Clareon PanOptix Versus AcrySof PanOptix : Prospective Study Comparing Contrast Sensitivity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2026-10-15

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Cataract and IOL Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Clareon™ PanOptix™, toric or no-toc

Group Type EXPERIMENTAL

Clareon Panoptix

Intervention Type DEVICE

both of the patient's eyes will be implanted: 1 CPO and the other APO

AcrySof™ IQ PanOptix™, toric or no-toric

Group Type ACTIVE_COMPARATOR

Acrysof™ PanOptix™ toric or not, trifocal IOL CE marked, Alcon company.

Intervention Type DEVICE

both of the patient's eyes will be implanted: 1 CPO and the other APO

Interventions

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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

Intervention Type DEVICE

Clareon Panoptix

both of the patient's eyes will be implanted: 1 CPO and the other APO

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No