Evaluation of Vitrectomy With ILM Peeling in Myopic Macular Hole With Only Posterior Retinal Detachment

December 23, 2023 updated by: Ehab Tharwat, Al-Azhar University
Retinal detachment (RD) resulting from the macular hole (MH), also known as MH-induced RD (MHRD), most commonly occurs in eyes with high myopia and results in irreversible visual disorders. Although ILM peeling for MHRD reportedly achieves a high retinal reattachment rate that ranges from 70% to 100%, the MH closure rate is relatively low, ranging from 10% to 70%.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

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
    • New Damietta
      • Damieta, New Damietta, Egypt, 34517
        • Ehab tharwat

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with high myopia (a spherical equivalent refractive error of at least -6.0 diopters (D) and an axial length of at least 26.5 mm).
  • Macular hole and only posterior retinal detachment

Exclusion Criteria:

  • Other causes of RD
  • Patients with a history of trauma, choroidal neovascularization, coexistence with a peripheral retinal break or proliferative vitreoretinopathy
  • History of any vitreoretinal surgery prior to MHRD and less than 36 months of follow-up after the surgery

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: myopic eyes with macular hole and only posterior retinal detachment
Procedure: Vitrectomy with ILM peeling
Vitrectomy with traditional internal limiting membrane (ILM) peeling technique is regarded as the gold standard treatment for MH; it works by completely relieving of the traction of the macula and increasing the flexibility of the retina

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Closure of macular hole
Time Frame: 6 months post operative
It is a subjective outcome measured by Optical coherence tomography and by clinical slit lamb examination
6 months post operative
BCVA
Time Frame: baseline
It is a measure of the visual acuity, which will be measured by LogMar
baseline
BCVA
Time Frame: 6 months postoperative
It is a measure of the visual acuity, which will be measured by LogMar
6 months postoperative
BCVA
Time Frame: 12 months postoperative
It is a measure of the visual acuity, which will be measured by LogMar
12 months postoperative

Collaborators and Investigators

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

Sponsor

Al-Azhar University

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)

January 1, 2022

Primary Completion (Actual)

December 1, 2023

Study Completion (Estimated)

January 15, 2024

Study Registration Dates

First Submitted

December 23, 2023

First Submitted That Met QC Criteria

December 23, 2023

First Posted (Estimated)

January 8, 2024

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

December 23, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vitrectomy with ILM peeling

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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