Comparative Study of 3 Multifocal Intraocular Lenses in Murcia

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 3 intraocular lenses (IOLs): FineVision (comparator), ARTIS SYMBIOSE (study lenses), and Tecnis Synergy (comparator) through binocular distance-corrected defocus curve. This main objective will be to show superiority of the ARTIS SYMBIOSE system through binocular distance-corrected defocus curve. 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 examination procedures

• Qualify for bilateral implantation within 1 month

• 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

Locations
Other Locations
Spain
Vista Clinic Ircovision Murcia
RECRUITING
Murcia
Contact Information
Primary
Sylvie Lebeau
s.lebeau.ci@cristalens.fr
+33 (0)2 96 48 92 92
Time Frame
Start Date: 2021-04-20
Estimated Completion Date: 2025-09-20
Participants
Target number of participants: 84
Treatments
Active_comparator: FineVision
28 patients will be implanted bilaterally with Intensity FineVision (PhysIOL, Belgium) trifocal IOLs.~The device is CE-marked and used according to the intended purpose.
Active_comparator: Artis Symbiose
28 patients will be implanted bilaterally with Artis Symbiose (Cristalens Industrie, France) IOLs.~The device is CE-marked and used according to the intended purpose.
Active_comparator: Synergy
28 patients will be implanted bilaterally with Tecnis Synergy model ZFR00V (Johnson \& Johnson, USA) IOLs.~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