Refractive ErrorNCT03789669
A Prospective, Multi-Center Evaluation of Corneal Flap Creation Using Cheetah Femtosecond Laser System and Cheetah Patient Interface
A study testing IntraLase iFS femtosecond laser and patient interface and Cheetah femtosecond laser and cheetah patient interface in people with Refractive Error, run by Johnson & Johnson Surgical Vision, Inc. at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Error
- What is being tested?
- IntraLase iFS femtosecond laser and patient interface and Cheetah femtosecond laser and cheetah patient interface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 19 Dec 2018to 31 Mar 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
India2 sites
Narayana Nethralaya Eye Hospital
RajajiNagar, Bangalore, 560010
Center For Sight
Safdarjung Enclave, New Delhi, 110029
About this study
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.
Read the 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.
- Conditions
- Refractive Error
- Being tested
- IntraLase iFS femtosecond laser and patient interface, Cheetah femtosecond laser and cheetah patient interface
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntraLase iFS femtosecond laser and patient interfaceDevice
Commercial ophthalmic laser surgical system
Cheetah femtosecond laser and cheetah patient interfaceDevice
Ophthalmic laser surgical system
| Study group | Role | What they receive |
|---|---|---|
| Investigational/Control | Active comparator | Both eyes of each subject will be treated. The investigators will use the investigational Cheetah femtosecond laser and Cheetah PI on one eye, and commercial iFS femtosecond laser and PI on the other eye 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 eye to receive Cheetah flap 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 will be used on both eyes). Receives: Device: IntraLase iFS femtosecond laser and patient interface |
| Control/Investigational | Active comparator | Both eyes of each subject will be treated. The investigators will use the commercial Cheetah femtosecond laser and Cheetah two piece PI on one eye, and commercial Cheetah femtosecond laser and investigational Cheetah 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 eye to receive Cheetah flap 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 will be used on both eyes). Receives: Device: Cheetah femtosecond laser and cheetah patient interface |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the Operative visit, one time visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start19 Dec 2018
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractive ErrorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Surgical Vision Clinical Trials, Study director, Johnson & Johnson Surgical Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789669
- Sponsor's protocol ID
- CHTA-103-FLAP
- Status last verified
- May 2025
- First submitted
- 27 Dec 2018
- Last updated
- 31 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No