Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction

Официальное название

A Prospective, Multicenter, Open-label, Single-arm Clinical Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) IOL for Correction of Aphakia Following Cataract Extraction

Обзор

A study to learn how well an artificial lens, called an intraocular lens (IOL), works in adults who have cataract surgery. During this type of surgery, the eye's natural lens is removed and replaced with an artificial lens to help restore vision. The main goal of the study is to evaluate vision after the lens is placed in the eye. About one year after surgery, participants' vision will be measured to understand how clearly they can see. The study will also look at how the lens performs over time, including how well it remains in place in the eye. The results of this study will help provide more information about how this lens performs in adults undergoing cataract surgery.

Вмешательства

• Устройство KI-362-US1 (YP2.2VM)
  Injector and one-piece (1P) monofocal IOL

Первичные конечные точки

• Proportion of Participants whose BCDVA Achieved 0.30 logMAR or Better at Form 5 [Срок оценки: Baseline (Form 0) through Visit 5 (Form 5), approximately Days 330-390]
• Proportion of Participants with Incidence of Selected Ocular Adverse Events [Срок оценки: Baseline through end of study (up to 15 months)]

Вторичные конечные точки (4)

• Proportion of Participants with Lens Axis Misalignment of <10 degrees From Baseline to Form 4 [Срок оценки: Baseline (Form 0) through Visit 4 (Form 4), approximately Days 120-180]
• Proportion of Participants with Lens Axis Misalignment of <10 degrees From Baseline to Form 5 [Срок оценки: Baseline (Form 0) through Visit 5 (Form 5), approximately Days 330-390]
• Proportion of Participants with Lens Axis Misalignment of <20 degrees From Baseline to Form 4 [Срок оценки: Baseline (Form 0) through Visit 4 (Form 4), approximately Days 120-180]
• Proportion of Participants with Lens Axis Misalignment of <20 degrees From Baseline to Form 5 [Срок оценки: Baseline (Form 0) through Visit 5 (Form 5), approximately Days 330-390]

Критерии участия

Критерии включения

• Are able and willing to provide written informed consent, attend all scheduled visits, and comply with all trial procedures and follow-up
• Have a study eye with visually significant cataract for which phacoemulsification cataract extraction and posterior chamber IOL implantation is indicated
• Meet all other inclusion criteria outlined in the clinical study protocol

Критерии исключения

• Have serious systemic disease that could increase operative risk or conditions that can confound the surgical outcome
• Within 30 days of the Screening Visit, use of systemic medications with significant ocular side effects or any medications that could confound the outcome or increase participant risk
• Meet any other exclusion criteria outlined in the clinical study protocol

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07650201 · KI-362-US1-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗