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Full-Thickness Macular Hole Surgery: A Comparison of Ten Techniques (FTMH-10)

29 mai 2026 mis à jour par: Kairat Ruslanuly, Kazakh Eye Research Institute

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

120

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Sanzhar Sambet, MD
  • Numéro de téléphone: +77758719834
  • E-mail: sanzhrs@gmail.com

Lieux d'étude

  • Kazakhstan
    • Almaty
      • Almaty, Almaty, Kazakhstan, 050042
        • Recrutement
        • Kazakh Eye Research Institute
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Procédure: 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.
Comparateur actif: 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).
Procédure: 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.
Comparateur actif: 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.
Procédure: 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.
Comparateur actif: 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.
Procédure: 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.
Comparateur actif: 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.
Procédure: 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.
Comparateur actif: 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.
Procédure: 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.
Comparateur actif: 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.
Procédure: 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.
Biologique: 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.
Comparateur actif: 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.
Procédure: 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.
Biologique: 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.
Comparateur actif: 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.
Procédure: 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.
Autre: Human Amniotic Membrane (hAM) Graft
Human amniotic membrane (hAM) graft placed intraoperatively for macular hole repair, according to the study protocol.
Comparateur actif: 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.
Procédure: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Macular Hole Closure at 7 days
Délai: 7 day
Proportion of participants with OCT-confirmed anatomical macular hole closure.
7 day
Macular Hole Closure at 1month
Délai: 1 month
Proportion of participants with OCT-confirmed anatomical macular hole closure.
1 month
Macular Hole Closure at 1 Year
Délai: 1 year
Proportion of participants with OCT-confirmed anatomical macular hole closure.
1 year

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
BCVA at Day 7
Délai: 7 days
Best-corrected visual acuity (BCVA) measured at Day 7 after surgery and recorded in logMAR units.
7 days
BCVA at 1 Month
Délai: 1 month
Best-corrected visual acuity (BCVA) measured at 1 month after surgery and recorded in logMAR units.
1 month
BCVA at 1 Year
Délai: 1 year
Best-corrected visual acuity (BCVA) measured at 1 year after surgery and recorded in logMAR units.
1 year

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Kazakh Eye Research Institute

Les enquêteurs

  • Chercheur principal: Sanzhar Sambet Sambet, MD, Kazakh Eye Research Institute

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

25 mai 2026

Achèvement primaire (Estimé)

27 mai 2027

Achèvement de l'étude (Estimé)

27 mai 2028

Dates d'inscription aux études

Première soumission

15 mai 2026

Première soumission répondant aux critères de contrôle qualité

19 mai 2026

Première publication (Réel)

26 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IRB-538-2026

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

This study does not plan to share individual participant data (IPD) publicly. De-identified aggregated results may be shared in publications and presentations.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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