Comparative Study of 2 Multifocal Intraocular Lenses in Heidelberg

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: f
View:

• 50 \< Age \< 85 years old

• Bilateral age-related cataract

• Signed informed consent of the study

• Availability, willingness and sufficient cognitive awareness to comply with study procedures

• No previous refractive or ocular surgery

• Need for IOL in this diopter range: 10 to 30 D

• Expected postoperative astigmatism ≤ 0.75 D

• Eye dryness ≤ 2 in dry eye severity grading

• For women of childbearing potential: Willing to adhere to an adequate form of contraception.

Locations
Other Locations
Germany
Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC)
RECRUITING
Heidelberg
Contact Information
Primary
Sylvie Lebeau
s.lebeau.ci@cristalens.fr
+33 (0)2 96 48 92 92
Time Frame
Start Date: 2022-07-17
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 50
Treatments
Active_comparator: ARTIS SYMBIOSE
25 patients will be implanted bilaterally with Artis Symbiose IOLs (Cristalens Industrie, France) . The device is CE-marked and used according to the intended purpose.
Active_comparator: PANOPTIX
25 patients will be implanted bilaterally with AcrySof IQ PanOptix IOLs (Alcon, Switzerland).The device is CE-marked and used according to the intended purpose.
Related Therapeutic Areas
Sponsors
Leads: Cristalens Industrie

This content was sourced from clinicaltrials.gov