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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
286
For each subject, surgeons will create an iLEX refractive correction using the investigational Cheetah femtosecond laser (Models Cheetah Beta 2a, Cheetah Production Equivalent \[ELITA\]) and Cheetah patient interface (regular or small diameter designs).
Svjetlost Eye Clinic
Zagreb, City of Zagreb, Croatia
Narayana Nethralaya Eye Hospital
RajajiNagar, Bangalore, India
Centre For Sight
New Delhi, National Capital Territory of Delhi, India
Centro Oculistico Bresciano
Brescia, Italy
Monocular Uncorrected Visual Acuity
Phase II and Phase III effectiveness endpoint. The proportion of eyes with each acuity line of Uncorrected Visual Acuity will be summarized at 1 month postoperative visit.
Time frame: 1 month
maintenance of Best Spectacle Corrected Visual Acuity
Phase II and III primary safety endpoint.The proportion of eyes with Best Spectacle Visual Acuity acuity line changes from preoperative visit will be summarized.
Time frame: 12 months
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Singapore Eye Research Institute
Singapore, Singapore
Tan Tock Seng Hospital PTE. LTD.
Singapore, Singapore