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Comparative Study of 2 Multifocal Intraocular Lenses in Heidelberg - Trial NCT06327347

Access comprehensive clinical trial information for NCT06327347 through Pure Global AI's free database. This phase not specified trial is sponsored by Cristalens Industrie and is currently Recruiting. The study focuses on Cataract. Target enrollment is 50 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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Trial Details
ClinicalTrials.gov โ€ข NCT06327347
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Comparative Study of 2 Multifocal Intraocular Lenses in Heidelberg

Study Focus

Cataract

intraocular lens implantation in cataract surgery

Interventional

device

Sponsor & Location

Cristalens Industrie

Heidelberg, Germany

Timeline & Enrollment

N/A

Jul 17, 2022

Jul 31, 2026

50 participants

Primary Outcome

Binocular Distance Corrected Intermediate Visual Acuity

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.

ICD-10 Classifications

Other cataract
Cataract, unspecified
Complicated cataract
Other specified cataract
Senile cataract

Data Source

ClinicalTrials.gov

NCT06327347

Device Trial