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

Not Applicable

Completed

• Conditions: Refractive Error

• Registration Number: NCT03789669
• Lead Sponsor: Johnson & Johnson Surgical Vision, Inc.

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.

Study Timeline

• Study Start: 2018-12-19
• Study First Submitted: 2018-12-27
• Study First Submitted QC: 2018-12-27
• Study First Posted: 2018-12-28
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Results First Submitted: 2024-09-27
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-28
• Last Update Submitted: 2025-05-28
• Results First Posted: 2025-05-31
• Last Update Posted: 2025-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Narayana Nethralaya Eye Hospital; 🇮🇳 Rajajinagar, Bangalore, India

Center For Sight; 🇮🇳 Safdarjung Enclave, New Delhi, India

Tan Tock Seng Hospital PTE. LTD.; 🇸🇬 Singapore, Singapore