Horizontal vs Vertical Scleral Tunnels in Flanged IOL Fixation (HORVER)
Horizontal Versus Vertical Scleral Tunnel Orientation in Flanged Intrascleral Fixation: A 2-Year Comparative Study
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Background: The management of aphakia, crystalline lens luxation, and intraocular lens (IOL) luxation in the absence of adequate capsular support remains challenging. Traditional surgical options include anterior chamber IOLs, iris-fixated IOLs, and scleral-sutured posterior chamber IOLs, each carrying significant long-term risks. In 2017, Yamane and colleagues introduced a sutureless flanged intrascleral IOL fixation technique that rapidly gained worldwide acceptance. A critical yet under-investigated surgical variable is the orientation of the scleral tunnels relative to the limbus. Some surgeons create tunnels parallel to the limbus (horizontal/tangential), others perpendicular (vertical/radial), based on personal preference rather than high-level evidence.
Objective: To evaluate whether horizontal versus vertical scleral tunnel orientation is associated with differing 2-year outcomes in flanged intrascleral IOL fixation.
Study Design: This is a retrospective observational cohort study conducted at a single tertiary referral centre.
Participants: A total of 107 eyes (43 vertical tunnels, 64 horizontal tunnels) with complete 24-month follow-up are included. Surgeries are performed by two experienced vitreoretinal surgeons.
Interventions: All procedures follow the original Yamane flanged intrascleral fixation method with intentional variation in tunnel orientation only. The horizontal tunnel group receives tunnels parallel to the limbus (tangential), while the vertical tunnel group receives tunnels perpendicular to the limbus (radial). A three-piece foldable acrylic IOL (Alcon AcrySof MA60AC) is used in all eyes.
Outcome Measures: The primary outcome is the proportion of eyes achieving mean absolute error (MAE) within ±0.50D of target refraction at 2 years. Secondary outcomes include MAE at 2 years, IOL tilt measured using anterior segment optical coherence tomography (AS-OCT), iris capture, conjunctival erosion, cystoid macular oedema, epiretinal membrane, retinal detachment, vitreous haemorrhage, hypotony, corneal oedema, early IOP elevation, best-corrected visual acuity (BCVA), and vector astigmatism analysis using the Alpins method.
Statistical Analysis: Propensity score matching (1:1) will be performed to address selection bias. Multivariate logistic regression and a multilevel mixed-effects model with surgeon as random effect will be used to adjust for confounders including surgical period, age, and baseline refraction. For the primary outcome, a single pre-specified comparison will be made with a two-tailed significance level of α = 0.05. For secondary outcomes, the False Discovery Rate (FDR) using the Benjamini-Hochberg procedure (q = 0.05) will be applied to control for Type I error inflation.
Timeline: Data were collected from patients who underwent surgery between March 1, 2022, and March 1, 2025. Minimum follow-up is 24 months, with final data collection completed in March 2025.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Van, Turcja (Türkiye), 65000
- SBU Van Training and Research Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- Age ≥ 18 years
- Complicated aphakia defined as absence of adequate capsular support following cataract extraction, lens trauma, or previous lensectomy
- Crystalline lens luxation defined as partial or complete displacement of the natural lens due to zonular weakness
- Intraocular lens (IOL) luxation defined as partial or complete dislocation of a previously implanted IOL
- Inadequate capsular support (<180° of intact zonular or capsular support)
- Ability to complete scheduled follow-up visits
- Complete follow-up data available
Exclusion Criteria:
- Previous scleral buckling surgery within 6 months
- Pars plana vitrectomy within 3 months
- Active uveitis
- Active endophthalmitis
- Uncontrolled scleritis or scleral thinning
- Corneal decompensation (endothelial cell density <1000 cells/mm²)
- Uncontrolled glaucoma (IOP >25 mmHg despite maximum therapy)
- History of penetrating keratoplasty, DALK, DSEK, or DMEK
- History of corneal refractive surgery
- Active proliferative diabetic retinopathy
- Pregnancy or breastfeeding
- Inability to complete 24-month follow-up
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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Vertical Scleral Tunnel Group
Patients who underwent flanged intrascleral IOL fixation with scleral tunnels created perpendicular to the limbus (radial/vertical orientation).
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Sutureless flanged intrascleral fixation of a three-piece foldable acrylic IOL (Alcon AcrySof MA60AC).
Two partial-thickness scleral tunnels are created 2.0 mm posterior to the limbus, 180° apart.
Haptics are externalized through the tunnels, and a flange is created on each haptic tip using thermal cautery.
Tunnel orientation varied intentionally: horizontal (parallel to limbus) or vertical (perpendicular to limbus).
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Horizontal Scleral Tunnel Group
Patients who underwent flanged intrascleral IOL fixation with scleral tunnels created parallel to the limbus (tangential/horizontal orientation).
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Sutureless flanged intrascleral fixation of a three-piece foldable acrylic IOL (Alcon AcrySof MA60AC).
Two partial-thickness scleral tunnels are created 2.0 mm posterior to the limbus, 180° apart.
Haptics are externalized through the tunnels, and a flange is created on each haptic tip using thermal cautery.
Tunnel orientation varied intentionally: horizontal (parallel to limbus) or vertical (perpendicular to limbus).
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Proportion of Eyes Achieving Mean Absolute Error (MAE) Within ±0.50 Diopters of Target Refraction
Ramy czasowe: 24 Months
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The proportion of eyes achieving mean absolute error (MAE) within ±0.50 diopters of the target spherical equivalent refraction at 24 months postoperatively.
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24 Months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Mean Absolute Error (MAE) at 2 Years
Ramy czasowe: 24 Months
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Mean absolute error in spherical equivalent refraction at 24 months postoperatively.
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24 Months
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IOL Tilt Angle
Ramy czasowe: 24 Months
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Intraocular lens tilt angle measured using anterior segment optical coherence tomography (AS-OCT) at 24 months postoperatively.
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24 Months
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
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
Inne numery identyfikacyjne badania
- GOKAEK-2024-04-02 (Inny identyfikator: Van Training and Research Hospital Ethics Committee)
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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