Clareon PanOptix versus AcrySof PanOptix for contrast vision after cataract surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In a randomized, contralateral design, each participant receives one Clareon PanOptix IOL in one eye and one AcrySof PanOptix IOL in the other during routine cataract surgery. Follow-up visits occur at day 3–10 and 1 month with standard care, and the primary 3-month visit includes contrast sensitivity testing and non-invasive aberrometry (I-Trace). Both toric and non-toric trifocal lenses are allowed, and patients are managed at a single center in Paris. The protocol focuses on contrast vision differences between the two CE-marked IOLs in otherwise healthy eyes eligible for multifocal implantation.

Why it matters

Who can join: the full rules

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

Where it's running

• Assistance Publique - Hôpitaux de Paris, Ophtalomopôle - Hôpital COCHIN
  Paris, Île-de-France Region, France Recruiting

Study contacts

• Principal investigator: Dominique MONNET, MD, PhD — Université Paris Cité, Faculté de Santé / UFR de médecine
• Study coordinator: Dominique MONNET, MD, PhD
• Email: dominique.monnet@aphp.fr
• Phone: 01 58 41 22 01

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.