Clareon PanOptix versus AcrySof PanOptix for contrast vision after cataract surgery
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.
NA · Assistance Publique - Hôpitaux de Paris · NCT07158177
This study will try Clareon PanOptix in one eye and AcrySof PanOptix in the other to see which lens gives better contrast vision three months after cataract surgery for adults seeking presbyopia correction.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris, Île-de-France Region) |
| Trial ID | NCT07158177 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) presenting for cataract surgery who want presbyopia-correcting trifocal IOLs, have comparable cataract density in both eyes, and have no significant ocular comorbidities are ideal candidates.
Not a fit: Patients with retinal disease, glaucoma, prior significant anterior or posterior segment pathology, active intraocular inflammation, pregnancy, or those unsuitable for multifocal IOLs are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, the results could help surgeons choose the IOL that provides better contrast vision and overall visual quality for patients wanting presbyopia correction.
How similar studies have performed: Previous comparisons of trifocal and multifocal IOLs have shown similar acuity outcomes with mixed or modest differences in contrast sensitivity, so this contralateral randomized comparison builds on existing but not definitive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Paris, Île-de-France Region
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cataract and IOL Surgery, Multifocal Intra Ocular Lens, Presbyopia Correcting Intra Ocular Lens., Cataract