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

Completed

• Conditions: Proliferative Vitreoretinopathy
• Interventions: Procedure: 3D Pars Plana Vitrectomy associated with Extensive Brilliant Blue G-Assisted ILM Peeling Method

• Registration Number: NCT04490876
• Lead Sponsor: Centro Oftalmológico Dr Charles

Brief Summary

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 ).

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 Timeline

• Status Verified: 2020-07
• Study Start: 2020-07-20
• Primary Completion: 2020-07-25
• Study Completion: 2020-07-25
• Study First Submitted: 2020-07-25
• Study First Submitted QC: 2020-07-25
• Last Update Submitted: 2020-07-28
• Study First Posted: 2020-07-29
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retinal Detachment with PVR	3D Pars Plana Vitrectomy associated with Extensive Brilliant Blue G-Assisted ILM Peeling Method	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.

Primary Outcome Measures

Name	Time	Method
Persistent retinal reattachment	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).

Secondary Outcome Measures

Name	Time	Method
Mean Best Corrected Visual Acuity	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.
Spectral Domain OPTICAL COHERENCE TOMOGRAPHY (SD-OCT) IMAGING of the MACULA	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.

Trial Locations

Locations (1)

Centro Oftalmologico Dr Charles; 🇦🇷 Buenos Aires, Capital Federal, Argentina