Macular HolesATCG-MHNCT07760259
Autologous Tenon's Capsule Autograft for Large and Recurrent Full-Thickness Macular Holes
A study testing Autologous Tenon's Capsule Autograft in people with Macular Holes and Macular Hole Surgery, run by Benha University at 1 site in Egypt.
Trial summary
This prospective interventional clinical trial aims to evaluate the anatomical and functional outcomes of autologous Tenon's capsule autograft in the surgical management of large and recurrent full-thickness macular holes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Holes, Macular Hole Surgery
- What is being tested?
- Autologous Tenon's Capsule Autograft
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jul 2025to 15 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults aged 18 years or older.
- Large full-thickness macular hole (minimum diameter >400 µm on optical coherence tomography).
- Chronic macular hole (duration >6 months).
- Recurrent or persistent full-thickness macular hole following previous vitrectomy with or without internal limiting membrane peeling.
- High-myopic full-thickness macular hole (axial length >26 mm) without active foveoschisis or retinal detachment.
- No active ocular infection or uncontrolled intraocular inflammation.
- Able and willing to comply with postoperative face-down positioning and scheduled follow-up visits.
- Provided written informed consent.
Who cannot join
- Macular hole associated with rhegmatogenous, tractional, exudative, or combined retinal detachment.
- Significant ocular comorbidities that could affect visual outcomes (e.g., advanced glaucoma, proliferative diabetic retinopathy, or severe uveitis).
- Active intraocular infection or inflammation.
- Extensive macular atrophy or scarring (e.g., end-stage myopic degeneration).
- Unhealthy Tenon's capsule or severe conjunctival scarring preventing adequate graft harvest.
- Systemic conditions that preclude vitreoretinal surgery or impair wound healing, including uncontrolled diabetes mellitus or bleeding disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Autologous Tenon's Capsule Autograft for Large and Recurrent Full-Thickness Macular Holes: A Prospective Interventional Clinical Trial
This prospective interventional clinical trial aims to evaluate the anatomical and functional outcomes of autologous Tenon's capsule autograft in the surgical management of large and recurrent full-thickness macular holes. Patients with large (>400 µm), chronic, recurrent, or highly myopic macular holes will undergo 23-gauge pars plana vitrectomy with placement of an autologous Tenon's capsule graft into the macular hole followed by silicone oil tamponade. The primary outcome is anatomical macular hole closure confirmed by spectral-domain optical coherence tomography (SD-OCT). Secondary outcomes include best-corrected visual acuity, graft integration, and postoperative complications during a 6-month follow-up period.
Read the detailed description
Large, chronic, and recurrent full-thickness macular holes remain challenging to treat despite advances in vitreoretinal surgery. Although pars plana vitrectomy with internal limiting membrane peeling achieves high closure rates in primary macular holes, anatomical success is reduced in very large or recurrent cases. Alternative surgical techniques, including inverted internal limiting membrane flaps, autologous retinal transplantation, and human amniotic membrane grafts, have demonstrated promising results but may be technically demanding or have limited availability. Autologous Tenon's capsule is an easily accessible, biocompatible tissue that may provide an effective scaffold for macular hole closure while avoiding the disadvantages associated with other grafting techniques.
This is a prospective, single-center interventional clinical trial conducted at the Department of Ophthalmology, Zagazig University Hospitals. Fifty eligible adult patients with large (>400 µm), chronic, recurrent, or high-myopic full-thickness macular holes will be enrolled. All participants will undergo standard 23-gauge pars plana vitrectomy. Residual internal limiting membrane will be re-peeled when present, followed by harvesting an autologous Tenon's capsule graft from the superior bulbar conjunctiva. The graft will be trimmed, inserted into the macular hole under perfluorocarbon liquid, and stabilized with 5000-centistoke silicone oil tamponade. Patients will maintain a face-down position for 5 to 7 days after surgery.
Participants will be examined on postoperative day 1, at week 1, and at months 1, 3, and 6. Anatomical closure of the macular hole will be assessed using spectral-domain optical coherence tomography, while functional outcomes will be evaluated by best-corrected visual acuity. Additional assessments include graft position and integration on OCT, intraocular pressure, and the occurrence of postoperative complications such as graft displacement, retinal detachment, or endophthalmitis. The primary outcome is macular hole closure at 3 months, and secondary outcomes include best-corrected visual acuity at 1, 3, and 6 months, graft integration, and postoperative complications.
- Conditions
- Macular Holes, Macular Hole Surgery
- Being tested
- Autologous Tenon's Capsule Autograft
- Keywords
- Large macular hole, Autologous Tenon's capsule graft, Vitrectomy, Chronic 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 AutograftProcedure or surgery
Participants undergo standard 23-gauge pars plana vitrectomy for large or recurrent full-thickness macular holes. An autologous Tenon's capsule graft is harvested from the superior bulbar conjunctiva, trimmed to the appropriate size, and implanted into the macular hole under perfluorocarbon liquid. The procedure is completed with 5000-centistoke silicone oil tamponade. Patients are instructed to maintain face-down positioning for 5 to 7 days after surgery and are followed for 6 months to evaluate anatomical closure, visual outcomes, graft integration, and postoperative complications.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Tenon's Capsule Autograft | Experimental | Participants with large, chronic, recurrent, or high-myopic full-thickness macular holes will undergo 23-gauge pars plana vitrectomy with harvesting and implantation of an autologous Tenon's capsule graft into the macular hole under perfluorocarbon liquid, followed by 5000-centistoke silicone oil tamponade. Participants will be followed for 6 months to assess anatomical closure, visual outcomes, graft integration, and postoperative complications. Receives: Procedure: Autologous Tenon's Capsule Autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular Hole Closure Rate
Anatomical closure of the full-thickness macular hole confirmed by spectral-domain optical coherence tomography (SD-OCT). Successful closure is defined as complete approximation of the neurosensory retina over the fovea without a persistent full-thickness defect.
Measured: 3 months after surgery
Secondary outcomes (1)
Best-Corrected Visual Acuity (BCVA)
Change in best-corrected visual acuity measured in logarithm of the minimum angle of resolution (logMAR) from baseline to postoperative follow-up visits.
Measured: 1 month, 3 months, and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start5 Jul 2025
- Primary completion3 Apr 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HolesStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Model description
- All enrolled participants will undergo 23-gauge pars plana vitrectomy with placement of an autologous Tenon's capsule autograft for the treatment of large or recurrent full-thickness macular holes followed by silicone oil tamponade. Participants will be followed for 6 months to evaluate anatomical and functional outcomes.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
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
- NCT07760259
- Sponsor's protocol ID
- ZU-OPH-ATCG-MH-2025
- Acronym
- ATCG-MH
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Autologous Tenon's Capsule Autograft for Large and Recurrent Full-Thickness Macular Holes: A Prospective Interventional Clinical Trial
- ClinicalTrials.gov ID
- NCT07760259
- Acronym / sponsor ID
- ATCG-MH / ZU-OPH-ATCG-MH-2025
- Conditions
- Macular Holes, Macular Hole Surgery
- Keywords
- Large macular hole, Autologous Tenon's capsule graft, Vitrectomy, Chronic macular hole
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 5 Jul 2025 (actual)
- Primary completion
- 3 Apr 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective interventional clinical trial aims to evaluate the anatomical and functional outcomes of autologous Tenon's capsule autograft in the surgical management of large and recurrent full-thickness macular holes. Patients with large (>400 µm), chronic, recurrent, or highly myopic macular holes will undergo 23-gauge pars plana vitrectomy with placement of an autologous Tenon's capsule graft into the macular hole followed by silicone oil tamponade. The primary outcome is anatomical macular hole closure confirmed by spectral-domain optical coherence tomography (SD-OCT). Secondary outcomes include best-corrected visual acuity, graft integration, and postoperative complications during a 6-month follow-up period.
Detailed description
Large, chronic, and recurrent full-thickness macular holes remain challenging to treat despite advances in vitreoretinal surgery. Although pars plana vitrectomy with internal limiting membrane peeling achieves high closure rates in primary macular holes, anatomical success is reduced in very large or recurrent cases. Alternative surgical techniques, including inverted internal limiting membrane flaps, autologous retinal transplantation, and human amniotic membrane grafts, have demonstrated promising results but may be technically demanding or have limited availability. Autologous Tenon's capsule is an easily accessible, biocompatible tissue that may provide an effective scaffold for macular hole closure while avoiding the disadvantages associated with other grafting techniques.
This is a prospective, single-center interventional clinical trial conducted at the Department of Ophthalmology, Zagazig University Hospitals. Fifty eligible adult patients with large (>400 µm), chronic, recurrent, or high-myopic full-thickness macular holes will be enrolled. All participants will undergo standard 23-gauge pars plana vitrectomy. Residual internal limiting membrane will be re-peeled when present, followed by harvesting an autologous Tenon's capsule graft from the superior bulbar conjunctiva. The graft will be trimmed, inserted into the macular hole under perfluorocarbon liquid, and stabilized with 5000-centistoke silicone oil tamponade. Patients will maintain a face-down position for 5 to 7 days after surgery.
Participants will be examined on postoperative day 1, at week 1, and at months 1, 3, and 6. Anatomical closure of the macular hole will be assessed using spectral-domain optical coherence tomography, while functional outcomes will be evaluated by best-corrected visual acuity. Additional assessments include graft position and integration on OCT, intraocular pressure, and the occurrence of postoperative complications such as graft displacement, retinal detachment, or endophthalmitis. The primary outcome is macular hole closure at 3 months, and secondary outcomes include best-corrected visual acuity at 1, 3, and 6 months, graft integration, and postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will undergo 23-gauge pars plana vitrectomy with placement of an autologous Tenon's capsule autograft for the treatment of large or recurrent full-thickness macular holes followed by silicone oil tamponade. Participants will be followed for 6 months to evaluate anatomical and functional outcomes.
| Arm | Type | Receives |
|---|---|---|
| Autologous Tenon's Capsule Autograft | Experimental | Procedure: Autologous Tenon's Capsule AutograftParticipants with large, chronic, recurrent, or high-myopic full-thickness macular holes will undergo 23-gauge pars plana vitrectomy with harvesting and implantation of an autologous Tenon's capsule graft into the macular hole under perfluorocarbon liquid, followed by 5000-centistoke silicone oil tamponade. Participants will be followed for 6 months to assess anatomical closure, visual outcomes, graft integration, and postoperative complications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 years or older.
- Large full-thickness macular hole (minimum diameter >400 µm on optical coherence tomography).
- Chronic macular hole (duration >6 months).
- Recurrent or persistent full-thickness macular hole following previous vitrectomy with or without internal limiting membrane peeling.
- High-myopic full-thickness macular hole (axial length >26 mm) without active foveoschisis or retinal detachment.
Key exclusion criteria (6 listed)
- Macular hole associated with rhegmatogenous, tractional, exudative, or combined retinal detachment.
- Significant ocular comorbidities that could affect visual outcomes (e.g., advanced glaucoma, proliferative diabetic retinopathy, or severe uveitis).
- Active intraocular infection or inflammation.
- Extensive macular atrophy or scarring (e.g., end-stage myopic degeneration).
- Unhealthy Tenon's capsule or severe conjunctival scarring preventing adequate graft harvest.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Tenon's Capsule AutograftParticipants undergo standard 23-gauge pars plana vitrectomy for large or recurrent full-thickness macular holes. An autologous Tenon's capsule graft is harvested from the superior bulbar conjunctiva, trimmed to the appropriate size, and implanted into the macular hole under perfluorocarbon liquid. The procedure is completed with 5000-centistoke silicone oil tamponade. Patients are instructed to maintain face-down positioning for 5 to 7 days after surgery and are followed for 6 months to evaluate anatomical closure, visual outcomes, graft integration, and postoperative complications. | Procedure or surgery | Autologous Tenon's Capsule Autograft |
Primary outcome
Macular Hole Closure Rate
Time frame: 3 months after surgery
Anatomical closure of the full-thickness macular hole confirmed by spectral-domain optical coherence tomography (SD-OCT). Successful closure is defined as complete approximation of the neurosensory retina over the fovea without a persistent full-thickness defect.
1 secondary outcome
Best-Corrected Visual Acuity (BCVA)
Time frame: 1 month, 3 months, and 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Tenon's Capsule Autograft in people with Macular Holes and Macular Hole Surgery, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular Hole Closure Rate (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.