RecruitingNot ApplicableNCT07633457

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


Sponsor

Ain Shams University

Enrollment

20 participants

Start Date

Nov 9, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Inclusion Criteria2

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

Exclusion Criteria5

  • 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

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Interventions

PROCEDUREvitrectomy 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


Locations(1)

Ain Shams University

Cairo, Abbassia, Egypt

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NCT07633457


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