A Prospective, Multi-Center Evaluation of Corneal Flap Creation Using Cheetah Femtosecond Laser System and Cheetah Patient Interface

Study Overview
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Brief Summary
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The study is a 2-phase, prospective, open-label, comparative (phase II) study design that was chosen for the purpose of optimizing the Cheetah settings (phase I), and evaluating the Cheetah system quality of LASIK flap (phase II).

Detailed Description
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This study is a 3-month, 2-phase, prospective, multicenter, open-label, comparative (phase II), randomized (phase II, 1:1 ratio for right and left eyes) study. The study will be conducted at up to 5 sites and will include up to 30 treated subjects in phase I and up to 300 treated subjects in phase II to achieve minimum 40 eyes with optimized settings and additional eye data for further device experience. Subjects will be enrolled in phase I until Cheetah setting optimization is achieved. After setting optimization, and upon medical monitor and principal investigator consensus, phase II of the study may begin. For phase I, one eye of each subject will be included (worst seeing eye should be preferred). The investigational Cheetah femtosecond laser and Cheetah patient interface (PI) will be used on one eye to create a LASIK flap. Refractive correction via corneal ablation with a commercial excimer laser will be performed at the investigator's discretion, provided there is at least 1.00 D SE of refractive error. If refractive correction is performed on the study eye, the fellow eye may receive standard LASIK treatment, otherwise, fellow eye will remain untreated. Once five consecutive phase I subjects show good flap lift, per investigator's evaluation, central flap thickness within ±10 µm of planned thickness, flap diameter within ±0.5 mm of planned diameter, and upon medical monitor and principal investigator consensus, phase II may begin. In phase II both eyes of each subject will be treated. The investigator will use the Cheetah femtosecond laser, with the following possible procedures performed: A comparison between the one and two piece PI with the Cheetah system in both eyes. The eye treated with the one piece PI will be the study eye and the eye treated with the two piece PI will be the control eye. A comparison of commercial iFS femtosecond laser and PI in one eye and the Cheetah femtosecond laser (with the one or two piece PI) on the other eye. The eye treated with the Cheetah femtosecond laser will be the study eye and the eye treated with the commercial iFS femtosecond laser will be the control eye. All procedures will be performed to create a LASIK flap on subjects' corneas. Flap parameters (such as flap depth, flap diameter, and hinge angle) should be the same for both eyes. The study eye will be randomized (ratio of 1:1 for right eye and left eye). Subjects in phase II will undergo refractive correction via corneal ablation on both eyes using a commercial excimer laser for vision correction (same excimer laser system shall be used on both eyes). Over the course of the study, minor prototype device settings/improvements (with no safety implications and without compromising the clinical validity of the study) may be performed to optimize the quality of flap.

Official Title
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A Prospective, Multi-Center Evaluation of Corneal Flap Creation Using Cheetah Femtosecond Laser System and Cheetah Patient Interface

Conditions
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Refractive Error

Intervention / Treatment
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* Device: Cheetah femtosecond laser and Cheetah patient interface
* Device: IntraLase iFS iFS femtosecond laser and patient interface
* Device: Cheetah femtosecond laser and cheetah patient interface


Participation Criteria
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Eligibility Criteria
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Phase I of study INCLUSION CRITERIA To be considered for enrollment in phase I of the study, subject must: Sign an informed consent and HIPAA authorization Be at least 18 years of age at the time of study exam Have best corrected vision of 20/50 or worse Be available for all scheduled follow-up visits (see below) EXCLUSION CRITERIA Subject will not be eligible to take part in phase I of the study if subject, use or have: Known to be pregnant, breastfeeding or intend to become pregnant during the study. Recent ocular (eye) trauma or eye surgery A history of or active ophthalmic (eye) disease or abnormality Ocular hypertension (high eye pressure) with IOP (eye pressure) greater than 21 mmHg, glaucoma suspect, or are taking medications for these conditions A history or current diagnosis of any of the following medical conditions that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency disease, ocular herpes; endocrine disorders including, but not limited to unstable thyroid disorders and diabetes, lupus, and rheumatoid arthritis. Cardiac pacemaker, implanted defibrillator or other implanted electronic device Taking systemic or inhaled medications that may affect wound healing Known sensitivity or inappropriate responsiveness to any of the medications used in the study Participating in any other clinical study Phase II of study INCLUSION CRITERIA To be considered for enrollment in phase II of the study, subject must: Sign an informed consent and HIPAA authorization Be at least 18 years of age at the time of study exam Have refractive error and be eligible for commercial LASIK treatment Be available for all scheduled follow-up visits (see below) EXCLUSION CRITERIA Subject will not be eligible to take part in phase II of the study if subject, use or have: Known to be pregnant, breastfeeding or intend to become pregnant during the study. Recent ocular (eye) trauma or eye surgery A history of or active ophthalmic (eye) disease or abnormality Ocular hypertension (high eye pressure) with IOP (eye pressure) greater than 21 mmHg, glaucoma suspect, or are taking medications for these conditions A history or current diagnosis of any of the following medical conditions that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency disease, ocular herpes; endocrine disorders including, but not limited to unstable thyroid disorders and diabetes, lupus, and rheumatoid arthritis. Cardiac pacemaker, implanted defibrillator or other implanted electronic device Taking systemic or inhaled medications that may affect wound healing Known sensitivity or inappropriate responsiveness to any of the medications used in the study Desire for monovision correction Participating in any other clinical study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational<br>In phase I the investigators will use the investigational Cheetah femtosecond laser and Cheetah patient interface (PI) on one eye to create a LASIK flap (worst seeing eye should be preferred). Refractive correction via corneal ablation with a commercial excimer laser will be performed at the discretion of the investigator.If refractive correction is performed on the study eye, the fellow eye may receive standard LASIK treatment, otherwise, fellow eye will remain untreated. | Device: Cheetah femtosecond laser and Cheetah patient interface<br>* Ophthalmic laser surgical system<br>|
| Active Comparator: Investigational/Control<br>In phase II, both eyes of each subject will be treated. The investigators will use the investigational Cheetah femtosecond laser and Cheetah PI on one eye, and commercial iFS femtosecond laser and PI on the other eye to create a LASIK flap on subjects' corneas. Flap parameters (such as flap depth, flap diameter, and hinge angle) should be the same for both eyes. The eye to receive Cheetah flap will be randomized (ratio of 1:1 for right eye and left eye). Subjects in phase II will undergo refractive correction via corneal ablation on both eyes using a commercial excimer laser for vision correction (same excimer laser system will be used on both eyes). | Device: IntraLase iFS iFS femtosecond laser and patient interface<br>* Commercial ophthalmic laser surgical system<br>|
| Active Comparator: Control/Investigational<br>In phase II, both eyes of each subject will be treated. The investigators will use the commercial Cheetah femtosecond laser and Cheetah two piece PI on one eye, and commercial Cheetah femtosecond laser and investigational Cheetah one piece PI on the other eye to create a LASIK flap on subjects' corneas. Flap parameters (such as flap depth, flap diameter, and hinge angle) should be the same for both eyes. The eye to receive Cheetah flap will be randomized (ratio of 1:1 for right eye and left eye). Subjects in phase II will undergo refractive correction via corneal ablation on both eyes using a commercial excimer laser for vision correction (same excimer laser system will be used on both eyes). | Device: Cheetah femtosecond laser and cheetah patient interface<br>* Ophthalmic laser surgical system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cheetah ease of flap lift | Ease of flap lift will be graded on a scale of 1-5 relative to Intralase iFS flap. | Operative day | 
| surface quality | Surface quality will be graded on a scale of 1-5 relative to Intralase iFS flap. | Operative Day | 
| amount of opaque bubble layer (OBL) | Amount of opaque bubble layer will be graded on a scale of 1-5 relative to Intralase iFS flap. | Operative Day |