Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with idiopathic full-thickness macular hole
- Macular hole with horizontal diameter of 400 micrometers or larger
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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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