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This study is a Pre-market first-in-man clinical investigation to validate performance of a hand-held femtosecond laser named CATSYS.
Interventional, prospective, longitudinal (follow-up: 30 ± 10 days), single-arm, single center, open trial. The "first-in-man" character of this investigation relies on the ergonomics of CATSYS (handpiece), and not on the laser technique, which is similar to other FLACS.
The purpose of the clinical investigation is to document the compliance of the investigational medical device with the general requirements of performance, safety and clinical benefit, in order to complete existing data and obtaining CE-mark for CATSYS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hand-held femtosecond laser | Experimental | Anterior capsulorhexis will be performed with a hand-held femtosecond laser named CATSYS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cataract surgery with CATSYS | Device | patient diagnosed with cataract requiring surgery will have an anterior capsulorhexis with CATSYS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Continuity of the capsulorhexis (success / failure) | Success achieved if:
| During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse device effects | Collection of adverse device effects by the investigator on the retina, on the cornea, on the posterior capsula and other adverse device events | 3 to 5 days after surgery |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Opthalmologique Sourdille Atlantique | Saint-Herblain | 44800 | France |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Collection by the investigator of other adverse events
| 3 to 5 days post-surgery; |
| Ocular adverse events | Collection by the investigator of ocular adverse events | 30 ± 10 days post-surgery. |