NCT04490876

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 14 (actual)
• Sponsor: Centro Oftalmológico Dr Charles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Proliferative Vitreoretinopathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-07-20
• Primary completion: 2020-07-25
• Completion: 2020-07-25
• First posted: 2020-07-29
• Last updated: 2020-07-30

Locations

1 site across 1 country: Argentina