Outcomes of Extensive Brilliant Blue G-Assisted Internal Limiting Membrane Peeling in Proliferative Vitreoretinopathy (ILM)

July 28, 2020 updated by: Anibal Andres Francone, Centro Oftalmológico Dr Charles

Outcomes of Extensive Brilliant Blue G-Assisted Internal Limiting Membrane Peeling in Retinal Detachment With Proliferative Vitreoretinopathy Using 3D Visualization System

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 ).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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)

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Capital Federal
      • Buenos Aires, Capital Federal, Argentina, 1116
        • Centro Oftalmologico Dr Charles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Private retina clinic.

Description

Inclusion Criteria:

  • patients older than 18 years age 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 .

Exclusion Criteria:

  • patients younger than 18 years age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retinal Detachment with PVR
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.
Procedure: 3D Pars Plana Vitrectomy associated with Extensive Brilliant Blue G-Assisted ILM Peeling Method
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistent retinal reattachment
Time Frame: 6 months after silicone oil removal
The anatomical success was defined as persistent retinal reattachment at the last follow-up visit (in absence of silicone oil tamponade).
6 months after silicone oil removal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Best Corrected Visual Acuity
Time Frame: mean follow-up: 14.1 months
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.
mean follow-up: 14.1 months
Spectral Domain OPTICAL COHERENCE TOMOGRAPHY (SD-OCT) IMAGING of the MACULA
Time Frame: mean follow-up: 14.1 months
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.
mean follow-up: 14.1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Oftalmológico Dr Charles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2020

Primary Completion (Actual)

July 25, 2020

Study Completion (Actual)

July 25, 2020

Study Registration Dates

First Submitted

July 25, 2020

First Submitted That Met QC Criteria

July 25, 2020

First Posted (Actual)

July 29, 2020

Study Record Updates

Last Update Posted (Actual)

July 30, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3701001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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