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

Cataract Clinical Trial

— INFOLO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02841670
• Other study ID #: 2016-00909
• Status: Completed
• Start date: August 2016
• Est. completion date: February 2019

Study information

• Verified date: May 2019
• Source: SAV-IOL SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
SAV-IOL SA	CEISO

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Near best corrected visual acuity		Year 1
Primary	Intermediate (80cm) best corrected visual acuity		Year 1
Primary	Far best corrected visual acuity		Year 1
Primary	Near uncorrected visual acuity		Year 1
Primary	Intermediate (80cm) uncorrected visual acuity		Year 1
Primary	Far uncorrected visual acuity		Year 1
Secondary	Contrast sensitivity		Year 1
Secondary	Tilting sensitivity		Year 1
Secondary	Decentration sensitivity		Year 1
Secondary	Patient satisfaction	Questionnaire	Year 1
Secondary	Adverse events	Including Posterior Capsule Opacification rates	Year 1