Clareon PanOptix Versus AcrySof PanOptix : Prospective Study Comparing Contrast Sensitivity (CLAYRE)

Assistance Publique - Hôpitaux de Paris

Status

Not yet enrolling

Conditions

Cataract and IOL Surgery

Treatments

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

Device: Clareon Panoptix

Study type

Interventional

Funder types

Other

Identifiers

NCT07158177

APHP241077

IDRCB (Other Identifier)

Details and patient eligibility

About

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.

Full description

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).

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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