Набор скоро начнётся NCT07587138

Clinical Evaluation of a Novel Trifocal IOL

Без фазы С лечением Aphakia Cataract

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: LPYWT0, PXYWT0, Cataract Surgery.
Кому может быть актуально: Состояния в реестре: Aphakia, Cataract. Базовые параметры: от 22 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: Индия, Филиппины
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The purpose of this study is to understand the visual outcomes of the investigational intraocular lens (IOL) Model LPYWT0 when compared to the commercially marketed Clareon PanOptix Pro IOL Model PXYWT0.

Подробное описание

In this study, subjects with cataracts in both eyes will undergo cataract surgery and be implanted with trifocal IOLs. One eye will receive the investigational IOL Model LPYWT0 IOL, and the other eye will receive the commercially marketed Clareon PanOptix Pro IOL Model PXYWT0. The second eye surgery will occur 7-14 days after the first. Subjects will attend 9 planned study visits to include for an individual duration of participation of approximately 7 months.

This study is planned to be conducted in India and the Philippines.

Вмешательства

Устройство LPYWT0
Investigational blue light filtering trifocal IOL implanted in the capsular bag of the eye during cataract surgery intended to remain in the eye for the lifetime of the subject.
Устройство PXYWT0
Commercially available blue light filtering trifocal IOL implanted in the capsular bag of the eye during cataract surgery intended to remain in the eye for the lifetime of the subject.
Процедура Cataract Surgery
Removal of the cataractous lens by phacoemulsification followed by implantation of the IOL

Первичные конечные точки

Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) [Срок оценки: Month 6 postoperative]

Критерии участия

Критерии включения

The calculated power needed for the artificial lens (IOL) must be between +15.0 and +25.0 D in each eye, designed to bring subject vision as close to "0.0" (neutral) as possible, meaning they will not be strongly nearsighted or farsighted after surgery.
Subjects must have low levels of astigmatism (misshapen cornea) in the eyes (less than 1.00 D).
In the doctor's opinion, the subjects have the potential to achieve good vision (0.2 logMAR, which is roughly 20/32 Snellen or better) in each eye after the surgery, when wearing the best possible spectacles or contact lenses.
Other protocol-specified inclusion criteria may apply.

Критерии исключения

Clinically significant corneal diseases which may, according to the investigator's medical opinion, adversely affect visual outcomes.
Any ocular or systemic health condition or medical issue that, in the investigator's medical opinion, could make the study results unreliable, prevent the person from finishing the study, or increase their safety risk.
People who want to have one eye set for distance vision and the other for near vision.
The doctor expects significant blurry vision (astigmatism) after the procedure.
Other protocol-specified exclusion criteria may apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет