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

NCT03789669

CompletedNA

Sponsor: Johnson & Johnson Surgical Vision, Inc.

Conditions: Refractive Error

Interventions: IntraLase iFS femtosecond laser and patient interface, Cheetah femtosecond laser and cheetah patient interface

Countries: India, Singapore

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (3)

RajajiNagar, Bangalore, India
Safdarjung Enclave, New Delhi, India
Singapore, Singapore