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Completed NCT07760259

Autologous Tenon's Capsule Autograft for Large and Recurrent Full-Thickness Macular Holes

Conditions: Macular Holes, Macular Hole Surgery

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Benha University

Location: Benha University Banhā Benha

Summary

This prospective interventional clinical trial aims to evaluate the anatomical and functional outcomes of autologous Tenon's capsule autograft in the surgical management of large and recurrent full-thickness macular holes. Patients with large (\>400 µm), chronic, recurrent, or highly myopic macular holes will undergo 23-gauge pars plana vitrectomy with placement of an autologous Tenon's capsule graft into the macular hole followed by silicone oil tamponade. The primary outcome is anatomical macular hole closure confirmed by spectral-domain optical coherence tomography (SD-OCT). Secondary outcomes include best-corrected visual acuity, graft integration, and postoperative complications during a 6-month follow-up period.

Eligibility Criteria

Inclusion Criteria: * Adults aged 18 years or older. * Large full-thickness macular hole (minimum diameter \>400 µm on optical coherence tomography). * Chronic macular hole (duration \>6 months). * Recurrent or persistent full-thickness macular hole following previous vitrectomy with or without internal limiting membrane peeling. * High-myopic full-thickness macular hole (axial length \>26 mm) without active foveoschisis or retinal detachment. * No active ocular infection or uncontrolled intraocular inflammation. * Able and willing to comply with postoperative face-down positioning and scheduled follow-up visits. * Provided written informed consent. Exclusion Criteria: * Macular hole associated with rhegmatogenous, tractional, exudative, or combined retinal detachment. * Significant ocular comorbidities that could affect visual outcomes (e.g., advanced glaucoma, proliferative diabetic retinopathy, or severe uveitis). * Active intraocular infection or inflammation. * Extensive macular atrophy or scarring (e.g., end-stage myopic degeneration). * Unhealthy Tenon's capsule or severe conjunctival scarring preventing adequate graft harvest. * Systemic conditions that preclude vitreoretinal surgery or impair wound healing, including uncontrolled diabetes mellitus or bleeding disorders.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07760259). StuddyBuddy aggregates publicly available trial information.