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Patients Outcomes of a Monofocal Intraocular Lens Designed for Monovision

NCT06528678 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 51

Last updated 2024-07-30

No results posted yet for this study

Summary

The rationale for this observational study of a CE-marked lens is to prospectively assess the performance, safety, and patient satisfaction in a group of subjects undergoing cataract surgery with bilateral implantation of the RayOne EMV in a monovision configuration. In order to increase the evidence collected from real-world clinical data we are running a multicentre clinical study in several clinics of the Baviera Ophthalmological Group.

Study design: prospective, observational, non-comparative.

Conditions

  • Cataract

Interventions

DEVICE

Intraocular lens

Lens exchange with an intraocular lens

Sponsors & Collaborators

  • Clinica Baviera

    lead OTHER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2023-06-12
Completion
2023-10-24
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06528678 on ClinicalTrials.gov