Evaluation of a new laser system for creating LASIK eye flaps
A Prospective, Multi-Center Evaluation of Corneal Flap Creation Using Cheetah Femtosecond Laser System and Cheetah Patient Interface
This study is testing a new laser system for making LASIK eye flaps to see if it can improve the quality of the surgery for people needing vision correction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johnson & Johnson Surgical Vision, Inc. Industry-sponsored |
| Locations | 3 sites (Rajajinagar, Bangalore and 2 other locations) |
| Trial ID | NCT03789669 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, multi-center evaluation of the Cheetah femtosecond laser system for creating LASIK eye flaps. The study consists of two phases: the first phase focuses on optimizing the laser settings, while the second phase evaluates the quality of the LASIK flaps created using these optimized settings. Up to 300 subjects will be enrolled across multiple sites, with one eye treated in phase I and both eyes potentially treated in phase II. The study aims to assess flap lift, thickness, and diameter to ensure optimal outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with best corrected vision of 20/50 or worse who are available for follow-up visits.
Not a fit: Patients with recent eye trauma, a history of eye diseases, or conditions affecting wound healing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality and safety of LASIK procedures for patients with refractive errors.
How similar studies have performed: Other studies have shown success with similar laser systems, indicating potential for positive outcomes with this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rajajinagar, Bangalore and 2 other locations
- Narayana Nethralaya Eye Hospital — Rajajinagar, Bangalore, India (Active_not_recruiting)
- Center For Sight — Safdarjung Enclave, New Delhi, India (Recruiting)
- Tan Tock Seng Hospital PTE. LTD. — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: cjones56@its.jnj.com
- Phone: 1-669-252-5145
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.