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NCT Number: NCT07158177

Clareon PanOptix Versus AcrySof PanOptix : Prospective Study Comparing Contrast Sensitivity

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique - Hôpitaux de Paris, Ophtalomopôle - Hôpital COCHIN

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

Location status: Recruiting

Location contact

Dominique MONNET, MD, PhD

CONTACT

[email protected]

01 58 41 22 01 ext. +33

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Clareon Panoptix

Device

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

Primary outcomes

  1. Contrast sensitivity measured at 3 months

    Time frame: 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.

Secondary outcomes

  1. Contrast sensitivity measured at 3 months

    Time frame: 3 months

    AULCSF monocular in photopic condition with and without glareat 3 months.

  2. 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)

    Time frame: 3 months

    UDVA, UIVA, UNVA, BCDVA, DCIVA, DCNVA

  3. Refractive stability

    Time frame: 1 and 3 months

    Comparison of refractive error between 1 and 3 months

  4. OSI : Objective Scatter Index: monocular

    Time frame: 3 months

    Comparison of refractive error between 1 and 3 months

  5. Glistenings

    Time frame: 3 months

    Using Miyata scale

Study contacts

Contact information is provided by the study sponsor or research team.

Dominique MONNET, MD, PhD

CONTACT

[email protected]

01 58 41 22 01 ext. +33

Valérie PLENCE, MSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Alcon Research
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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.

Acronym: CLAYRE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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