Evaluation of Efficacy and Long-term Safety for the InFo - Instant Focus © Lens / PMCF
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- SAV-IOL SA
- Enrollment
- 30
- Primary Endpoint
- Near best corrected visual acuity
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Near best corrected visual acuity
Time Frame: Year 1
Intermediate (80cm) best corrected visual acuity
Time Frame: Year 1
Far best corrected visual acuity
Time Frame: Year 1
Near uncorrected visual acuity
Time Frame: Year 1
Intermediate (80cm) uncorrected visual acuity
Time Frame: Year 1
Far uncorrected visual acuity
Time Frame: Year 1
Secondary Outcomes
- Contrast sensitivity(Year 1)
- Tilting sensitivity(Year 1)
- Decentration sensitivity(Year 1)
- Patient satisfaction(Year 1)
- Adverse events(Year 1)