Full-Thickness Macular Hole Surgery: A Comparison of Ten Techniques
FTMH-10
Vitreoretinal Surgery for Full-Thickness Macular Hole: A Comparative Study of Ten Techniques
1 other identifier
interventional
120
1 country
1
Brief Summary
This study compares ten modern vitreoretinal surgical techniques for full-thickness macular hole repair. Participants will be randomly assigned to one of the surgical approaches during pars plana vitrectomy, using stratified randomization based on macular hole size to ensure balanced groups. The main goal is to determine which technique provides the highest anatomical closure rate on optical coherence tomography (OCT) and the best visual outcomes. Follow-up visits are scheduled at Day 7, Month 1, and Year 1 after surgery to assess OCT findings, visual acuity, safety outcomes, and the need for reoperation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2026
CompletedStudy Start
First participant enrolled
May 25, 2026
CompletedFirst Posted
Study publicly available on registry
May 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 27, 2028
June 2, 2026
May 1, 2026
1 year
May 15, 2026
May 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Macular Hole Closure at 7 days
Proportion of participants with OCT-confirmed anatomical macular hole closure.
7 day
Macular Hole Closure at 1month
Proportion of participants with OCT-confirmed anatomical macular hole closure.
1 month
Macular Hole Closure at 1 Year
Proportion of participants with OCT-confirmed anatomical macular hole closure.
1 year
Secondary Outcomes (3)
BCVA at Day 7
7 days
BCVA at 1 Month
1 month
BCVA at 1 Year
1 year
Study Arms (10)
PPV + PVD Induction Without ILM Peel/Flap
ACTIVE COMPARATORPars plana vitrectomy (PPV) with induction of posterior vitreous detachment (PVD) performed without internal limiting membrane (ILM) peeling and without an ILM flap.
PPV + ERM peel + circular ILM peel (classic)
ACTIVE COMPARATORPars plana vitrectomy (PPV) with epiretinal membrane (ERM) peeling (if present) followed by standard circular internal limiting membrane (ILM) peeling around the fovea (classic technique).
PPV + 360° Inverted ILM Flap
ACTIVE COMPARATORPars plana vitrectomy (PPV) with creation of a circumferential (360°) internal limiting membrane (ILM) flap that is inverted to cover the macular hole, according to the study protocol.
PPV + Superior Hinged ILM Flap
ACTIVE COMPARATORPars plana vitrectomy (PPV) with creation of a superior hinged internal limiting membrane (ILM) flap left attached at the superior edge and inverted to cover the macular hole, according to the study protocol.
PPV + Temporal Hinged ILM Flap
ACTIVE COMPARATORPars plana vitrectomy (PPV) with creation of a temporal hinged internal limiting membrane (ILM) flap, left attached at the temporal edge, and inverted to cover the macular hole, according to the study protocol.
PPV + Multiflap ILM Flap (Cabbage Leaf/Star)
ACTIVE COMPARATORPars plana vitrectomy (PPV) with creation of multiple small internal limiting membrane (ILM) flaps (multiflap "cabbage leaf/star" technique) positioned to cover the macular hole, according to the study protocol.
PPV + ILM removal + inverted flap + PRP
ACTIVE COMPARATORPars plana vitrectomy (PPV) with internal limiting membrane (ILM) removal and an inverted ILM flap technique. Autologous platelet-rich plasma (PRP) is applied to the macular hole area as an adjunct, according to the study protocol.
PPV + ILM removal + PRP
ACTIVE COMPARATORPars plana vitrectomy (PPV) with standard internal limiting membrane (ILM) peeling (no ILM flap technique). Autologous platelet-rich plasma (PRP) is applied to the macular hole area as an adjunct, according to the study protocol.
PPV + ILM Peeling + Human Amniotic Membrane (hAM) Graft
ACTIVE COMPARATORPars plana vitrectomy (PPV) with standard internal limiting membrane (ILM) peeling followed by placement of a human amniotic membrane (hAM) graft for full-thickness macular hole repair, according to the study protocol.
PPV + Macular Edge Hydrodissection
ACTIVE COMPARATORPars plana vitrectomy (PPV) with controlled hydrodissection (hydromobilization) of the macular hole edges using balanced salt solution to gently separate and mobilize the retinal margins before macular hole closure, according to the study protocol.
Interventions
Pars plana vitrectomy (PPV) for full-thickness macular hole repair performed according to the randomized assigned technique (e.g., ERM peel, ILM peeling, ILM flap configurations, or macular edge hydrodissection), as specified in the protocol.
Autologous platelet-rich plasma (PRP) applied intraoperatively to the macular hole area as an adjunct to surgery, according to the study protocol.
Human amniotic membrane (hAM) graft placed intraoperatively for macular hole repair, according to the study protocol.
Eligibility Criteria
You may qualify if:
- Adults aged ≥18 years.
- Full-thickness macular hole (FTMH) eligible for pars plana vitrectomy (PPV).
- Symptom duration ≤12 months.
- Clear ocular media sufficient for high-quality OCT imaging.
- No prior pars plana vitrectomy in the study eye.
- No severe foveal atrophy on OCT.
- Able and willing to comply with postoperative positioning and follow-up visits.
- Written informed consent provided.
You may not qualify if:
- A. Etiology-Related / Secondary Macular Holes:
- Traumatic macular hole.
- High myopia with posterior staphyloma (axial length \>28 mm and/or spherical equivalent ≤-8.0 D).
- Diabetic tractional retinal detachment (TRD) or significant tractional maculopathy.
- Retinal vascular occlusion-related macular hole.
- Uveitis-related macular hole.
- Advanced age-related macular degeneration (AMD) with foveal atrophy.
- B. Prior Interventions:
- Any prior pars plana vitrectomy in the study eye.
- C. Ocular Conditions That May Affect Outcomes or Safety:
- Active or recent ocular infection or inflammation (e.g., uveitis, endophthalmitis, keratitis).
- Uncontrolled glaucoma (intraocular pressure \>28 mmHg despite treatment).
- Media opacity precluding adequate OCT (e.g., dense cataract or corneal opacity).
- Geographic atrophy involving the fovea.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kazakh Eye Research Institute
Almaty, Almaty, 050042, Kazakhstan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sanzhar Sambet Sambet, MD
Kazakh Eye Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Scientific Researcher
Study Record Dates
First Submitted
May 15, 2026
First Posted
May 26, 2026
Study Start
May 25, 2026
Primary Completion (Estimated)
May 27, 2027
Study Completion (Estimated)
May 27, 2028
Last Updated
June 2, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
This study does not plan to share individual participant data (IPD) publicly. De-identified aggregated results may be shared in publications and presentations.