MyopiaNCT04200898
Clinical Investigation of the Cheetah System For The Correction of Myopia With and Without Astigmatism
A study testing Cheetah System in people with Myopia and Astigmatism, run by Johnson & Johnson Surgical Vision, Inc. at 6 sites in 4 countries.
Trial summary
This study will be a 3-phase, 12-months, prospective,single arm, multicenter, open-label, non-comparative, clinical investigation conducted at up to 7 sites. Up to 20 subjects will be enrolled in phase I, up to 30 subjects in phase II, and up to 200 subjects in phase 3 to achieve up to 350 treated eyes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- Cheetah System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 31 Dec 2019to 6 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Note: All criteria apply to each Cheetah treated eye
- Age ≥18 years old at the time of consenting.
- Subjects with refractive error within the following ranges:
- Phase I: Partially sighted eyes (as defined below)
- Phase II: Refractive error range in the Cheetah-treated eye/s between -2.00 D to -6.00 D and astigmatism up to -1.00 D based on manifest refraction at optical infinity. If cyclotorsion correction after docking is available, astigmatism greater than -1. 00 D can be included, provided that spherical equivalent (SE) is up to -6.00 D.
- Phase III: Myopic refractive error in the study eye up to -12.00 D spherical equivalent (SE) and astigmatism up to - 6.00 D based on manifest refraction at optical infinity.
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- Anticipated residual corneal stromal thickness of at least 250 microns based on preoperative corneal pachymetry minus maximum lenticule thickness to be extracted.
- Uncorrected visual acuity of 20/40 or worse in Phase II and III subjects.
- Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better for phase II and III subjects. For phase I subjects, BSCVA and pin-hole acuity of the iLEX treated eye is worse than 20/50, with at least a 2-line difference between the iLEX treated eye and the fellow eye.
- Note: Potential phase I subjects to be evaluated on a case-by-case basis for interocular difference in visual acuity and enrollment to be confirmed through Medical Monitor and PI consensus.
- BSCVA ≥2 lines better than distance Uncorrected Visual Acuity (UCVA). Not applicable for phase I subjects.
- Less than or equal to 0.75 D difference between cycloplegic and manifest refraction sphere. Not applicable for phase I subjects.
- A stable refractive error (based on a previous exam, medical records, lensometry, or prescription at least 12 months prior to the preoperative manifest refraction), as defined by a change of ≤1.00 D in MRSE. Additionally, the astigmatic axis must also be within 15 degrees for eyes with >0.50 D of preoperative and historical manifest cylinder.
- Any subject eye with a history of contact lens wear within the last 4 weeks must demonstrate refractive stability according to the following:
- Rigid contact lenses (toric or spherical) must be removed for at least 4 weeks and soft contact lenses (toric or spherical) for at least 2 weeks prior to the first refraction used to establish stability.
- Two consecutive manifest refractions and keratometry readings must be conducted at least 7 days apart.
- Refractive stability is defined as a change of not more than 0.50 D in manifest refractive sphere and cylinder as well as keratometry meridian (either axis) between measurements. If the subject/eye meets the refractive stability criteria, contact lens wear is not permitted prior to surgery, as specified above for rigid and soft contact lens wearers.
- Willing and capable of complying with follow-up examinations for the duration of the study.
- Signed informed consent or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment.
Who cannot join
- Note: All criteria apply to each eye
- Concurrent use of systemic (including inhaled) medications that may impair healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment. NOTE: The use of inhaled or systemic corticosteroids, whether chronic or acute, is deemed to adversely affect healing and subjects using such medications are specifically excluded from eligibility. History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but not limited to unstable thyroid disorders), lupus, and rheumatoid arthritis.
- Subjects with history of Diabetes Mellitus of 12 years or more and HbA1c measurement greater than 7% within a month prior to treatment.
- Subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device.
- History of prior intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, symptomatic blepharitis, recurrent corneal erosion, history or evidence of corneal ulcer (including but not limited to presence of visible corneal scar, abnormal topography is NOT necessary), clinically significant dry eye syndrome, neovascularization > 1 mm from limbus), retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm and visible on topography. Note: For phase I subjects (partially sighted eyes), history of intraocular surgery (including cataract extraction), retinal detachment/repair, and clinically significant lens opacity is acceptable for inclusion in the study.
- Evidence of glaucoma regardless of medication regimen or control, an IOP greater than 21 mmHg at screening or propensity for narrow angle glaucoma.
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- NOTE: Phase I subjects with end-stage glaucoma and completely extinguished visual field are eligible to participate in the study.
- Evidence of keratoconus, pellucid marginal degeneration, corneal dystrophy or irregularity, unstable (distorted/not clear) corneal mires on central keratometry images, corneal edema, corneal lesion, hypotony, or abnormal topography. Corneal thickness less than 470 microns at the thinnest point
- Known sensitivity or inappropriate responsiveness to any of the medications used in the postoperative course.
- Either eye does not meet all inclusion criteria and does not fall within approved indications for treatment using femtosecond or excimer Laser. Not applicable for phase I subjects.
- Desire for monovision correction. Not applicable for phase I subjects.
- Women who are pregnant, breast-feeding, or intend to become pregnant during the study.
- Participation in any other clinical study.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
India2 sites
Centre For Sight
New Delhi, National Capital Territory of Delhi, 110075
Narayana Nethralaya Eye Hospital
RajajiNagar, Bangalore, 560010
Singapore2 sites
Singapore Eye Research Institute
Singapore, 168753
Tan Tock Seng Hospital PTE. LTD.
Singapore, 308433
About this study
Official title: Clinical Investigation of the Cheetah System For The Correction of Myopic Refractive Errors With and Without Astigmatism
This study will be a 3-phase, 12-months, prospective,single arm, multicenter, open-label, non-comparative, clinical investigation conducted at up to 7 sites. Up to 20 subjects will be enrolled in phase I, up to 30 subjects in phase II, and up to 200 subjects in phase 3 to achieve up to 350 treated eyes.
Read the detailed description
Phase I will be used to evaluate performance (safety, ease of lenticule removal, procedure workflow, and software settings). During phase I (limited to partially sighted eyes as defined in the inclusion section), one eye of each subject will undergo iLEX treatment and the fellow eye may undergo a commercial refractive correction at the discretion of the investigator, provided there is at least 1.00 D of sphere refractive error based on manifest refraction. During phase I, treatment will be up to -11.00 D sphere with no astigmatism correction.
Phase II will be used to evaluate initial safety and effectiveness. During phase II, no astigmatism correction will be performed unless cyclotorsion correction after docking is available. For the first 10 subjects in phase II, iLEX treatment will be performed on one eye (worse eye) and approximately 1 week later, if treatment is warranted, on the fellow eye. Prior to second eye treatment in the first 10 subjects, subjects will be asked if they have any eye disturbances and whether they are willing to have their second eye treated in the study. Following eligible second eye treatment of the first 10 consecutive phase II subjects with no operative concerns by the investigator and medical monitor, subsequent phase II subjects may undergo iLEX treatment in both eyes on the same day.
Phase III will be used to evaluate long term safety and effectiveness (i.e., 12 months). During phase III, subjects may undergo iLEX treatment in both eyes on the same day.
- Conditions
- Myopia, Astigmatism
- Being tested
- Cheetah System
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cheetah SystemDevice
For each subject, surgeons will create an iLEX refractive correction using the investigational Cheetah femtosecond laser (Models Cheetah Beta 2a, Cheetah Production Equivalent [ELITA]) and Cheetah patient interface (regular or small diameter designs).
| Study group | Role | What they receive |
|---|---|---|
| Cheetah System: Phase 1 | Experimental | For each subject, surgeons will create an iLEX refractive correction using the investigational Cheetah femtosecond laser (either Beta 2a or Cheetah Production Equivalent [ELITA] models) and Cheetah patient interface (regular or small diameter designs) on one eye and the fellow eye may undergo a commercial refractive correction at the discretion of the investigator. Receives: Device: Cheetah System |
| Cheetah System: Phase 2 | Experimental | For each subject, surgeons will create an iLEX refractive correction using the investigational Cheetah femtosecond laser (either Beta 2a or ELITA models) and Cheetah patient interface (regular or small diameter designs) on one/both eyes (worse eye first followed by second eye, approximately 1 week later) based on refractive correction needs. Receives: Device: Cheetah System |
| Cheetah System: Phase 3 | Experimental | For each subject, surgeons will create an iLEX refractive correction using the investigational Cheetah femtosecond laser (either Beta 2a or ELITA models) and Cheetah patient interface (regular or small diameter designs) on one/both eyes (on the same day) based on refractive correction needs. Receives: Device: Cheetah System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular Uncorrected Visual Acuity
Phase II and Phase III effectiveness endpoint. The proportion of eyes with each acuity line of Uncorrected Visual Acuity will be summarized at 1 month postoperative visit.
Measured: 1 month
maintenance of Best Spectacle Corrected Visual Acuity
Phase II and III primary safety endpoint.The proportion of eyes with Best Spectacle Visual Acuity acuity line changes from preoperative visit will be summarized.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start31 Dec 2019
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 286 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
- NCT04200898
- Sponsor's protocol ID
- CHTA-104-ILEX
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2019
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Johnson \& Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Cheetah System For The Correction of Myopic Refractive Errors With and Without Astigmatism
- ClinicalTrials.gov ID
- NCT04200898
- Acronym / sponsor ID
- CHTA-104-ILEX
- Conditions
- Myopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2019 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a 3-phase, 12-months, prospective,single arm, multicenter, open-label, non-comparative, clinical investigation conducted at up to 7 sites. Up to 20 subjects will be enrolled in phase I, up to 30 subjects in phase II, and up to 200 subjects in phase 3 to achieve up to 350 treated eyes.
Detailed description
Phase I will be used to evaluate performance (safety, ease of lenticule removal, procedure workflow, and software settings). During phase I (limited to partially sighted eyes as defined in the inclusion section), one eye of each subject will undergo iLEX treatment and the fellow eye may undergo a commercial refractive correction at the discretion of the investigator, provided there is at least 1.00 D of sphere refractive error based on manifest refraction. During phase I, treatment will be up to -11.00 D sphere with no astigmatism correction.
Phase II will be used to evaluate initial safety and effectiveness. During phase II, no astigmatism correction will be performed unless cyclotorsion correction after docking is available. For the first 10 subjects in phase II, iLEX treatment will be performed on one eye (worse eye) and approximately 1 week later, if treatment is warranted, on the fellow eye. Prior to second eye treatment in the first 10 subjects, subjects will be asked if they have any eye disturbances and whether they are willing to have their second eye treated in the study. Following eligible second eye treatment of the first 10 consecutive phase II subjects with no operative concerns by the investigator and medical monitor, subsequent phase II subjects may undergo iLEX treatment in both eyes on the same day.
Phase III will be used to evaluate long term safety and effectiveness (i.e., 12 months). During phase III, subjects may undergo iLEX treatment in both eyes on the same day.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cheetah System: Phase 1 | Experimental | Device: Cheetah SystemFor each subject, surgeons will create an iLEX refractive correction using the investigational Cheetah femtosecond laser (either Beta 2a or Cheetah Production Equivalent [ELITA] models) and Cheetah patient interface (regular or small diameter designs) on one eye and the fellow eye may undergo a commercial refractive correction at the discretion of the investigator. |
| Cheetah System: Phase 2 | Experimental | Device: Cheetah SystemFor each subject, surgeons will create an iLEX refractive correction using the investigational Cheetah femtosecond laser (either Beta 2a or ELITA models) and Cheetah patient interface (regular or small diameter designs) on one/both eyes (worse eye first followed by second eye, approximately 1 week later) based on refractive correction needs. |
| Cheetah System: Phase 3 | Experimental | Device: Cheetah SystemFor each subject, surgeons will create an iLEX refractive correction using the investigational Cheetah femtosecond laser (either Beta 2a or ELITA models) and Cheetah patient interface (regular or small diameter designs) on one/both eyes (on the same day) based on refractive correction needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Note: All criteria apply to each Cheetah treated eye
- Age ≥18 years old at the time of consenting.
- Subjects with refractive error within the following ranges:
- Anticipated residual corneal stromal thickness of at least 250 microns based on preoperative corneal pachymetry minus maximum lenticule thickness to be extracted.
- Uncorrected visual acuity of 20/40 or worse in Phase II and III subjects.
Key exclusion criteria (13 listed)
- Note: All criteria apply to each eye
- Concurrent use of systemic (including inhaled) medications that may impair healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment. NOTE: The use of inhaled or systemic corticosteroids, whether chronic or acute, is deemed to adversely affect healing and subjects using such medications are specifically excluded from eligibility. History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but not limited to unstable thyroid disorders), lupus, and rheumatoid arthritis.
- Subjects with history of Diabetes Mellitus of 12 years or more and HbA1c measurement greater than 7% within a month prior to treatment.
- Subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device.
- History of prior intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, symptomatic blepharitis, recurrent corneal erosion, history or evidence of corneal ulcer (including but not limited to presence of visible corneal scar, abnormal topography is NOT necessary), clinically significant dry eye syndrome, neovascularization > 1 mm from limbus), retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm and visible on topography. Note: For phase I subjects (partially sighted eyes), history of intraocular surgery (including cataract extraction), retinal detachment/repair, and clinically significant lens opacity is acceptable for inclusion in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cheetah SystemFor each subject, surgeons will create an iLEX refractive correction using the investigational Cheetah femtosecond laser (Models Cheetah Beta 2a, Cheetah Production Equivalent [ELITA]) and Cheetah patient interface (regular or small diameter designs). | Device | Cheetah System: Phase 1, Cheetah System: Phase 2, Cheetah System: Phase 3 |
Primary outcome
Monocular Uncorrected Visual Acuity
Time frame: 1 month
Phase II and Phase III effectiveness endpoint. The proportion of eyes with each acuity line of Uncorrected Visual Acuity will be summarized at 1 month postoperative visit.
maintenance of Best Spectacle Corrected Visual Acuity
Time frame: 12 months
Phase II and III primary safety endpoint.The proportion of eyes with Best Spectacle Visual Acuity acuity line changes from preoperative visit will be summarized.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Surgical Vision Clinical Trials study director
Johnson & Johnson Surgical Vision
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cheetah System in people with Myopia and Astigmatism, run by Johnson & Johnson Surgical Vision, Inc. at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India, Singapore, Croatia, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocular Uncorrected Visual Acuity (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.