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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: InFo - Instant Focus (c) lens implantation

• Study Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Contrast sensitivity		Year 1
Tilting sensitivity		Year 1
Decentration sensitivity		Year 1
Patient satisfaction	Questionnaire	Year 1
Adverse events	Including Posterior Capsule Opacification rates	Year 1

Collaborators and Investigators

• Sponsor: SAV-IOL SA
• Collaborators: CEISO
• Investigators: Principal Investigator: André Mermoud, Prof, Clinique Montchoisi Lausanne

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: July 12, 2016
• First Submitted That Met QC Criteria: July 19, 2016
• First Posted (Estimate): July 22, 2016

Study Record Updates

• Last Update Posted (Actual): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 3, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 2016-00909

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO