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NCT Number: NCT07318961

Autologous Tenon's Capsule Graft for Refractory Macular Holes

This prospective interventional study evaluates the anatomical and functional outcomes of autologous Tenon's capsule grafting in patients with refractory full-thickness macular holes. Eligible patients include those with chronic large macular holes (>400 µm) or persistent holes following prior pars plana vitrectomy with internal limiting membrane peeling and gas tamponade. Anatomical closure will be assessed using spectral-domain optical coherence tomography, and functional outcomes will be evaluated by best-corrected visual acuity over a 3-month follow-up period.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University

Banhā, Benha, 13111, Egypt

Location status: Recruiting

Location contact

Mohamed Ismael Ramadan, assistant lecturer

CONTACT

[email protected]

00201090506166

About this study

Refractory full-thickness macular holes represent a significant surgical challenge, with reduced closure rates following conventional techniques, particularly in large or chronic defects. Autologous tissue grafting has emerged as an alternative strategy to provide a biological scaffold for retinal tissue bridging and gliosis. Tenon's capsule is a readily accessible autologous fibrovascular tissue that can be harvested intraoperatively with minimal morbidity.

This prospective single-arm clinical study aims to assess the anatomical closure rate and visual outcomes following autologous Tenon's capsule graft placement in refractory macular holes. All patients will undergo standard pars plana vitrectomy, placement of a trimmed Tenon's graft into the macular hole, and silicone oil tamponade. Outcomes will be evaluated using standardized visual acuity testing and spectral-domain OCT imaging at predefined postoperative intervals.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Refractory full-thickness macular hole defined as:
  • Chronic macular hole >400 µm, or
  • Persistent macular hole following prior vitrectomy with ILM peeling and gas tamponade
  • Clear ocular media and adequate fixation for OCT imaging
  • Ability to provide informed consent

Exclusion criteria

  • Active ocular infection or inflammation
  • Advanced glaucoma or optic neuropathy
  • History of intraocular tumors
  • Severe proliferative vitreoretinopathy
  • Significant systemic diseases likely to affect visual recovery

Treatment and study plan

Autologous Tenon's Capsule Graft Placement

Procedure

Participants will undergo 23-gauge pars plana vitrectomy. Autologous Tenon's capsule tissue will be harvested through conjunctival peritomy, trimmed appropriately, and placed into the macular hole using intraocular forceps. Perfluorocarbon liquid may be used for graft stabilization, followed by silicone oil tamponade. Silicone oil removal is planned after 8-12 weeks.

Primary outcomes

  1. Macular hole anatomical closure

    Time frame: 3 months postoperatively

    Complete closure of the macular hole as confirmed by spectral-domain OCT

Secondary outcomes

  1. Change in Best-Corrected Visual Acuity (logMAR)

    Time frame: Baseline (preoperative), 1 month postoperatively, and 3 months postoperatively

    Change in best-corrected visual acuity (BCVA), measured in logMAR units, comparing postoperative values with baseline (preoperative) BCVA to assess functional visual improvement following autologous Tenon's capsule graft surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Ehab Mohamed Elsayed Saad Saad, lecturer

CONTACT

[email protected]

00201008418667

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Visual and Anatomical Outcomes of Autologous Tenon's Capsule Graft for Refractory Macular Holes

Acronym: ATCG-RMH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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