Clareon PanOptix Versus AcrySof PanOptix : Prospective Study Comparing Contrast Sensitivity

Официальное название

Clareon PanOptix Versus AcrySof PanOptix : Prospective Study Comparing Contrast Sensitivity. Study of Two Different Material of Intra Ocular Multifocal Lenses Aiming to Compare the Effect on Contrast Sensitivity.

Обзор

Retrospective, comparative, interventional, randomized, single-center study, contralateral (the patient's 2 eyes will be implanted: 1 CPO and the other APO) Patients presenting for cataract surgery with a request for presbyopia correction and managed as part of routine clinical practice. The main aim of the study is to demonstrate that contrast sensitivity is better with the Clareon PanOptix (CPO) intraocular lens (IOL) compared with the AcrySof PanOptix (APO) IOL 3 months after implantation.

Подробное описание

Visit at Day3-10: usual follow-up visit, no additional examinations as part of the clinical investigation.

Visit at 1 month: usual follow-up visit, no additional examinations as part of the clinical investigation.

3-month visit (end of clinical investigation): usual follow-up visit, plus contrast vision test and non-invasive aberrometry test (I-Trace) as part of the clinical investigation.

Regarding a cataract surgery with a request for presbyopia, the protocol evaluate two differents devices (IOL intraocular lens).

Вмешательства

• Устройство Acrysof™ PanOptix™ toric or not, trifocal IOL CE marked, Alcon company.
  both of the patient's eyes will be implanted: 1 CPO and the other APO
• Устройство Clareon Panoptix
  both of the patient's eyes will be implanted: 1 CPO and the other APO

Первичные конечные точки

• Contrast sensitivity measured at 3 months [Срок оценки: 3 months]

Вторичные конечные точки (5)

• Contrast sensitivity measured at 3 months [Срок оценки: 3 months]
• Uncorrected and corrected Visual acuity (UCVA and CVA) or in monocular and binocular vision at different distances (4 meters for Distance- 66 centimeters of intermediate- 40 cm for Near) [Срок оценки: 3 months]
• Refractive stability [Срок оценки: 1 and 3 months]
• OSI : Objective Scatter Index: monocular [Срок оценки: 3 months]
• Glistenings [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Patients ≥ 18 years of age
• Patients presenting for cataract surgery in routine clinical practice and eligible for multifocal IOL implantation (toric and non-toric)
• Patients with grade 2/3 cataract density and comparable visual acuity in both eyes
• Patient with a pregnancy test (negative pregnancy test), if applicable
• Patient with signed consent to participate in the study
• Patient affiliated to a social security scheme or entitled beneficiary

Критерии исключения

• Children < 18 years of age
• Pregnancy or breast-feeding in progress or planned during the study.
• History of anterior (cornea, anterior chamber, sulcus) or posterior (uveal, vitreoretinal) segment pathology, including retinal vascular occlusive disease, retinal detachment or peripheral retinal laser photocoagulation, AMD, glaucoma.
• Any inflammation of the anterior or posterior segment, whatever the etiology, and/or history of any disease with intraocular inflammatory repercussions.
• Clinically significant corneal pathology (epithelial, stromal and/or endothelial) that could have an impact on visual results.
• Clinically significant moderate or severe dry eye that could affect study measurements.
• History of intraocular or corneal surgery (refractive or trauma-related).
• Presence or history of amblyopia or monofixation syndrome.
• Subjects with conditions that increase the risk of zonular disruption during the phacoemulsification procedure that may affect the centration or postoperative orientation of the IOL.
• Any other planned eye surgery, including, but not limited to, limbal relaxing incision (LRI)/astigmatic keratotomy and laser refractive surgery (LASIK).
• Irregular astigmatism identified by corneal topography
• Patients under guardianship, curatorship or safeguard of justice, as well as pregnant or breast-feeding women (article L1121-5 of the CSP).1.1
• Patient under AME

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Assistance Publique - Hôpitaux de Paris, Ophtalomopôle - Hôpital COCHIN — Paris

Идентификаторы

NCT: NCT07158177 · APHP241077 · IDRCB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗