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NCT06327347Recruiting

Comparative Study of 2 Multifocal Intraocular Lenses in Heidelberg

Cristalens IndustrieClinicalTrials.govdeviceDevice trial
Verified
Study focus
Disease/Condition
Cataract
Drug/Device/Intervention
intraocular lens implantation in cataract surgery
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Cristalens Industrie
Location
Heidelberg, Germany
Timeline & enrollment
Phase
N/A
Start date
Jul 17, 2022
End date
Jul 31, 2026
Enrollment
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 cataractCataract, unspecifiedComplicated cataractOther specified cataractSenile cataract
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06327347
Type
Device Trial
About this record

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.