Clinical Investigation of the CHEETAH SYSTEM FOR THE CORRECTION OF MYOPIC REFRACTIVE ERRORS WITH AND WITHOUT ASTIGMATISM
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- STATUS
- Recruiting
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- End date
- Dec 30, 2023
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- participants needed
- 250
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- sponsor
- Johnson & Johnson Surgical Vision, Inc.
Summary
This study will be a 3-phase, 12-months, prospective,single arm, multicenter, open-label, non-comparative, clinical investigation conducted at up to 7 sites. Up to 20 subjects will be enrolled in phase I, up to 30 subjects in phase II, and up to 200 subjects in phase 3 to achieve up to 350 treated eyes.
Description
Phase I will be used to evaluate performance (safety, ease of lenticule removal, procedure workflow, and software settings). During phase I (limited to partially sighted eyes as defined in the inclusion section), one eye of each subject will undergo iLEX treatment and the fellow eye may undergo a commercial refractive correction at the discretion of the investigator, provided there is at least 1.00 D of sphere refractive error based on manifest refraction. During phase I, treatment will be up to -11.00 D sphere with no astigmatism correction.
Phase II will be used to evaluate initial safety and effectiveness. During phase II, no astigmatism correction will be performed unless cyclotorsion correction after docking is available. For the first 10 subjects in phase II, iLEX treatment will be performed on one eye (worse eye) and approximately 1 week later, if treatment is warranted, on the fellow eye. Prior to second eye treatment in the first 10 subjects, subjects will be asked if they have any eye disturbances and whether they are willing to have their second eye treated in the study. Following eligible second eye treatment of the first 10 consecutive phase II subjects with no operative concerns by the investigator and medical monitor, subsequent phase II subjects may undergo iLEX treatment in both eyes on the same day.
Phase III will be used to evaluate long term safety and effectiveness (i.e., 12 months). During phase III, subjects may undergo iLEX treatment in both eyes on the same day.
Details
| Condition | Myopia, Astigmatism |
|---|---|
| Treatment | Cheetah System |
| Clinical Study Identifier | NCT04200898 |
| Sponsor | Johnson & Johnson Surgical Vision, Inc. |
| Last Modified on | 27 October 2022 |
Eligibility
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