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Macular HolesFTMH-10NCT07606404

Full-Thickness Macular Hole Surgery: A Comparison of Ten Techniques

A study testing Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery, Autologous Platelet-Rich Plasma (PRP) and Human Amniotic Membrane (hAM) Graft in people with Macular Holes, run by Kazakh Eye Research Institute at 1 site in Kazakhstan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Macular Holes
What is being tested?
Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery, Autologous Platelet-Rich Plasma (PRP) and Human Amniotic Membrane (hAM) Graft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteKazakhstan
Study dates
25 May 2026to 27 May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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.
  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • Advanced age-related macular degeneration (AMD) with foveal atrophy.
  • Prior Interventions:
  • Any prior pars plana vitrectomy in the study eye.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sanzhar Sambet, MD contact

+77758719834

sanzhrs@gmail.com

Kairat Ruslanuly, MD contact

+77019008387

ruslanuly.kairat@gmail.com

Kazakhstan1 site, 1 recruiting
  • Kazakh Eye Research Institute

    Almaty, Almaty, 050042

    Sanzhar Sambet, MD, +77758719834, sanzhrs@gmail.com

    Recruiting

Other trials in Kazakhstan

About this study

Official title: 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.

Read the 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.

Conditions
Macular Holes
Being tested
Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery, Autologous Platelet-Rich Plasma (PRP), Human Amniotic Membrane (hAM) Graft
Keywords
Full-Thickness Macular Hole, Pars Plana Vitrectomy, Internal Limiting Membrane Peeling, Inverted ILM Flap, ILM Flap, Optical Coherence Tomography, Macular Hole Closure, Best-Corrected Visual Acuity, Platelet-Rich Plasma, Amniotic Membrane Graft, Macular Hydrodissection, Surgical Technique
Medical subject headings
Retinal Perforations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pars Plana Vitrectomy (PPV)-Based Macular Hole SurgeryProcedure or 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.

  • Autologous Platelet-Rich Plasma (PRP)Biological

    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) GraftOther

    Human amniotic membrane (hAM) graft placed intraoperatively for macular hole repair, according to the study protocol.

Study groups in NCT07606404
Study groupRoleWhat they receive
PPV + PVD Induction Without ILM Peel/FlapActive comparatorPars plana vitrectomy (PPV) with induction of posterior vitreous detachment (PVD) performed without internal limiting membrane (ILM) peeling and without an ILM flap.
Receives: Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery
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).
Receives: Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery
PPV + 360° Inverted ILM FlapActive 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.
Receives: Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery
PPV + Superior Hinged ILM FlapActive 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.
Receives: Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery
PPV + Temporal Hinged ILM FlapActive 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.
Receives: Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery
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.
Receives: Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery
PPV + ILM removal + inverted flap + PRPActive 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.
Receives: Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery; Biological: Autologous Platelet-Rich Plasma (PRP)
PPV + ILM removal + PRPActive 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.
Receives: Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery; Biological: Autologous Platelet-Rich Plasma (PRP)
PPV + ILM Peeling + Human Amniotic Membrane (hAM) GraftActive 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.
Receives: Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery; Other: Human Amniotic Membrane (hAM) Graft
PPV + Macular Edge HydrodissectionActive 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.
Receives: Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Macular Hole Closure at 7 days

    Proportion of participants with OCT-confirmed anatomical macular hole closure.

    Measured: 7 day

  2. Macular Hole Closure at 1month

    Proportion of participants with OCT-confirmed anatomical macular hole closure.

    Measured: 1 month

  3. Macular Hole Closure at 1 Year

    Proportion of participants with OCT-confirmed anatomical macular hole closure.

    Measured: 1 year

Secondary outcomes (3)
  1. BCVA at Day 7

    Best-corrected visual acuity (BCVA) measured at Day 7 after surgery and recorded in logMAR units.

    Measured: 7 days

  2. BCVA at 1 Month

    Best-corrected visual acuity (BCVA) measured at 1 month after surgery and recorded in logMAR units.

    Measured: 1 month

  3. BCVA at 1 Year

    Best-corrected visual acuity (BCVA) measured at 1 year after surgery and recorded in logMAR units.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2026
  2. Study start25 May 2026
  3. Primary completion27 May 2027 (estimated)
  4. Study completion27 May 2028 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Parallel-group randomized trial comparing ten PPV-based surgical techniques for full-thickness macular hole repair, with stratified randomization by macular hole size into five predefined MLD strata.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07606404
Sponsor's protocol ID
IRB-538-2026
Acronym
FTMH-10
Status last verified
May 2026
First submitted
15 May 2026
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This study does not plan to share individual participant data (IPD) publicly. De-identified aggregated results may be shared in publications and presentations.

Questions about this trial

What is this clinical trial studying?

A study testing Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery, Autologous Platelet-Rich Plasma (PRP) and Human Amniotic Membrane (hAM) Graft in people with Macular Holes, run by Kazakh Eye Research Institute at 1 site in Kazakhstan.

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 14 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: looking for participants now, as of the sponsor's last update on 2 Jun 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 Kazakhstan. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sanzhar Sambet, MD (+77758719834, sanzhrs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Macular Hole Closure at 7 days (time frame: 7 day). The study lists 3 primary outcomes in all. 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 2 Jun 2026.

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