Refractive Error
Conditions
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.
Interventions
DEVICEIntraLase iFS femtosecond laser and patient interface
Commercial ophthalmic laser surgical system
DEVICECheetah femtosecond laser and cheetah patient interface
Ophthalmic laser surgical system
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stromal Bed Surface Quality | At the Operative visit, one time visit | Surface quality will be graded on a scale of 1-5 relative to Intralase iFS flap. Number of Participants with Stromal Bed Surface Quality scale of 3 or higher. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Flap Thickness | 3 months | The central flap thickness is measured per each eye, compared from ELITA vs. iFS performances. |
Countries
India, Singapore
Participant flow
Recruitment details
This is a paired-eye study design in which for each subject, one eye is treated with ELITA and the fellow eye is treated with iFS. For the primary endpoints, a relative scale of 1-5 was used to compare the performance of the ELITA treated eye vs iFS treated eye. The primary endpoint evaluations require both eyes to be treated; thus, 3 unilaterally treated subjects were excluded from the analysis. There is only one arm for primary endpoint evaluation; and two arms for other analyses.
Pre-assignment details
A total of 200 subjects were enrolled in the study. 45 subjects were consented but not treated in the study. 3 subjects were one-eye treated with ELITA; and 197 subjects were treated bilateral (one eye treated with ELITA, one eye treated with controlled system iFS). 3 unilaterally treated subjects were excluded from the analysis. A score of 4 or 5: study eye was better than the control eye. A score of 3: equal performance. A score of 1 or 2: study eye was worse than the control eye.
Participants by arm
| Arm | Count |
|---|---|
| Unilateral ELITA - One Eye Treated with ELITA, Fellow Eye Not Treated | 3 |
| Unilateral ELITA - One Eye Treated with ELITA, Fellow Eye Not Treated | 3 |
| Bilateral One eye treated with ELITA, fellow eye treated with iFS | 197 |
| Bilateral One eye treated with ELITA, fellow eye treated with iFS | 394 |
| Total | 597 |
Baseline characteristics
| Characteristic | Unilateral | Total | Bilateral |
|---|---|---|---|
| Age, Customized 30-39 years old | 1 Participants | 54 Participants | 53 Participants |
| Age, Customized <30 years old | 2 Participants | 143 Participants | 141 Participants |
| Age, Customized 40-49 years old | 0 Participants | 3 Participants | 3 Participants |
| Age, Customized >=50 years old | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 200 Participants | 197 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 200 Participants | 197 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 97 Participants | 95 Participants |
| Sex: Female, Male Male | 1 Participants | 103 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 197 |
| other Total, other adverse events | 3 / 3 | 2 / 197 |
| serious Total, serious adverse events | 0 / 3 | 0 / 197 |
Outcome results
Primary
Stromal Bed Surface Quality
Surface quality will be graded on a scale of 1-5 relative to Intralase iFS flap. Number of Participants with Stromal Bed Surface Quality scale of 3 or higher.
Time frame: At the Operative visit, one time visit
Population: 3 unilaterally treated subjects were excluded from the analysis. There is only one arm analyzed for primary outcome measure. The primary endpoint evaluations require both eyes to be treated.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Unilateral | Stromal Bed Surface Quality | 0 Eyes |
| Bilateral | Stromal Bed Surface Quality | 175 Eyes |
Other Pre-specified
Flap Thickness
The central flap thickness is measured per each eye, compared from ELITA vs. iFS performances.
Time frame: 3 months
Population: This Outcome Measure has different Group from the Outcome Measure 1, Test Group with one eye with ELITA and Control Group, the fellow eye with the iFS. At 3-month visit, there were only 132 participants in the analysis. These data were not collected from participants in the Unilateral group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unilateral | Flap Thickness | 109.32 microMeter | Standard Deviation 6.55 |
| Bilateral | Flap Thickness | 109.77 microMeter | Standard Deviation 6.53 |