Ignite Creation Date:
2024-05-06 @ 10:16 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03208205
Status:
COMPLETED
Last Update Posted:
2017-07-05
First Post:
2017-06-01
Brief Title:
Outcomes of Vitrectomy in Pediatric Retinal Detachment With Proliferative Vitreoretinopathy
Sponsor:
Medical University of Lublin
Organization:
Medical University of Lublin
Study Overview
Official Title:
Outcomes of Vitrectomy in Pediatric Retinal Detachment With Proliferative Vitreoretinopathy
Status:
COMPLETED
Status Verified Date:
2017-07
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:
None
Brief Summary:
The aim of this study is to report outcomes of pars plana vitrectomy PPV in pediatric retinal detachment RD accompanied with proliferative vitreoretinopathy PVR as well as complications and factors influencing the final anatomical and functional results
This is retrospective consecutive case series of 14 eyes treated with primary PPV for RD repair Average postoperative follow-up period is 34 months
This is retrospective consecutive case series of 14 eyes treated with primary PPV for RD repair Average postoperative follow-up period is 34 months
Detailed Description:
This is the retrospective study of 14 consecutive patients younger than 18 years age who underwent primary PPV at the Department of General Ophthalmology of Medical University of Lublin in a time period from 1st January 2006 to 1st January 2017 This study followed the tenets of the Declaration of Helsinki The treatment chosen in the study was a part of a standard care Written informed consent was taken from all subjects 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 1047 years range 4-17 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 grade C 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 9 Visual acuity was measured by Snellen charts The anatomical success was defined as persistent retinal reattachment at the last follow-up visit regardless of presence or absence of silicone oil tamponade
Statistical computations were performed using STATISTICA 13PL Stasoft USA programme
Average age at the time of the presence of RD was 1047 years range 4-17 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 grade C 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 9 Visual acuity was measured by Snellen charts The anatomical success was defined as persistent retinal reattachment at the last follow-up visit regardless of presence or absence of silicone oil tamponade
Statistical computations were performed using STATISTICA 13PL Stasoft USA programme
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