Status:
COMPLETED
A Prospective, Multi-Center Evaluation of Corneal Flap Creation Using Cheetah Femtosecond Laser System and Cheetah Patient Interface
Lead Sponsor:
Johnson & Johnson Surgical Vision, Inc.
Conditions:
Refractive Error
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study is a prospective, open-label, comparative study design that was chosen for the purpose of optimizing the Cheetah settings, and evaluating the Cheetah system quality of LASIK flap.
Detailed Description
This study is a 3-month, prospective, multicenter, open-label, comparative, randomized (1:1 ratio for right and left eyes) study. The study will be conducted at up to 5 sites and up to 300 treated su...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- To be considered for enrollment 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 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
Exclusion
Key Trial Info
Start Date :
December 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03789669
Start Date
December 19 2018
End Date
March 31 2023
Last Update
May 31 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Narayana Nethralaya Eye Hospital
RajajiNagar, Bangalore, India, 560010
2
Center For Sight
Safdarjung Enclave, New Delhi, India, 110029
3
Tan Tock Seng Hospital PTE. LTD.
Singapore, Singapore, 308433