Macular Holes, Macular Hole Surgery
Conditions
Keywords
Large macular hole, Autologous Tenon's capsule graft, Vitrectomy, Chronic macular hole
Brief 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. 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.
Interventions
PROCEDUREAutologous Tenon's Capsule Autograft
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.
Sponsors
Benha University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Macular Hole Closure Rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best-Corrected Visual Acuity (BCVA) | 1 month, 3 months, and 6 months after surgery | Change in best-corrected visual acuity measured in logarithm of the minimum angle of resolution (logMAR) from baseline to postoperative follow-up visits. |
Countries
Egypt
Outcome results
None listed