CataractINFOLONCT02841670
Evaluation of Efficacy and Long-term Safety for the InFo - Instant Focus © Lens / PMCF
An observational study of Cataract, run by SAV-IOL SA.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- InFo - Instant Focus (c) lens implantation
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cataract will be recruited from the clinic by the investigator based on the inclusion and exclusion criteria
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
About this study
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.
Read more
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
- Being tested
- InFo - Instant Focus (c) lens implantation
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InFo - Instant Focus (c) lens implantationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Near best corrected visual acuity
Measured: Year 1
Intermediate (80cm) best corrected visual acuity
Measured: Year 1
Far best corrected visual acuity
Measured: Year 1
Near uncorrected visual acuity
Measured: Year 1
Intermediate (80cm) uncorrected visual acuity
Measured: Year 1
Far uncorrected visual acuity
Measured: Year 1
Secondary outcomes (5)
Contrast sensitivity
Measured: Year 1
Tilting sensitivity
Measured: Year 1
Decentration sensitivity
Measured: Year 1
Patient satisfaction
Questionnaire
Measured: Year 1
Adverse events
Including Posterior Capsule Opacification rates
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2017
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- SAV-IOL SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEISO
- Responsible party
- Sponsor
- Investigators
- André Mermoud, Prof, Principal investigator, Clinique Montchoisi Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841670
- Sponsor's protocol ID
- 2016-00909
- Other IDs
- 2016
- Acronym
- INFOLO
- Status last verified
- May 2019
- First submitted
- 12 Jul 2016
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Long-term Safety for the InFo - Instant Focus © Lens / PMCF
- ClinicalTrials.gov ID
- NCT02841670
- Acronym / sponsor ID
- INFOLO / 2016-00909
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SAV-IOL SAIndustry (pharma, biotech, devices)
- Collaborators
- CEISO
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cataract will be recruited from the clinic by the investigator based on the inclusion and exclusion criteria
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InFo - Instant Focus (c) lens implantation | Device | – |
Primary outcome
Near best corrected visual acuity
Time frame: Year 1
Intermediate (80cm) best corrected visual acuity
Time frame: Year 1
Far best corrected visual acuity
Time frame: Year 1
Near uncorrected visual acuity
Time frame: Year 1
Intermediate (80cm) uncorrected visual acuity
Time frame: Year 1
Far uncorrected visual acuity
Time frame: Year 1
5 secondary outcomes
Contrast sensitivity
Time frame: Year 1
Tilting sensitivity
Time frame: Year 1
Decentration sensitivity
Time frame: Year 1
Patient satisfaction
Time frame: Year 1
Adverse events
Time frame: Year 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André Mermoud, Prof principal investigator
Clinique Montchoisi Lausanne
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by SAV-IOL SA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Near best corrected visual acuity (time frame: Year 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.