Status:
NOT_YET_RECRUITING
Clareon PanOptix Versus AcrySof PanOptix : Prospective Study Comparing Contrast Sensitivity
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Alcon Research
URC-CIC Paris Descartes Necker Cochin
Conditions:
Cataract and IOL Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
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 wi...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07158177
Start Date
September 15 2025
End Date
October 15 2026
Last Update
September 5 2025
Active Locations (1)
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1
Assistance Publique - Hôpitaux de Paris, Ophtalomopôle - Hôpital COCHIN
Paris, Île-de-France Region, France, 75014