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RECRUITING
NCT06327347
NA

Comparative Study of 2 Multifocal Intraocular Lenses in Heidelberg

Sponsor: Cristalens Industrie

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to compare the performance of 2 intraocular lenses (IOLs): ARTIS SYMBIOSE (study lenses) vs PANOPTIX (comparator) through binocular Distance Corrected Intermediate Visual Acuity (DCIVA) assessed at 80 cm in photopic conditions at minimum 1-month post-operative by a blinded evaluator. This main objective will be to show superiority of the ARTIS SYMBIOSE system on the primary endpoint. The patient population to be included is patient suffering from cataract who requires cataract surgery procedure that meet the inclusion and non-inclusion criteria and provide written informed consent. Participants will attend a total of 5 study visits: 1 preoperative visit, 1 surgery visit and 3 postoperative visits.

Key Details

Gender

All

Age Range

50 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2022-07-17

Completion Date

2026-07-31

Last Updated

2024-03-25

Healthy Volunteers

No

Conditions

Interventions

DEVICE

intraocular lens implantation in cataract surgery

Implantation of intra ocular lenses in both patient's eyes in remplacement of the natural cataracted cristallin that has been removed from the patient's eye during the cataract surgery

Locations (1)

Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC)

Heidelberg, Germany