Health Trials

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

ConditionMacular Holes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKazakh Eye Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery

    Procedure/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/Vaccine

    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

    Other intervention

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

Treatment groups

120 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: PPV + PVD Induction Without ILM Peel/FlapActive comparator 1 intervention
Group B: PPV + ERM peel + circular ILM peel (classic)Active comparator 1 intervention
Group C: PPV + 360° Inverted ILM FlapActive comparator 1 intervention
Group D: PPV + Superior Hinged ILM FlapActive comparator 1 intervention
Group E: PPV + Temporal Hinged ILM FlapActive comparator 1 intervention
Group F: PPV + Multiflap ILM Flap (Cabbage Leaf/Star)Active comparator 1 intervention
Group G: PPV + ILM removal + inverted flap + PRPActive comparator 2 interventions
Group H: PPV + ILM removal + PRPActive comparator 2 interventions
Group I: PPV + ILM Peeling + Human Amniotic Membrane (hAM) GraftActive comparator 2 interventions
Group J: PPV + Macular Edge HydrodissectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Macular Hole Closure at 7 days

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

Time frame
7 day
2

Macular Hole Closure at 1month

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

Time frame
1 month
3

Macular Hole Closure at 1 Year

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

Time frame
1 year

Secondary outcomes

1

BCVA at Day 7

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

Time frame
7 days
2

BCVA at 1 Month

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

Time frame
1 month
3

BCVA at 1 Year

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

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kazakh Eye Research Institute

Lead sponsor

Source ClinicalTrials.gov
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