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

NCT02841670 | Completed

• 1 other identifier: 2016-00909
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Contrast sensitivity

  Year 1

• Tilting sensitivity

  Year 1

• Decentration sensitivity

  Year 1

• Patient satisfaction

  Year 1

• Adverse events

  Year 1

Interventions

InFo - Instant Focus (c) lens implantation DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• 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
• Pregnant, breastfeeding, or unable to understand the character and individual consequences of the investigation

Sponsors & Collaborators

• SAV-IOL SA: lead
• CEISO: collaborator

MeSH Terms

Conditions

Cataract

Interventions

Lens Implantation, Intraocular

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• André Mermoud, Prof

  Clinique Montchoisi Lausanne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 22, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2019
• Last Updated: May 6, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share