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

NCT07633457 | Recruiting

• 1 other identifier: FMASU MD351/2025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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; Tenon Capsule; ILM Flap; Macular Hole; ILM Peeling

Keywords

Macular hole; ILM flap; Tenon capsule; Graft

Outcome Measures

Primary Outcomes (1)

• -Improvement in best corrected visual acuity (BCVA)

  Improvement in BCVA measured by snellen E chart then transformation to Logarithm of the minimum angle of resolution (Log MAR)

  3 months postoperative

Secondary Outcomes (2)

• OCT

  3 months postoperative

• OCTA

  3 months

Study Arms (2)

ILM flap

OTHER

ILM flap for treatment of macular hole as control

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

Tenon capsule graft

ACTIVE COMPARATOR

Tenon capsule graft for treatment of macular hole

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

Interventions

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

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

Also known as: Ilm flap, Tenon capsule graft

ILM flap; Tenon capsule graft

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with idiopathic full-thickness macular hole
• ≥400 µm in horizontal diameter

You may not qualify if:

• Media opacity preventing adequate OCT/OCTA imaging
• Other retinal vascular pathology as retinal vascular occlusion
• Intraoperative complications
• Signal noise ratio using OCTA \<6\\10
• Poor fixation of the patient

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbassia, Egypt

RECRUITING

MeSH Terms

Conditions

Retinal Perforations

Interventions

proxymetacaine; Transplantation

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Khaled Nehad Elsherief

CONTACT

0201225602369; khalednehad0100209@med.asu.edu.eg

Mohammad Ahmed Rashad

CONTACT

+20 111 575 8888

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: June 8, 2026
• Study Start: November 9, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-03

Locations

EG (1)