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Evaluation of Visual Functions After Pars Plana Vitrectomy With and Without Internal Limiting Membrane Peeling in RRD

Primary Purpose

Retinal Detachment

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pars Plana Vitrectomy
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Detachment focused on measuring Internal limiting membrane, multifocal electoretinogram (ERG), OCT-Angiography

Eligibility Criteria

20 Years - 73 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All eyes with recent macula-off rhegmatogenous retinal detachment (RRD).

Exclusion Criteria:

  • Complicated cases with advanced proliferative vitreoretinopathy (PVR).
  • Patients with retinal vascular disorders and other macular disorders.
  • Combined tractional and rhegmatogenous detachment.
  • Previous retinal reattachment surgery or Intravitreal injections.
  • Glaucomatous patients.
  • Patients with corneal opacity which impairs good visualization.

Sites / Locations

  • Minia UNiversity hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

non-ILM peeling group

ILM peeling group

Arm Description

vitrectomy without ILM peeling is done to all cases

vitrectomy with ILM peeling is done to all cases

Outcomes

Primary Outcome Measures

anatomical outcome
Rate of retinal reattachment using indirect ophthalmoscopy
epiretinal membrane
incidence rate of epiretinal membrane formation after surgery in % percent

Secondary Outcome Measures

functional outcome
visual functions using log Mar Best Corrected Visual Acuity (BCVA)
superficial capillary density
measurement of percent (%) of superficial and deep capillary density using Optical Coherance Tomography Angiography
multi-focal Electroretinogram
measurement of P1 amplitude

Full Information

First Posted
September 24, 2019
Last Updated
October 23, 2019
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT04139811
Brief Title
Evaluation of Visual Functions After Pars Plana Vitrectomy With and Without Internal Limiting Membrane Peeling in RRD
Official Title
Evaluation of Primary Internal Limiting Membrane Peeling in Cases of Rhegmatogenous Retinal Detachment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
August 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Internal limiting membrane peeling is performed during vitrectomy for macular diseases such as macular holes, macular edema due to diabetic retinopathy and retinal vein occlusion. The incidence of epiretinal membrane formation after vitrectomy for rhegmatogenous detachment has been reported to range from 4.4% to 12.8%. In this study, the efficacy and safety of internal limiting membrane peeling will be studied in vitrectomy for rhegmatogenous retinal detachment and if it is essential to peel it in those cases or not.
Detailed Description
interventional observational study comparing vitrectomy with versus without internal limiting membrane peeling in cases of rhegmatogenous retinal detachment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment
Keywords
Internal limiting membrane, multifocal electoretinogram (ERG), OCT-Angiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
non-ILM peeling group
Arm Type
Other
Arm Description
vitrectomy without ILM peeling is done to all cases
Arm Title
ILM peeling group
Arm Type
Other
Arm Description
vitrectomy with ILM peeling is done to all cases
Intervention Type
Other
Intervention Name(s)
Pars Plana Vitrectomy
Intervention Description
vitrectomy with and without ILM peeling
Primary Outcome Measure Information:
Title
anatomical outcome
Description
Rate of retinal reattachment using indirect ophthalmoscopy
Time Frame
6 months follow up
Title
epiretinal membrane
Description
incidence rate of epiretinal membrane formation after surgery in % percent
Time Frame
6 months follow up
Secondary Outcome Measure Information:
Title
functional outcome
Description
visual functions using log Mar Best Corrected Visual Acuity (BCVA)
Time Frame
6 months follow up
Title
superficial capillary density
Description
measurement of percent (%) of superficial and deep capillary density using Optical Coherance Tomography Angiography
Time Frame
6 months follow up
Title
multi-focal Electroretinogram
Description
measurement of P1 amplitude
Time Frame
6 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All eyes with recent macula-off rhegmatogenous retinal detachment (RRD). Exclusion Criteria: Complicated cases with advanced proliferative vitreoretinopathy (PVR). Patients with retinal vascular disorders and other macular disorders. Combined tractional and rhegmatogenous detachment. Previous retinal reattachment surgery or Intravitreal injections. Glaucomatous patients. Patients with corneal opacity which impairs good visualization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed F Othman, MD
Organizational Affiliation
sub-investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed Shawkat, MD
Organizational Affiliation
sub-investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
khalid Murad
Organizational Affiliation
sub-investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed Abdullah
Organizational Affiliation
sub-investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minia UNiversity hospital
City
Minya
State/Province
Minia
ZIP/Postal Code
61111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32411388
Citation
Abdullah ME, Moharram HEM, Abdelhalim AS, Mourad KM, Abdelkader MF. Evaluation of primary internal limiting membrane peeling in cases with rhegmatogenous retinal detachment. Int J Retina Vitreous. 2020 May 7;6:8. doi: 10.1186/s40942-020-00213-4. eCollection 2020.
Results Reference
derived

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Evaluation of Visual Functions After Pars Plana Vitrectomy With and Without Internal Limiting Membrane Peeling in RRD

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