Clinical Investigation of the Cheetah System For The Correction of Myopia With and Without Astigmatism

NCT04200898 | Completed FDA Device

• 1 other identifier: CHTA-104-ILEX
• Study Type: interventional
• Target: 286
• Locations: 4 countries
• Sites: 6

Brief 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.

Conditions

Myopia; Astigmatism

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months

Study Arms (3)

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.

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.

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.

Device: Cheetah System

Interventions

Cheetah System DEVICE

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).

Cheetah System: Phase 1; Cheetah System: Phase 2; Cheetah System: Phase 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Evidence of glaucoma regardless of medication regimen or control, an IOP greater than 21 mmHg at screening or propensity for narrow angle glaucoma.
• 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.
• 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.

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (6)

Svjetlost Eye Clinic

Zagreb, City of Zagreb, 10000, Croatia

Location

Narayana Nethralaya Eye Hospital

RajajiNagar, Bangalore, 560010, India

Location

Centre For Sight

New Delhi, National Capital Territory of Delhi, 110075, India

Location

Centro Oculistico Bresciano

Brescia, 25122, Italy

Location

Singapore Eye Research Institute

Singapore, 168753, Singapore

Location

Tan Tock Seng Hospital PTE. LTD.

Singapore, 308433, Singapore

Location

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Johnson & Johnson Surgical Vision Clinical Trials

  Johnson & Johnson Surgical Vision

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 16, 2019
• Study Start: December 31, 2019
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

IN (2); CR (1); IT (1); SG (2)