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

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.

Study Overview

• Status: Recruiting
• Conditions: Macular Holes
• Intervention / Treatment: Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery; Biological: Autologous Platelet-Rich Plasma (PRP); Other: Human Amniotic Membrane (hAM) Graft

Detailed Description

Full-thickness macular hole is a vision-threatening condition that is commonly treated with pars plana vitrectomy (PPV) and internal limiting membrane (ILM) peeling. While standard approaches achieve high closure rates in many cases, outcomes may vary depending on macular hole size and OCT morphology, and advanced surgical strategies (e.g., different ILM flap configurations, adjunctive biologic augmentation, hydrodissection, or grafting techniques) are increasingly used in clinical practice.

This single-center, randomized, parallel-group interventional study will compare ten PPV-based surgical techniques for full-thickness macular hole repair. Eligible participants will include adults with full-thickness macular hole across a broad range of minimum linear diameter (MLD), including MLD <250 µm. After eligibility confirmation and informed consent, participants will be randomized to one of the ten procedure groups. Randomization will be stratified by macular hole size into five predefined MLD strata to ensure balanced distribution of hole sizes across all intervention groups. Postoperative care and follow-up procedures will be standardized across groups according to the study protocol.

Follow-up visits are scheduled at Day 7, Month 1, and Year 1 after surgery and will include clinical examinations and OCT imaging. The primary endpoint is anatomical macular hole closure on OCT at the prespecified primary time point. Secondary endpoints include best-corrected visual acuity (BCVA), OCT-based morphologic recovery parameters, intraoperative and postoperative complication rates, reoperation rates, and adverse event information through Year 1. The study aims to generate evidence to guide selection of surgical technique based on macular hole morphometric and clinical characteristics while maintaining patient safety.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kairat Ruslanuly, MD; Phone Number: +77019008387; Email: ruslanuly.kairat@gmail.com
• Study Contact Backup: Name: Sanzhar Sambet, MD; Phone Number: +77758719834; Email: sanzhrs@gmail.com

Study Locations

• Kazakhstan
  • Almaty
    • Almaty, Almaty, Kazakhstan, 050042
      • Recruiting
      • Kazakh Eye Research Institute
      • Contact: Sanzhar Sambet, MD; Phone Number: +77758719834; Email: sanzhrs@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PPV + PVD Induction Without ILM Peel/Flap; Pars plana vitrectomy (PPV) with induction of posterior vitreous detachment (PVD) performed without internal limiting membrane (ILM) peeling and without an ILM flap.	Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery; 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.
Active Comparator: PPV + ERM peel + circular ILM peel (classic); Pars plana vitrectomy (PPV) with epiretinal membrane (ERM) peeling (if present) followed by standard circular internal limiting membrane (ILM) peeling around the fovea (classic technique).	Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery; 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.
Active Comparator: PPV + 360° Inverted ILM Flap; Pars 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.	Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery; 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.
Active Comparator: PPV + Superior Hinged ILM Flap; Pars 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.	Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery; 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.
Active Comparator: PPV + Temporal Hinged ILM Flap; Pars 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.	Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery; 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.
Active Comparator: PPV + Multiflap ILM Flap (Cabbage Leaf/Star); Pars 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.	Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery; 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.
Active Comparator: PPV + ILM removal + inverted flap + PRP; Pars 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.	Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery; 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.; Biological: Autologous Platelet-Rich Plasma (PRP); Autologous platelet-rich plasma (PRP) applied intraoperatively to the macular hole area as an adjunct to surgery, according to the study protocol.
Active Comparator: PPV + ILM removal + PRP; Pars 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.	Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery; 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.; Biological: Autologous Platelet-Rich Plasma (PRP); Autologous platelet-rich plasma (PRP) applied intraoperatively to the macular hole area as an adjunct to surgery, according to the study protocol.
Active Comparator: PPV + ILM Peeling + Human Amniotic Membrane (hAM) Graft; Pars 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.	Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery; 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.; Other: Human Amniotic Membrane (hAM) Graft; Human amniotic membrane (hAM) graft placed intraoperatively for macular hole repair, according to the study protocol.
Active Comparator: PPV + Macular Edge Hydrodissection; Pars 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.	Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
BCVA at Day 7	Best-corrected visual acuity (BCVA) measured at Day 7 after surgery and recorded in logMAR units.	7 days
BCVA at 1 Month	Best-corrected visual acuity (BCVA) measured at 1 month after surgery and recorded in logMAR units.	1 month
BCVA at 1 Year	Best-corrected visual acuity (BCVA) measured at 1 year after surgery and recorded in logMAR units.	1 year

Collaborators and Investigators

• Sponsor: Kazakh Eye Research Institute
• Investigators: Principal Investigator: Sanzhar Sambet Sambet, MD, Kazakh Eye Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2026
• Primary Completion (Estimated): May 27, 2027
• Study Completion (Estimated): May 27, 2028

Study Registration Dates

• First Submitted: May 15, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Optical Coherence Tomography; Platelet-Rich Plasma; Pars Plana Vitrectomy; Surgical Technique; Full-Thickness Macular Hole; Internal Limiting Membrane Peeling; Inverted ILM Flap; ILM Flap; Macular Hole Closure; Best-Corrected Visual Acuity; Amniotic Membrane Graft; Macular Hydrodissection
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations; Surgical Procedures, Operative; Transplantation; ATF7IP protein, human
• Other Study ID Numbers: IRB-538-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study does not plan to share individual participant data (IPD) publicly. De-identified aggregated results may be shared in publications and presentations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No