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
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Kairat Ruslanuly, MD
- Numer telefonu: +77019008387
- E-mail: ruslanuly.kairat@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Sanzhar Sambet, MD
- Numer telefonu: +77758719834
- E-mail: sanzhrs@gmail.com
Lokalizacje studiów
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Almaty
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Almaty, Almaty, Kazachstan, 050042
- Rekrutacyjny
- Kazakh Eye Research Institute
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Kontakt:
- Sanzhar Sambet, MD
- Numer telefonu: +77758719834
- E-mail: sanzhrs@gmail.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: 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.
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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.
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Aktywny komparator: 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).
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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.
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Aktywny komparator: 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.
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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.
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Aktywny komparator: 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.
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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.
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Aktywny komparator: 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.
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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.
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Aktywny komparator: 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.
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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.
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Aktywny komparator: 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.
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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.
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Aktywny komparator: 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.
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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.
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Aktywny komparator: 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.
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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.
Human amniotic membrane (hAM) graft placed intraoperatively for macular hole repair, according to the study protocol.
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Aktywny komparator: 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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Macular Hole Closure at 7 days
Ramy czasowe: 7 day
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Proportion of participants with OCT-confirmed anatomical macular hole closure.
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7 day
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Macular Hole Closure at 1month
Ramy czasowe: 1 month
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Proportion of participants with OCT-confirmed anatomical macular hole closure.
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1 month
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Macular Hole Closure at 1 Year
Ramy czasowe: 1 year
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Proportion of participants with OCT-confirmed anatomical macular hole closure.
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1 year
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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BCVA at Day 7
Ramy czasowe: 7 days
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Best-corrected visual acuity (BCVA) measured at Day 7 after surgery and recorded in logMAR units.
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7 days
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BCVA at 1 Month
Ramy czasowe: 1 month
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Best-corrected visual acuity (BCVA) measured at 1 month after surgery and recorded in logMAR units.
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1 month
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BCVA at 1 Year
Ramy czasowe: 1 year
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Best-corrected visual acuity (BCVA) measured at 1 year after surgery and recorded in logMAR units.
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1 year
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Sanzhar Sambet Sambet, MD, Kazakh Eye Research Institute
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- IRB-538-2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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