Evaluation of Efficacy and Long-term Safety for the InFo - Instant Focus © Lens / PMCF
NCT ID: NCT02841670
Last Updated: 2019-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
30 participants
OBSERVATIONAL
2016-08-31
2019-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Efficacy and Long-term Safety for Lucidis Instant Focus© - PMCF Study Protocol
NCT04761276
PMCF Study of Preloaded Trifocal IOL
NCT04884178
Visual Outcomes of Functional Intraocular Lenses in Cataracts
NCT06092164
Comparative Study of Two Multifocal Intraocular Lens With Different Add Power
NCT02424162
PMCF Study on Comparison of EDOF Lenses (Switzerland)
NCT05235139
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
InFo - Instant Focus (c) lens implantation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Participation in other interventional therapeutic trial at time of inclusion
* Pregnant, breastfeeding, or unable to understand the character and individual consequences of the investigation
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CEISO
INDUSTRY
SAV-IOL SA
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
André Mermoud, Prof
Role: PRINCIPAL_INVESTIGATOR
Clinique Montchoisi Lausanne
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-00909
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.