMID: 19960033
responsible party type: Principal Investigator
investigator affiliation: VER Excelência em Oftalmologia
investigator full name: Rodrigo Egidio da Silva
investigator title: ophthalmologist
mesh term: Glaucoma
sharing ipd: No