Actively Recruiting

Phase Not Applicable
All Genders
ID07633457

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

Led by Ain Shams University · Updated on 2026-06-08

20

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare two surgical techniques for repairing idiopathic full-thickness macular holes, which cause central vision loss due to a defect in the retina. The study evaluates functional vision outcomes, anatomical closure rates, and changes in macular blood flow measured by advanced imaging methods called OCT and OCTA. It focuses on large macular holes, which are more common with age and often affect females, and addresses the need to find better repair methods for challenging cases. Participants will undergo one of two treatments: surgical repair using either a Tenon capsule graft or an internal limiting membrane (ILM) flap. Both procedures involve vitrectomy performed with a specialized small-gauge system and use of a gas tamponade to support healing. The Tenon capsule graft uses biological tissue rich in cells that may aid repair, while the ILM flap technique involves repositioning retinal tissue to promote closure. Multiple surgeons will perform these operations, and patients will be divided randomly into these two groups. Participants will have thorough eye exams before surgery and then follow-up visits one day and three months after the procedure. These visits include vision tests, eye pressure measurements, and detailed imaging of the retina and its blood vessels using OCT and OCTA. Researchers will analyze visual acuity improvement and detailed retinal healing patterns as their main outcomes. The total follow-up period spans three months, during which safety and healing progress are closely monitored.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with idiopathic full-thickness macular hole
  • Macular hole with horizontal diameter of 400 micrometers or larger
Not Eligible

You will not qualify if you...

  • Media opacity preventing adequate OCT/OCTA imaging
  • Presence of other retinal vascular diseases such as retinal vascular occlusion
  • Intraoperative complications
  • Signal noise ratio of OCTA less than 6/10
  • Poor eye fixation during imaging procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo surgical repair of the macular hole using either Tenon capsule graft or ILM flap techniques under topical anesthesia. Surgery includes vitrectomy and use of SF6 gas tamponade.

1 visit (in-person)

Post-operative Follow-up

Duration - 3 months

Participants are followed after surgery with full ophthalmic examinations and imaging assessments including OCT and OCTA to evaluate anatomical closure and macular perfusion.

2 visits (1 day and 3 months post-surgery, in-person)

Trial Site Locations

Total: 1 location

1

Ain Shams University

Cairo, Abbassia, Egypt

Actively Recruiting

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Research Team

K

Khaled Nehad Elsherief

M

Mohammad Ahmed Rashad

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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