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Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After the Second Eye Implant

NCT04801992 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 23

Last updated 2021-03-22

No results posted yet for this study

Summary

The study objective is to evaluate the visual performance of MINI WELL Ready at 24 months following the second eye implant. The objectives of safety are to evaluate the rate of Secondary Surgical Interventions related to the optical properties of the IOL for first and second operative eye separately at 24 months and the rate of visual disturbances and distortions as reported by the subjects as detected by using the Halo \& Glare Simulator.

Conditions

  • Cataract

Interventions

DEVICE

MINI WELL Ready (SIFI SpA, Italy)

Implantation during cataract surgery of the progressive extended depth of focus intraocular lens for the posterior chamber to replace the crystalline lens in the correction of aphakia in adult patients.

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • SIFI SpA

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-26
Primary Completion
2020-11-19
Completion
2020-11-19

Countries

  • Italy

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 NCT04801992 on ClinicalTrials.gov