Evaluation of Efficacy and Long-term Safety for the InFo - Instant Focus © Lens / PMCF
- Conditions
- Cataract
- Registration Number
- NCT02841670
- Lead Sponsor
- SAV-IOL SA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Near best corrected visual acuity Year 1 Intermediate (80cm) best corrected visual acuity Year 1 Far best corrected visual acuity Year 1 Near uncorrected visual acuity Year 1 Intermediate (80cm) uncorrected visual acuity Year 1 Far uncorrected visual acuity Year 1
- Secondary Outcome Measures
Name Time Method Contrast sensitivity Year 1 Tilting sensitivity Year 1 Decentration sensitivity Year 1 Patient satisfaction Year 1 Questionnaire
Adverse events Year 1 Including Posterior Capsule Opacification rates