Prospective Post-Market Clinical Follow-Up (PMCF) Study to Investigate the Clinical Outcomes of a ISOPURE and EYHANCE Intraocular Lenses (IOL)

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

This is a prospective randomised open-label study with the aim to compare the visual performance of the premium monofocal Isopure IOL versus the extended depth of focus Eyhance® IOL after phaco-emulsification cataract surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: t
View:

• Cataractous eyes with no comorbidity;

• Calculated IOL power is within the range of the study IOLs;

• Male or female adults ages 50 years or older on the day of screening who have cataract(s) in one or both eyes;

• Regular total corneal astigmatism ≤1.0 D (measured by topography method)

• Clear intraocular media other than cataract;

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

• Expected postoperative Best Corrected Distance Visual Acuity (CDVA) ≤ 0.2 logMAR;

• Signed informed consent.

Locations
Other Locations
Switzerland
Eye center Vista Alpina
Visp
Time Frame
Start Date: 2023-08-31
Completion Date: 2025-03-12
Participants
Target number of participants: 70
Treatments
Experimental: IOL implantation experimental
Experimental arm: Premium monofocal intraocular lens.
Active_comparator: IOL implantation active comparator
Comparator arm: EDOF intraocular lens.
Related Therapeutic Areas
Sponsors
Collaborators: targomedGmbH
Leads: Beaver-Visitec International, Inc.

This content was sourced from clinicaltrials.gov