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Macular Micro Vascular Changes Following Macular Hole Repair : Optical Coherence Tomography Angiography Study

NCT06233500 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-01-31

No results posted yet for this study

Summary

The goal of this prospective interventional study is to to compare the micro vascular and structural changes between surgery with and without ILM flap to repair macular hole.

The main questions it aims to answer are:

* What are the macular micro vascular and structural changes pre and post repair of idiopathic full thickness macular hole and what is the correlation between these changes and visual recovery.
* Is there are any prognostic values of the micro vascular status of the macula could be assessed preoperatively.
* What are the differences regarding these micro vascular and structural changes between repair with and without ILM flap.

Participants will be:

* Subjected to pars plana vitrectomy to repair macular hole.
* Examined by optical coherence tomography angiography pre and post operative

Researchers will compare:

Group A: eyes treated without ILM flap Group B : eyes treated by ILM flap to see if there are differences regarding the micro vascular and structural changes in the macular area.

Conditions

  • Macular Holes

Interventions

PROCEDURE

pars plana vitrectomy

All eyes in this study will be subjected to pars plana vitrectomy procedure with these main steps: * 23 G trocar system will be used * Posterior vitreous detachment will be induced with the aid of triamcinolone acetate injection, and core vitrectomy will be done * Brilliant blue stain will be injected, and ILM forceps will be used for ILM peeling Patients will be divided then into two groups: Group A: Only wide ILM peeling up to the arcades well be done Group B: ILM peeling with flap well be done * Shaving of the vitreous base, and then fluid air exchange * SF 6 gas tamponade will be used

Sponsors & Collaborators

  • Research Institute of Ophthalmology, Egypt

    collaborator OTHER

  • Fayoum University

    lead OTHER

Principal Investigators

  • Islam Mohalhal, MD · Research Institute of Ophthalmology, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2024-03-01
Completion
2024-03-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06233500 on ClinicalTrials.gov