Macular Hole SurgeryATCG-RMHNCT07318961
Autologous Tenon's Capsule Graft for Refractory Macular Holes
A study testing Autologous Tenon's Capsule Graft Placement in people with Macular Hole Surgery, run by Benha University at 1 site in Egypt.
Trial summary
This prospective interventional study evaluates the anatomical and functional outcomes of autologous Tenon's capsule grafting in patients with refractory full-thickness macular holes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Hole Surgery
- What is being tested?
- Autologous Tenon's Capsule Graft Placement
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Dec 2025to 3 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Benha University
Banhā, Benha, 13111
Mohamed Ismael Ramadan, assistant lecturer, 00201090506166, ehab.saad@fmed.bu.edu.eg
About this study
Official title: Visual and Anatomical Outcomes of 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.
Read the 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.
- Conditions
- Macular Hole Surgery
- Being tested
- Autologous Tenon's Capsule Graft Placement
- Keywords
- Autologous Tenon's Capsule Graft, Macular Hole
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Tenon's Capsule Graft PlacementProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Tenon's Capsule Graft | Other | Procedure Receives: Procedure: Autologous Tenon's Capsule Graft Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular hole anatomical closure
Complete closure of the macular hole as confirmed by spectral-domain OCT
Measured: 3 months postoperatively
Secondary outcomes (1)
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.
Measured: Baseline (preoperative), 1 month postoperatively, and 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start14 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion3 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Hole SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Elsayed Mohamed Saad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318961
- Sponsor's protocol ID
- Macular hole rapair
- Acronym
- ATCG-RMH
- Status last verified
- Sep 2026
- First submitted
- 21 Dec 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No