A Prospective, Multi-Center Evaluation of Corneal Flap Creation Using Cheetah Femtosecond Laser System and Cheetah Patient Interface
Refractive Error
About this trial
This is an interventional treatment trial for Refractive Error
Eligibility Criteria
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
Sites / Locations
- Narayana Nethralaya Eye HospitalRecruiting
- Center For SightRecruiting
- Tan Tock Seng Hospital PTE. LTD.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Investigational
Investigational/Control
Control/Investigational
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.
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).
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).