Clinical trial NCT03789669: A Prospective, Multi-Center Evaluation of Corneal Flap Creation Using Cheetah Femtosecond Laser System and Cheetah Patient Interface
Official title: A Prospective, Multi-Center Evaluation of Corneal Flap Creation Using Cheetah Femtosecond Laser System and Cheetah Patient Interface
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 subjects to achieve minimum 40 eyes with optimized settings and additional eye data for further device experience.

Both eyes of each subject will be treated. The investigator will use the Cheetah femtosecond laser, with the following possible procedures performed:

A comparison of commercial iFS femtosecond laser and PI in one eye and the Cheetah femtosecond laser (with the 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 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.

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

Primary outcomes:
measure: Stromal Bed Surface Quality
timeFrame: At the Operative visit, one time visit
Secondary outcomes:
Other outcomes:
measure: Flap Thickness
timeFrame: 3 months
Locations:
city: Rajajinagar
country: India
facility: Narayana Nethralaya Eye Hospital
state: Bangalore
city: Safdarjung Enclave
country: India
facility: Center For Sight
state: New Delhi
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital PTE. LTD.
Study officials:
affiliation: Johnson & Johnson Surgical Vision
name: Johnson & Johnson Surgical Vision Clinical Trials
role: STUDY_DIRECTOR
References: