A Prospective, Multi-Center Evaluation of Corneal Flap Creation Using Cheetah Femtosecond Laser System and Cheetah Patient Interface

NCT03789669 | Completed Results FDA Device

• 1 other identifier: CHTA-103-FLAP
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 3

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.

Conditions

Refractive Error

Outcome Measures

Primary Outcomes (1)

• 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.

  At the Operative visit, one time visit

Other Outcomes (1)

• Flap Thickness

  3 months

Study Arms (2)

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).

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).

Device: Cheetah femtosecond laser and cheetah patient interface

Interventions

IntraLase iFS femtosecond laser and patient interface DEVICE

Commercial ophthalmic laser surgical system

Investigational/Control

Cheetah femtosecond laser and cheetah patient interface DEVICE

Ophthalmic laser surgical system

Control/Investigational

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (3)

Narayana Nethralaya Eye Hospital

RajajiNagar, Bangalore, 560010, India

Location

Center For Sight

Safdarjung Enclave, New Delhi, 110029, India

Location

Tan Tock Seng Hospital PTE. LTD.

Singapore, 308433, Singapore

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Brian Pall, Dr.
• Organization: Johnson & Johnson Surgical Vision

bpall@its.jnj.com

+1 904 6292289

Study Officials

• Johnson & Johnson Surgical Vision Clinical Trials

  Johnson & Johnson Surgical Vision

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: December 28, 2018
• Study Start: December 19, 2018
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 31, 2025
• Results First Posted: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2); SG (1)