Идёт набор NCT07452042

Postoperative Outcomes of a Toric AddOn Intraocular Lens After Keratoplasty and Cataract Surgery

— Наблюдательное Cataract and IOL Surgery Keratoplasty Toric Intraocular Lens Stability

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: AddOn toric IOL implantation.
Кому может быть актуально: Состояния в реестре: Cataract and IOL Surgery, Keratoplasty, Toric Intraocular Lens Stability. Базовые параметры: 45 лет — 95 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: Австрия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Postoperative Outcomes of a Toric Add-On Intraocular Lens After Keratoplasty and Cataract Surgery

Обзор

The aim of this clinical study is to evaluate a toric add-on intraocular lens (IOL) for the correction of high astigmatism in patients who have undergone keratoplasty and cataract surgery. As this patient group often suffers from significant preoperative residual astigmatism, there is a relevant clinical need for effective and safe refractive treatment options. The implantation of a toric add-on IOL in the ciliary sulcus is intended to significantly reduce postoperative astigmatism and improve visual rehabilitation. The study is designed as a prospective, monocentric clinical trial with a limited number of cases, as this is a rare condition with limited availability of suitable patients. It is being conducted in accordance with Section 3 of the Austrian Medical Devices Act (MPG 2021) and is investigating a CE-marked add-on intraocular lens implant used within its intended purpose. The postoperative refractive cylinder serves as the primary endpoint, as it reflects the actual effectiveness of astigmatism correction. The rotational stability of the add-on IOL, which significantly influences refractive precision, is recorded as a secondary endpoint. All study participants will be examined pre- and postoperatively in accordance with applicable medical standards. The results should contribute to the optimization of refractive care after keratoplasty and assess the clinical applicability of toric AddOn IOLs in this specific indication.

Вмешательства

Процедура AddOn toric IOL implantation
Implantation of a toric AddOn IOL in the ciliary sulcus of patients after cataract surgery and keratoplasty with a high postoperative refractive cylinder.

Первичные конечные точки

Mean Postoperative Refractive Cylinder (Diopters) [Срок оценки: 4-7 months]

Вторичные конечные точки (4)

Mean Absolute IOL Rotation from Intended Axis (Degrees) [Срок оценки: 4-7 months]
Mean IOL Decentration (Millimeters) [Срок оценки: 4-7 months]
Mean IOL Tilt (Degrees) [Срок оценки: 4-7 months]
Mean Axial Position Change of IOL (Millimeters) [Срок оценки: 4-7 months]

Критерии участия

Критерии включения

Gender: female, male, or diverse
Ophthalmological diagnosis: pseudophakic patients after keratoplasty
Age: 45 to 90 years
Complication-free cataract surgery using phacoemulsification and implantation of a posterior chamber lens.
Complication-free keratoplasty and regular postoperative corneal astigmatism > 1 diopter (D)
Pupil diameter in mydriasis > 5.5 mm