Clareon PanOptix Versus AcrySof PanOptix : Prospective Study Comparing Contrast Sensitivity

NCT07158177 | Recruiting

• 2 other identifiers: APHP241077IDRCB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract and IOL Surgery

Keywords

Multifocal Intra Ocular Lens; Presbyopia Correcting Intra Ocular Lens (PCIOL).; Cataract

Outcome Measures

Primary Outcomes (1)

• Contrast sensitivity measured at 3 months

  AULCSF (Area under the log contrast sensitivity function) at different spatial frequencies (1,5 ; 3 ; 6 ; 12 cycles par degré (cpd)) in monocular vision and under mesopic condition without glare.

  3 months

Secondary Outcomes (5)

• Contrast sensitivity measured at 3 months

  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)

  3 months

• Refractive stability

  1 and 3 months

• OSI : Objective Scatter Index: monocular

  3 months

• Glistenings

  3 months

Study Arms (2)

Clareon™ PanOptix™, toric or no-toc

EXPERIMENTAL

Device: Clareon Panoptix

AcrySof™ IQ PanOptix™, toric or no-toric

ACTIVE COMPARATOR

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

Interventions

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

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

AcrySof™ IQ PanOptix™, toric or no-toric

Clareon Panoptix DEVICE

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

Clareon™ PanOptix™, toric or no-toc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead
• Alcon Research: collaborator

Study Sites (1)

Assistance Publique - Hôpitaux de Paris, Ophtalomopôle - Hôpital COCHIN

Paris, Île-de-France Region, 75014, France

RECRUITING

Related Links

• This web link leads to the website of SAFIR, which is a French learned society dedicated to refractive and cataract surgery with implants. It contains an educational section on multifocal implants and cataract surgery to better understand the protocol.

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Dominique MONNET, MD, PhD

  Université Paris Cité, Faculté de Santé / UFR de médecine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique MONNET, MD, PhD

CONTACT

01 58 41 22 01; dominique.monnet@aphp.fr

Valérie PLENCE, MSc

CONTACT

valerie.plence-fauroux@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)