Идёт набор NCT05561478

Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric

— Наблюдательное Cataract Surgery IOL

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Implantation of Synthesis Plus IOL (control device), Implantation of Synthesis Plus Toric IOL (investigational device).
Кому может быть актуально: Состояния в реестре: Cataract, Surgery, IOL. Базовые параметры: от 50 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Prospective controlled monocentric study to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the SYNTHESIS PLUS TORIC with respect to the SYNTHESIS PLUS IOL.

Вмешательства

Устройство Implantation of Synthesis Plus IOL (control device)
Synthesis Plus IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients.
Устройство Implantation of Synthesis Plus Toric IOL (investigational device)
Synthesis Plus Toric IOLs are indicated for primary implantation for the visual correction of aphakia in adult patients with pre-existing astigmatism.

Первичные конечные точки

DCIVA at 66 cm [Срок оценки: 1 month]

Вторичные конечные точки (8)

Monocular UDVA [Срок оценки: 1 month]
Monocular BCDVA [Срок оценки: 1 month]
Monocular UIVA [Срок оценки: 1 month]
Monocular DCIVA [Срок оценки: 1 month]
Refraction [Срок оценки: 1 month]
Potential complications [Срок оценки: 1 month]
Rotational stability [Срок оценки: Peroperatively, day 0, Month 1]
Subjective quality of vision [Срок оценки: 1 month]

Критерии участия

Критерии включения

Patient older than 50 years old
Patient requiring bilateral cataract surgery
Regular corneal astigmatism >0.5D measured by MS-39 (SimK keratometry and regularity determined by the topography) for patients implanted with SYNTHESIS PLUS TORIC or Regular corneal astigmatism lower or equal to 0.5 D dioptres by MS-39 (SimK keratometry and regularity determined by the topography) for patients implanted with SYNTHESIS PLUS.
Expected postoperative astigmatism ≤ 0.75D diopter
Corneal astigmatism ≤4D
IOL spherical equivalent power requested between 15D and 25D
Signed informed consent
Availability, willingness and sufficient cognitive awareness to comply with examination procedures

Non inclusion Criteria:

Patients with a potential postoperative visual acuity of less than 5/10, in particular due to degenerative visual disorders, poor retinal function or a damaged cornea.
Amblyopia with a visual acuity potential of less than 5/10
IOL power needed outside the spherical equivalent diopter range: 15 to 25D
Difficulty for cooperation (distance from their home, general health condition)
Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
Irregular astigmatism
Subject with postoperative astigmatism, expected > 0.75 D.
Any ocular comorbidity
History of ocular trauma or prior ocular surgery including refractive procedures
Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
Patients with chronic uveitis
Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions, diameter (pupil>4mm or <2.5 mm in photopic conditions))
Narrow anterior chambers (ACD ≤ 2.5 mm)
Any corneal pathology potentially affecting the topography (eg. Keratoconus),
Monophthalma patients
Phacodonesis