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Evaluation of Efficacy and Long-term Safety for the InFo - Instant Focus © Lens / PMCF

NCT02841670 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2019-05-06

No results posted yet for this study

Summary

This is a monocentric, longitudinal, prospective, observational post-market follow-up study.

30 patients with a cataract will receive an InFo - Instant Focus © lens implant. After the cataract procedure, data collection will take place during visits planned by the physician as part of normal follow-up.

Patients with cataract will be recruited from the clinic by the investigator based on the inclusion and exclusion criteria.

The patient will be followed up after one day, one week, one month, six months, one year and three years post-op. An interim analysis will be performed with one-year clinical results.

The main objective of the study is to evaluate is to evaluate efficacy and long-term safety for the InFo - Instant Focus © lens.

Conditions

  • Cataract

Interventions

DEVICE

InFo - Instant Focus (c) lens implantation

Sponsors & Collaborators

  • CEISO

    collaborator INDUSTRY

  • SAV-IOL SA

    lead INDUSTRY

Principal Investigators

  • André Mermoud, Prof · Clinique Montchoisi Lausanne

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-12-31
Completion
2019-02-28

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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 NCT02841670 on ClinicalTrials.gov