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

Swiss Advanced Vision - Intraocular Lens (SAV-IOL)

Status: Completed

Conditions: Cataract

Treatments: Device: InFo - Instant Focus (c) lens implantation

Study type: Observational

Funder types: Industry

Identifiers

NCT02841670

2016-00909

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• Suffering from cataract
• Physician has made the decision to implant on InFo - Instant Focus © lens
• Age ≥ 18 years, of either sex
• Having given written informed consent, prior to any procedure

Non inclusion criteria:

• Presenting with an astigmatism of >1.00D
• Presenting contraindications for the implantation of an intraocular lens
• Presenting an ophthalmic disorder liable to interfere with study endpoints
• History of previous intraocular surgery in the study eye in the previous 6 months
• Refusing or unable to comply with the follow-up schedule
• Participation in other interventional therapeutic trial at time of inclusion
• Pregnant, breastfeeding, or unable to understand the character and individual consequences of the investigation