Comparing microvascular changes after macular hole repair with and without ILM flap
Macular Micro Vascular Changes Following Macular Hole Repair : Optical Coherence Tomography Angiography Study
This study is testing if using a special flap during surgery for macular holes helps improve vision and blood flow in the eye compared to surgery without the flap.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Fayoum University Academic / other |
| Locations | 1 site (Giza) |
| Trial ID | NCT06233500 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the microvascular and structural changes in the macula following the surgical repair of idiopathic full thickness macular holes. Participants will undergo pars plana vitrectomy and be divided into two groups: one receiving an internal limiting membrane (ILM) flap and the other not. The study will utilize optical coherence tomography angiography (OCTA) to assess changes pre- and post-operatively, focusing on visual recovery and the prognostic value of microvascular status. A total of 28 eyes will be included in the study, with data collected on demographics, medical history, and clinical examinations.
Who should consider this trial
Good fit: Ideal candidates are individuals with idiopathic full thickness macular holes without retinal detachment.
Not a fit: Patients with previous eye surgeries, high myopia, or other retinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and visual recovery for patients with macular holes.
How similar studies have performed: Other studies have shown promising results with similar surgical approaches, but this specific comparison of ILM flap techniques is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Idiopathic full thickness Macular hole without retinal detachment Exclusion Criteria: * Previous pars plana vitrectomy * High myopia with axial length ≥ 26 mm. * Uncertain symptom duration or ≥ 6 month . * History of same eye trauma * Poor image quality. * Patients with diabetic retinopathy or other retinal diseases, e.g. ischemic, inflammatory. * Any patient with significant cataract which needs combined phaco-vitrectomy.
Where this trial is running
Giza
- research institute of ophthalmology, Egypt — Giza, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed Husssein
- Email: mhmm1004@hotmail.com
- Phone: +201015479856
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.