NCT06105190

Clinical Study to Evaluate Clinical Outcomes of LuxSmart IOL as Compared With LuxGood IOL

Prospective, Multicenter, Controlled, Randomized, Masked Study to Evaluate the Safety and Performance of LuxSmart IOL as Compared With LuxGood IOL In Subjects Undergoing Cataract Extraction

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Cutting Edge SAS · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

This study is a multicentric, prospective, randomised, controlled, post-market clinical follow up (PMCF) study to investigate safety, visual outcomes and contrast sensitivity after bilateral implantation of either LuxSmart IOLs (study group) or LuxGood IOLs (control group).

Detailed description

This study is a multicentric, prospective, randomised, controlled, post-market clinical follow up (PMCF) study whereby subjects undergoing routine cataract surgery will have bilateral implantation of either LuxSmart IOLs (study group) or LuxGood IOLs (control group). The subjects will be randomized in a 1:1 ratio to receive the study or control lenses. Both study and control IOLs, are CE approved The study and control IOLs, and all devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the subject. The study device (LuxSmart) is a hydrophobic, premium monofocal intraocular lens (IOL) manufactured by the sponsor of this study. The control lens (LuxGood) is the monofocal parent lens sharing the same material and optic design but with slight differences in the optic design. The IOLs will be implanted as part of the routine cataract surgery on subjects suffering from cataract. The targeted study cohort represents the standard subject cohort for cataract surgery. In total 238 subjects will be enrolled for this clinical study and receive bilateral implantation of the study or control lens based on a 1:1 randomization given by the EDC. Subjects participating in the trial will attend a total of 6 to 10 study visits (1 preoperative, 1 or 2 operative and 4 - 7 postoperative visits that may be carried out at the same day if requirements allow) over a period of 6 months. Data analyses will be performed after the last patient finished the 120-180 days postoperative examination.

Conditions

• Cataract
• Lens Opacities

Interventions

Type	Name	Description
DEVICE	Implantation of premium monofocal IOL, LuxSmart (device under investigation)	Patients will be implanted with study IOL in both eyes
DEVICE	Implantation of monofocal IOL, LuxGood (control device)	Patients will be implanted with Control IOL in both eyes

Timeline

• Start date: 2023-06-21
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2023-10-27
• Last updated: 2025-02-12

Locations

8 sites across 6 countries: Austria, Czechia, Germany, Philippines, Singapore, Spain