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

October 23, 2019 updated by: Hossam Mohamed Moharram, Minia University

Evaluation of Primary Internal Limiting Membrane Peeling in Cases of Rhegmatogenous Retinal Detachment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

interventional observational study comparing vitrectomy with versus without internal limiting membrane peeling in cases of rhegmatogenous retinal detachment.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Minia
      • Minya, Minia, Egypt, 61111
        • Minia University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: non-ILM peeling group
vitrectomy without ILM peeling is done to all cases
Other: Pars Plana Vitrectomy
vitrectomy with and without ILM peeling
Other: ILM peeling group
vitrectomy with ILM peeling is done to all cases
Other: Pars Plana Vitrectomy
vitrectomy with and without ILM peeling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anatomical outcome
Time Frame: 6 months follow up
Rate of retinal reattachment using indirect ophthalmoscopy
6 months follow up
epiretinal membrane
Time Frame: 6 months follow up
incidence rate of epiretinal membrane formation after surgery in % percent
6 months follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional outcome
Time Frame: 6 months follow up
visual functions using log Mar Best Corrected Visual Acuity (BCVA)
6 months follow up
superficial capillary density
Time Frame: 6 months follow up
measurement of percent (%) of superficial and deep capillary density using Optical Coherance Tomography Angiography
6 months follow up
multi-focal Electroretinogram
Time Frame: 6 months follow up
measurement of P1 amplitude
6 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Principal Investigator: Mohamed F Othman, MD, Sub-investigator
  • Principal Investigator: Ahmed Shawkat, MD, Sub-investigator
  • Principal Investigator: khalid Murad, Sub-investigator
  • Principal Investigator: Mohamed Abdullah, Sub-investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2017

Primary Completion (Actual)

July 15, 2019

Study Completion (Actual)

August 15, 2019

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

October 23, 2019

First Posted (Actual)

October 25, 2019

Study Record Updates

Last Update Posted (Actual)

October 25, 2019

Last Update Submitted That Met QC Criteria

October 23, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 66-7/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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