Clareon PanOptix Versus AcrySof PanOptix : Prospective Study Comparing Contrast Sensitivity

Official title

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.

Overview

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

• Device Acrysof™ 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
• Device Clareon Panoptix
  both of the patient's eyes will be implanted: 1 CPO and the other APO

Primary outcome measures

• Contrast sensitivity measured at 3 months [Time frame: 3 months]

Secondary outcome measures (5)

• Contrast sensitivity measured at 3 months [Time frame: 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) [Time frame: 3 months]
• Refractive stability [Time frame: 1 and 3 months]
• OSI : Objective Scatter Index: monocular [Time frame: 3 months]
• Glistenings [Time frame: 3 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Other

Study locations

France · 1 center

• Assistance Publique - Hôpitaux de Paris, Ophtalomopôle - Hôpital COCHIN — Paris

Identifiers

NCT: NCT07158177 · APHP241077 · IDRCB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗