Actively Recruiting
Visual and Anatomical Outcomes of Autologous Tenon's Capsule Graft for Refractory Macular Holes
Led by Benha University · Updated on 2026-01-06
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the anatomical and functional outcomes of using autologous Tenon's capsule grafting in patients with difficult-to-treat full-thickness macular holes. The study focuses on patients with chronic large macular holes larger than 400 micrometers or persistent holes after previous vitrectomy surgery with membrane peeling and gas tamponade. The purpose is to assess how well the macular holes close anatomically and how visual acuity improves over a three-month follow-up period. Participants will receive a surgical procedure involving a 23-gauge pars plana vitrectomy. During surgery, autologous Tenon's capsule tissue will be harvested from the patient's own eye, trimmed, and placed into the macular hole. Perfluorocarbon liquid may be used to help stabilize the graft, and silicone oil will be applied as a tamponade to support healing. Silicone oil removal is planned between 8 to 12 weeks after surgery. Throughout the study, researchers will monitor anatomical closure of the macular hole using spectral-domain optical coherence tomography and measure functional changes by testing best-corrected visual acuity at baseline, one month, and three months after surgery. The study includes evaluations of ocular health, fixation ability, and visual recovery over the three-month follow-up. The total participation duration corresponds to this postoperative monitoring period.
CONDITIONS
Brief Title
Autologous Tenon's Capsule Graft for Refractory Macular Holes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of refractory full-thickness macular hole defined as chronic macular hole larger than 400 micrometers or persistent macular hole after prior vitrectomy with internal limiting membrane peeling and gas tamponade
- Clear ocular media and ability to maintain adequate fixation for OCT imaging
- Ability to provide informed consent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 to 12 weeks
Participants undergo surgery involving pars plana vitrectomy with placement of an autologous Tenon's capsule graft into the macular hole, followed by silicone oil tamponade. Silicone oil removal is planned after 8 to 12 weeks.
1 surgical visit and 1 post-operative visit for silicone oil removal
Duration - Up to 3 months postoperatively
Participants attend follow-up visits to assess anatomical closure and visual acuity outcomes using standardized testing and imaging.
2 visits (1 month and 3 months postoperatively)
Trial Site Locations
Total: 1 location
1
Benha University
Banhā, Benha, Egypt, 13111
Actively Recruiting
Research Team
E
Ehab Mohamed Elsayed Saad Saad, lecturer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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