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

NCT07760259 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-12

No results posted yet for this study

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.

Conditions

  • Macular Holes
  • Macular Hole Surgery

Interventions

PROCEDURE

Autologous Tenon's Capsule Autograft

Participants undergo standard 23-gauge pars plana vitrectomy for large or recurrent full-thickness macular holes. An autologous Tenon's capsule graft is harvested from the superior bulbar conjunctiva, trimmed to the appropriate size, and implanted into the macular hole under perfluorocarbon liquid. The procedure is completed with 5000-centistoke silicone oil tamponade. Patients are instructed to maintain face-down positioning for 5 to 7 days after surgery and are followed for 6 months to evaluate anatomical closure, visual outcomes, graft integration, and postoperative complications.

Sponsors & Collaborators

  • Benha University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-05
Primary Completion
2026-04-03
Completion
2026-05-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07760259 on ClinicalTrials.gov