About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Acrysof™ PanOptix™ toric or not, trifocal IOL CE marked, Alcon company.
Deviceboth of the patient's eyes will be implanted: 1 CPO and the other APO
Clareon Panoptix
Deviceboth of the patient's eyes will be implanted: 1 CPO and the other APO
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Contrast sensitivity measured at 3 months
AULCSF monocular in photopic condition with and without glareat 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)
UDVA, UIVA, UNVA, BCDVA, DCIVA, DCNVA
Refractive stability
Comparison of refractive error between 1 and 3 months
OSI : Objective Scatter Index: monocular
Comparison of refractive error between 1 and 3 months
Sponsors and contacts
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
Alcon Research
Collaborator
URC-CIC Paris Descartes Necker Cochin
Collaborator