Autologous Tenon's Capsule Graft for Refractory Macular Holes

ConditionMacular Hole Surgery

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorBenha University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

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

Disqualifiers

Active ocular infection or inflammation

Advanced glaucoma or optic neuropathy

History of intraocular tumors

Severe proliferative vitreoretinopathy

Trial design

Design model

Single group

Treatments tested in this trial

Autologous Tenon's Capsule Graft Placement
Procedure/Surgery
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.

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Autologous Tenon's Capsule GraftOther 1 intervention

Trial outcomes

Primary outcomes

Macular hole anatomical closure

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

Time frame

3 months postoperatively

Secondary outcomes

Change in Best-Corrected Visual Acuity (logMAR)

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.

Time frame

Baseline (preoperative), 1 month postoperatively, and 3 months postoperatively

Sponsors and contacts

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Benha University

Lead sponsor

Source ClinicalTrials.gov

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