Autologous Tenon's Capsule Graft for Refractory Macular Holes (ATCG-RMH)
Visual and Anatomical Outcomes of Autologous Tenon's Capsule Graft for Refractory Macular Holes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ehab Mohamed Elsayed Saad Saad, lecturer
- Phone Number: 00201008418667
- Email: ehab.saad@fmed.bu.edu.eg
Study Locations
-
-
Benha
-
Banhā, Benha, Egypt, 13111
- Recruiting
- Benha University
-
Contact:
- Mohamed Ismael Ramadan, assistant lecturer
- Phone Number: 00201090506166
- Email: ehab.saad@fmed.bu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Autologous Tenon's Capsule Graft
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Macular hole anatomical closure
Time Frame: 3 months postoperatively
|
Complete closure of the macular hole as confirmed by spectral-domain OCT
|
3 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (preoperative), 1 month postoperatively, and 3 months postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Macular hole rapair
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.