Ignite Creation Date:
2024-05-06 @ 3:01 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04490876
Status:
COMPLETED
Last Update Posted:
2020-07-30
First Post:
2020-07-25
Brief Title:
Outcomes of Extensive Brilliant Blue G-Assisted Internal Limiting Membrane Peeling in Proliferative Vitreoretinopathy
Sponsor:
Centro Oftalmológico Dr Charles
Organization:
Centro Oftalmológico Dr Charles
Study Overview
Official Title:
Outcomes of Extensive Brilliant Blue G-Assisted Internal Limiting Membrane Peeling in Retinal Detachment With Proliferative Vitreoretinopathy Using 3D Visualization System
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ILM
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 141 months
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 141 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 wwwcomitedeeticaceiccomar 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 005 wv BBG solution OCUBLUE PLUS Aurolab approximately 03-05 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 87 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 andor total RD andor 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
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 005 wv BBG solution OCUBLUE PLUS Aurolab approximately 03-05 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 87 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 andor total RD andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None