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OpenTrials
Completed

NCT Number: NCT02841670

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

InFo - Instant Focus (c) lens implantation

Device

Primary outcomes

  1. Near best corrected visual acuity

    Time frame: Year 1

  2. Intermediate (80cm) best corrected visual acuity

    Time frame: Year 1

  3. Far best corrected visual acuity

    Time frame: Year 1

  4. Near uncorrected visual acuity

    Time frame: Year 1

  5. Intermediate (80cm) uncorrected visual acuity

    Time frame: Year 1

  6. Far uncorrected visual acuity

    Time frame: Year 1

Secondary outcomes

  1. Contrast sensitivity

    Time frame: Year 1

  2. Tilting sensitivity

    Time frame: Year 1

  3. Decentration sensitivity

    Time frame: Year 1

  4. Patient satisfaction

    Time frame: Year 1

    Questionnaire

  5. Adverse events

    Time frame: Year 1

    Including Posterior Capsule Opacification rates

Sponsors and collaborators

Lead sponsor

SAV-IOL SA

Industry

Collaborators

  • CEISO

Registry information

Acronym: INFOLO

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Jul 22, 2016
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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