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Comparison Between Outcomes of Closure of Idiopathic Macular Hole Using Autologus Tenon Capsule Graft and Internal Limiting Membrane Flap Techniques (Pilot Study)

NCT07633457 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-06-08

No results posted yet for this study

Summary

The aim of this study is to compare the functional visual outcomes, anatomical closure rate and macular perfusion changes assessed by OCT and OCTA after surgical repair of macular hole using Tenon capsule graft versus ILM flap.

Conditions

  • Macular Hole Surgery
  • ILM Peeling
  • Tenon Capsule
  • ILM Flap
  • Macular Hole

Interventions

PROCEDURE

vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)]

Prospective interventional study In all patients (Group A \& B), PPV will be performed using a 23-gauge, transconjunctival, microincision vitrectomy system. Diluted triamcinolone acetonide (40 mg/ml) will be used to visualize the vitreous. After core vitrectomy, posterior hyaloid detachment will be attempted with the vitrectomy cutter in the suction mode. Then, the ILM will be stained using 0.05% Brilliant Blue G (OCUBLUE PLUS, India). In Group A: tenon capsule graft will be attempted In Group B: free flap ILM peeling will be attempted SF6 gas will be used as tamponade in both groups More than one vitreoretinal surgeon will participate

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-09
Primary Completion
2027-12-01
Completion
2028-01-01

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 NCT07633457 on ClinicalTrials.gov