<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/NCT04490876</url>
  </required_header>
  <id_info>
    <org_study_id>3701001</org_study_id>
    <nct_id>NCT04490876</nct_id>
  </id_info>
  <brief_title>Outcomes of Extensive Brilliant Blue G-Assisted Internal Limiting Membrane Peeling in Proliferative Vitreoretinopathy</brief_title>
  <acronym>ILM</acronym>
  <official_title>Outcomes of Extensive Brilliant Blue G-Assisted Internal Limiting Membrane Peeling in Retinal Detachment With Proliferative Vitreoretinopathy Using 3D Visualization System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Oftalmológico Dr Charles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centro Oftalmológico Dr Charles</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 is to report outcomes of pars plana vitrectomy (PPV) in retinal&#xD;
      detachment (RD) accompanied with proliferative vitreoretinopathy (PVR) after extensive&#xD;
      Brilliant Blue G-Assisted internal limiting membrane (ILM) peeling using a 3D visualization&#xD;
      system.&#xD;
&#xD;
      This is retrospective consecutive case series of 14 eyes treated with PPV for RD repair. The&#xD;
      patients were follow for 7 to 47 months (mean follow-up: 14.1 months ).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is the retrospective study of 14 consecutive patients suffering from retinal detachment&#xD;
      with proliferative vitreoretinopathy who underwent primary PPV at the Department of Retina of&#xD;
      Centro Oftalmologico Dr Charles, Buenos Aires-Argentina between January 1, 2016 and August 1,&#xD;
      2020 . This study followed the tenets of the Declaration of Helsinki and it was approved by&#xD;
      the approved by the research ethics committee (www.comitedeeticaceic.com.ar). Written&#xD;
      informed consent was taken from all subjects. All cases were performed by a single&#xD;
      experienced vitreoretinal surgeon (MCH)&#xD;
&#xD;
      The treatment chosen in the study was pars plana vitrectomy with Brilliant Blue G (BBG)&#xD;
      staining using the Ngenuity 3D Visualization System (Alcon). We spread 0.05% w/v BBG solution&#xD;
      (OCUBLUE PLUS, Aurolab), approximately 0.3-0.5 ml, on the retinal surface and peeled off the&#xD;
      ILM from the posterior pole up to the periphery, thus ensuring the total removal of the&#xD;
      overlying epiretinal membranes responsible for recurrent detachment. Frequent restaining with&#xD;
      BBG helped revealing new edges and perfluorocarbon liquid was used in others to stabilize the&#xD;
      retina (Figure1). ).. All patients underwent vitreoretinal surgery due to RD (rhegmatogenous,&#xD;
      tractional or combined rhegmatogenous and tractional). Exclusion criteria from the study was&#xD;
      the time of follow-up less than 6 months.&#xD;
&#xD;
      Average age at the time of the presence of RD was 56 ± 8.7 years (range 23-77 years). Pre-&#xD;
      and postoperative data were collected. Descriptive statistical analysis included gender, age&#xD;
      at the presentation, laterality, etiology, duration of presenting symptoms, presences of&#xD;
      ocular comorbidities, macular status (attached or non-attached), presence of PVR (preretinal,&#xD;
      subretinal and intraretinal) initial and final best-corrected visual acuity (BCVA), number of&#xD;
      procedures, type of endotamponade during PPV, final lens status, duration of the follow-up,&#xD;
      anatomical success and complications. Indications for PPV were as follows: presence of&#xD;
      advanced PVR and/or total RD and/or multiple breaks, giant retinal tears. PVR was graded&#xD;
      according to the Retina Society Terminology Classification and anatomical location&#xD;
      (references). Visual acuity was measured by Snellen charts. The anatomical success was&#xD;
      defined as persistent retinal reattachment at the last follow-up visit (in absence of&#xD;
      silicone oil tamponade).&#xD;
&#xD;
      Statistical computations were performed using STATA 16 data analysis and statistical software&#xD;
      (StataCorp LLC, College Station, Texas, USA)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">July 25, 2020</completion_date>
  <primary_completion_date type="Actual">July 25, 2020</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>Persistent retinal reattachment</measure>
    <time_frame>6 months after silicone oil removal</time_frame>
    <description>The anatomical success was defined as persistent retinal reattachment at the last follow-up visit (in absence of silicone oil tamponade).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Best Corrected Visual Acuity</measure>
    <time_frame>mean follow-up: 14.1 months</time_frame>
    <description>BCVA was recorded at each visit, reported in Snellen fraction and converted into logarithm of the minimal angle of resolution (logMAR) values for statistical analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spectral Domain OPTICAL COHERENCE TOMOGRAPHY (SD-OCT) IMAGING of the MACULA</measure>
    <time_frame>mean follow-up: 14.1 months</time_frame>
    <description>SD-OCT images were obtained with the Spectralis OCT with eye-tracking dual-beam technology (Heidelberg Engineering GmbH, Heidelberg, Germany) and reviewed with the Heidelberg Eye Explorer (version 1.8.6.0) using the HRA/Spectralis Viewing Module (version 5.8.3.0). All patients underwent the Sequential 12-line radial scans and were evaluated for the presence of intraretinal/subretinal fluid. Mean central foveal thickness was obtained with the automated ''thickness map'' function of the Heidelberg Eye Explorer.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">14</enrollment>
  <condition>Proliferative Vitreoretinopathy</condition>
  <arm_group>
    <arm_group_label>Retinal Detachment with PVR</arm_group_label>
    <description>Proliferative vitreoretinopathy (PVR), a major complication of rhegmatogenous retinal detachment (RRD), is an abnormal process whereby proliferative, contractile cellular membranes form in the vitreous and on both sides of the retina, resulting in tractional retinal detachment with fixed retinal folds. Patients with RD complicated by PVR will be included, and the proposed intervention will be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>3D Pars Plana Vitrectomy associated with Extensive Brilliant Blue G-Assisted ILM Peeling Method</intervention_name>
    <description>After the injection of Brilliant Blue-G (BBG) into the vitreous cavity, the epiretinal membrane (ERM) with cellular proliferation on the surface of the retina did not stain clearly, while the internal limiting membranes did stain clearly. We peeled off the internal limiting membrane (ILM) underlying the ERM using the ILM forceps for the macular area and the serrated forceps for the remaining ILM beyond the vascular arcades (Grieshaber, Alcon Laboratories, Inc., Fort Worth, Texas (Figure1) and enhanced membrane viewing with filters on the Ngenuity system. Restaining with BBG was needed and perfluorocarbon liquid PFCL was injected with a coaxial Dual Bore cannula (MedOne) to flatten the retina.</description>
    <arm_group_label>Retinal Detachment with PVR</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Private retina clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients older than 18 years age suffering from retinal detachment with proliferative&#xD;
             vitreoretinopathy who underwent primary PPV at the Department of Retina of Centro&#xD;
             Oftalmologico Dr Charles, Buenos Aires-Argentina between January 1, 2016 and August 1,&#xD;
             2020 .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients younger than 18 years age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centro Oftalmologico Dr Charles</name>
      <address>
        <city>Buenos Aires</city>
        <state>Capital Federal</state>
        <zip>1116</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <results_reference>
    <citation>Foveau P, Leroy B, Berrod JP, Conart JB. Internal Limiting Membrane Peeling in Macula-off Retinal Detachment Complicated by Grade B Proliferative Vitreoretinopathy. Am J Ophthalmol. 2018 Jul;191:1-6. doi: 10.1016/j.ajo.2018.03.037. Epub 2018 Apr 3.</citation>
    <PMID>29621507</PMID>
  </results_reference>
  <results_reference>
    <citation>Odrobina DC, Michalewska Z, Michalewski J, Nawrocki J. High-speed, high-resolution spectral optical coherence tomography in patients after vitrectomy with internal limiting membrane peeling for proliferative vitreoretinopathy retinal detachment. Retina. 2010 Jun;30(6):881-6. doi: 10.1097/IAE.0b013e3181c96952.</citation>
    <PMID>20182404</PMID>
  </results_reference>
  <results_reference>
    <citation>Sakamoto H, Yamanaka I, Kubota T, Ishibashi T. Indocyanine green-assisted peeling of the epiretinal membrane in proliferative vitreoretinopathy. Graefes Arch Clin Exp Ophthalmol. 2003 Mar;241(3):204-7. doi: 10.1007/s00417-002-0601-9. Epub 2003 Feb 20.</citation>
    <PMID>12644944</PMID>
  </results_reference>
  <results_reference>
    <citation>Aras C, Arici C, Akar S, Muftuoglu G, Yolar M, Arvas S, Baserer T, Koyluoglu N. Peeling of internal limiting membrane during vitrectomy for complicated retinal detachment prevents epimacular membrane formation. Graefes Arch Clin Exp Ophthalmol. 2009 May;247(5):619-23. doi: 10.1007/s00417-008-1025-y. Epub 2008 Dec 24.</citation>
    <PMID>19107502</PMID>
  </results_reference>
  <results_reference>
    <citation>Enaida H, Hisatomi T, Hata Y, Ueno A, Goto Y, Yamada T, Kubota T, Ishibashi T. Brilliant blue G selectively stains the internal limiting membrane/brilliant blue G-assisted membrane peeling. Retina. 2006 Jul-Aug;26(6):631-6. doi: 10.1097/01.iae.0000236469.71443.aa.</citation>
    <PMID>16829804</PMID>
  </results_reference>
  <results_reference>
    <citation>Kumar A, Hasan N, Kakkar P, Mutha V, Karthikeya R, Sundar D, Ravani R. Comparison of clinical outcomes between &quot;heads-up&quot; 3D viewing system and conventional microscope in macular hole surgeries: A pilot study. Indian J Ophthalmol. 2018 Dec;66(12):1816-1819. doi: 10.4103/ijo.IJO_59_18.</citation>
    <PMID>30451186</PMID>
  </results_reference>
  <results_reference>
    <citation>Lai CT, Kung WH, Lin CJ, Chen HS, Bair H, Lin JM, Chen WL, Tien PT, Tsai YY. Outcome of primary rhegmatogenous retinal detachment using microincision vitrectomy and sutureless wide-angle viewing systems. BMC Ophthalmol. 2019 Nov 19;19(1):230. doi: 10.1186/s12886-019-1238-3.</citation>
    <PMID>31744475</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centro Oftalmológico Dr Charles</investigator_affiliation>
    <investigator_full_name>Anibal Andres Francone</investigator_full_name>
    <investigator_title>Medical Doctor. Ophthalmologist Board Certificate. Fellowship in Vitreoretinal Diseases.</investigator_title>
  </responsible_party>
  <keyword>Retinal Detachment</keyword>
  <keyword>Proliferative Vitreoretinopathy</keyword>
  <keyword>Internal Limiting Membrane</keyword>
  <keyword>ILM peeling</keyword>
  <keyword>Brilliant Blue G</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Detachment</mesh_term>
    <mesh_term>Vitreoretinopathy, Proliferative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04490876
org study id: 3701001
nct id: NCT04490876
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to report outcomes of pars plana vitrectomy (PPV) in retinal
      detachment (RD) accompanied with proliferative vitreoretinopathy (PVR) after extensive
      Brilliant Blue G-Assisted internal limiting membrane (ILM) peeling using a 3D visualization
      system.

      This is retrospective consecutive case series of 14 eyes treated with PPV for RD repair. The
      patients were follow for 7 to 47 months (mean follow-up: 14.1 months ).
This is the retrospective study of 14 consecutive patients suffering from retinal detachment
      with proliferative vitreoretinopathy who underwent primary PPV at the Department of Retina of
      Centro Oftalmologico Dr Charles, Buenos Aires-Argentina between January 1, 2016 and August 1,
      2020 . This study followed the tenets of the Declaration of Helsinki and it was approved by
      the approved by the research ethics committee (www.comitedeeticaceic.com.ar). Written
      informed consent was taken from all subjects. All cases were performed by a single
      experienced vitreoretinal surgeon (MCH)

      The treatment chosen in the study was pars plana vitrectomy with Brilliant Blue G (BBG)
      staining using the Ngenuity 3D Visualization System (Alcon). We spread 0.05% w/v BBG solution
      (OCUBLUE PLUS, Aurolab), approximately 0.3-0.5 ml, on the retinal surface and peeled off the
      ILM from the posterior pole up to the periphery, thus ensuring the total removal of the
      overlying epiretinal membranes responsible for recurrent detachment. Frequent restaining with
      BBG helped revealing new edges and perfluorocarbon liquid was used in others to stabilize the
      retina (Figure1). ).. All patients underwent vitreoretinal surgery due to RD (rhegmatogenous,
      tractional or combined rhegmatogenous and tractional). Exclusion criteria from the study was
      the time of follow-up less than 6 months.

      Average age at the time of the presence of RD was 56 ± 8.7 years (range 23-77 years). Pre-
      and postoperative data were collected. Descriptive statistical analysis included gender, age
      at the presentation, laterality, etiology, duration of presenting symptoms, presences of
      ocular comorbidities, macular status (attached or non-attached), presence of PVR (preretinal,
      subretinal and intraretinal) initial and final best-corrected visual acuity (BCVA), number of
      procedures, type of endotamponade during PPV, final lens status, duration of the follow-up,
      anatomical success and complications. Indications for PPV were as follows: presence of
      advanced PVR and/or total RD and/or multiple breaks, giant retinal tears. PVR was graded
      according to the Retina Society Terminology Classification and anatomical location
      (references). Visual acuity was measured by Snellen charts. The anatomical success was
      defined as persistent retinal reattachment at the last follow-up visit (in absence of
      silicone oil tamponade).

      Statistical computations were performed using STATA 16 data analysis and statistical software
      (StataCorp LLC, College Station, Texas, USA)
observational model: Case-Only
time perspective: Retrospective
measure: Persistent retinal reattachment
time frame: 6 months after silicone oil removal
description: The anatomical success was defined as persistent retinal reattachment at the last follow-up visit (in absence of silicone oil tamponade).
measure: Mean Best Corrected Visual Acuity
time frame: mean follow-up: 14.1 months
description: BCVA was recorded at each visit, reported in Snellen fraction and converted into logarithm of the minimal angle of resolution (logMAR) values for statistical analysis.
measure: Spectral Domain OPTICAL COHERENCE TOMOGRAPHY (SD-OCT) IMAGING of the MACULA
time frame: mean follow-up: 14.1 months
description: SD-OCT images were obtained with the Spectralis OCT with eye-tracking dual-beam technology (Heidelberg Engineering GmbH, Heidelberg, Germany) and reviewed with the Heidelberg Eye Explorer (version 1.8.6.0) using the HRA/Spectralis Viewing Module (version 5.8.3.0). All patients underwent the Sequential 12-line radial scans and were evaluated for the presence of intraretinal/subretinal fluid. Mean central foveal thickness was obtained with the automated ''thickness map'' function of the Heidelberg Eye Explorer.
arm group label: Retinal Detachment with PVR
description: Proliferative vitreoretinopathy (PVR), a major complication of rhegmatogenous retinal detachment (RRD), is an abnormal process whereby proliferative, contractile cellular membranes form in the vitreous and on both sides of the retina, resulting in tractional retinal detachment with fixed retinal folds. Patients with RD complicated by PVR will be included, and the proposed intervention will be performed.
intervention type: Procedure
intervention name: 3D Pars Plana Vitrectomy associated with Extensive Brilliant Blue G-Assisted ILM Peeling Method
description: After the injection of Brilliant Blue-G (BBG) into the vitreous cavity, the epiretinal membrane (ERM) with cellular proliferation on the surface of the retina did not stain clearly, while the internal limiting membranes did stain clearly. We peeled off the internal limiting membrane (ILM) underlying the ERM using the ILM forceps for the macular area and the serrated forceps for the remaining ILM beyond the vascular arcades (Grieshaber, Alcon Laboratories, Inc., Fort Worth, Texas (Figure1) and enhanced membrane viewing with filters on the Ngenuity system. Restaining with BBG was needed and perfluorocarbon liquid PFCL was injected with a coaxial Dual Bore cannula (MedOne) to flatten the retina.
arm group label: Retinal Detachment with PVR
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Argentina
citation: Foveau P, Leroy B, Berrod JP, Conart JB. Internal Limiting Membrane Peeling in Macula-off Retinal Detachment Complicated by Grade B Proliferative Vitreoretinopathy. Am J Ophthalmol. 2018 Jul;191:1-6. doi: 10.1016/j.ajo.2018.03.037. Epub 2018 Apr 3.
PMID: 29621507
citation: Odrobina DC, Michalewska Z, Michalewski J, Nawrocki J. High-speed, high-resolution spectral optical coherence tomography in patients after vitrectomy with internal limiting membrane peeling for proliferative vitreoretinopathy retinal detachment. Retina. 2010 Jun;30(6):881-6. doi: 10.1097/IAE.0b013e3181c96952.
PMID: 20182404
citation: Sakamoto H, Yamanaka I, Kubota T, Ishibashi T. Indocyanine green-assisted peeling of the epiretinal membrane in proliferative vitreoretinopathy. Graefes Arch Clin Exp Ophthalmol. 2003 Mar;241(3):204-7. doi: 10.1007/s00417-002-0601-9. Epub 2003 Feb 20.
PMID: 12644944
citation: Aras C, Arici C, Akar S, Muftuoglu G, Yolar M, Arvas S, Baserer T, Koyluoglu N. Peeling of internal limiting membrane during vitrectomy for complicated retinal detachment prevents epimacular membrane formation. Graefes Arch Clin Exp Ophthalmol. 2009 May;247(5):619-23. doi: 10.1007/s00417-008-1025-y. Epub 2008 Dec 24.
PMID: 19107502
citation: Enaida H, Hisatomi T, Hata Y, Ueno A, Goto Y, Yamada T, Kubota T, Ishibashi T. Brilliant blue G selectively stains the internal limiting membrane/brilliant blue G-assisted membrane peeling. Retina. 2006 Jul-Aug;26(6):631-6. doi: 10.1097/01.iae.0000236469.71443.aa.
PMID: 16829804
citation: Kumar A, Hasan N, Kakkar P, Mutha V, Karthikeya R, Sundar D, Ravani R. Comparison of clinical outcomes between "heads-up" 3D viewing system and conventional microscope in macular hole surgeries: A pilot study. Indian J Ophthalmol. 2018 Dec;66(12):1816-1819. doi: 10.4103/ijo.IJO_59_18.
PMID: 30451186
citation: Lai CT, Kung WH, Lin CJ, Chen HS, Bair H, Lin JM, Chen WL, Tien PT, Tsai YY. Outcome of primary rhegmatogenous retinal detachment using microincision vitrectomy and sutureless wide-angle viewing systems. BMC Ophthalmol. 2019 Nov 19;19(1):230. doi: 10.1186/s12886-019-1238-3.
PMID: 31744475
responsible party type: Principal Investigator
investigator affiliation: Centro Oftalmológico Dr Charles
investigator full name: Anibal Andres Francone
investigator title: Medical Doctor. Ophthalmologist Board Certificate. Fellowship in Vitreoretinal Diseases.
mesh term: Retinal Detachment
mesh term: Vitreoretinopathy, Proliferative
sharing ipd: Undecided