Cataract
Conditions
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.
Interventions
DEVICEInFo - Instant Focus (c) lens implantation
Sponsors
CEISO
SAV-IOL SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Far uncorrected visual acuity | Year 1 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tilting sensitivity | Year 1 | — |
| Decentration sensitivity | Year 1 | — |
| Patient satisfaction | Year 1 | Questionnaire |
| Adverse events | Year 1 | Including Posterior Capsule Opacification rates |
| Contrast sensitivity | Year 1 | — |
Outcome results
None listed