Cataract and IOL Surgery
Conditions
Keywords
Multifocal Intra Ocular Lens, Presbyopia Correcting Intra Ocular Lens (PCIOL)., Cataract
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 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.
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 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).
Interventions
DEVICEAcrysof™ PanOptix™ toric or not, trifocal IOL CE marked, Alcon company.
both of the patient's eyes will be implanted: 1 CPO and the other APO
DEVICEClareon Panoptix
both of the patient's eyes will be implanted: 1 CPO and the other APO
Sponsors
Assistance Publique - Hôpitaux de Paris
Alcon Research
URC-CIC Paris Descartes Necker Cochin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contrast sensitivity measured at 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Contrast sensitivity measured at 3 months | 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) | 3 months | UDVA, UIVA, UNVA, BCDVA, DCIVA, DCNVA |
| Refractive stability | 1 and 3 months | Comparison of refractive error between 1 and 3 months |
| OSI : Objective Scatter Index: monocular | 3 months | Comparison of refractive error between 1 and 3 months |
| Glistenings | 3 months | Using Miyata scale |
Countries
France
Contacts
CONTACTDominique MONNET, MD, PhD
CONTACTValérie PLENCE, MSc
PRINCIPAL_INVESTIGATORDominique MONNET, MD, PhD
Université Paris Cité, Faculté de Santé / UFR de médecine
Outcome results
None listed