Clinical trial NCT04490876: Outcomes of Extensive Brilliant Blue G-Assisted Internal Limiting Membrane Peeling in Proliferative Vitreoretinopathy
Official title: Outcomes of Extensive Brilliant Blue G-Assisted Internal Limiting Membrane Peeling in Retinal Detachment With Proliferative Vitreoretinopathy Using 3D Visualization System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proliferative Vitreoretinopathy
Keywords: Retinal Detachment
Proliferative Vitreoretinopathy
Internal Limiting Membrane
ILM peeling
Brilliant Blue G
Lead sponsor: Centro Oftalmológico Dr Charles
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Private retina clinic.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Persistent retinal reattachment
timeFrame: 6 months after silicone oil removal
Secondary outcomes:
measure: Mean Best Corrected Visual Acuity
timeFrame: mean follow-up: 14.1 months
measure: Spectral Domain OPTICAL COHERENCE TOMOGRAPHY (SD-OCT) IMAGING of the MACULA
timeFrame: mean follow-up: 14.1 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Centro Oftalmologico Dr Charles
state: Capital Federal
Study officials:
References:
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