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| Name | Class |
|---|---|
| CEISO | INDUSTRY |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InFo - Instant Focus (c) lens implantation | Device |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Far uncorrected visual acuity | Year 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast sensitivity | Year 1 | |
| Tilting sensitivity | Year 1 | |
| Decentration sensitivity |
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Inclusion criteria:
Non inclusion criteria:
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Patients with cataract will be recruited from the clinic by the investigator based on the inclusion and exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| André Mermoud, Prof | Clinique Montchoisi Lausanne | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 15, 2019 | |
| Unrelease | May 21, 2019 | |
| Release | May 21, 2019 | |
| Reset | Jul 24, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 15, 2019 | May 21, 2019 | |||
| May 21, 2019 |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D019654 | Lens Implantation, Intraocular |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Year 1 |
| Patient satisfaction | Questionnaire | Year 1 |
| Adverse events | Including Posterior Capsule Opacification rates | Year 1 |
| Jul 24, 2019 |