ClinicalTrials.Veeva

Menu

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

S

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems