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

Refractive Error Clinical Trial

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

Status Recruiting

Clinical Trial Summary

The study is a 2-phase, prospective, open-label, comparative (phase II) study design that was chosen for the purpose of optimizing the Cheetah settings (phase I), and evaluating the Cheetah system quality of LASIK flap (phase II).

Clinical Trial Description

This study is a 3-month, 2-phase, prospective, multicenter, open-label, comparative (phase II), randomized (phase II, 1:1 ratio for right and left eyes) study.

The study will be conducted at up to 5 sites and will include up to 30 treated subjects in phase I and up to 300 treated subjects in phase II to achieve minimum 40 eyes with optimized settings and additional eye data for further device experience.

Subjects will be enrolled in phase I until Cheetah setting optimization is achieved. After setting optimization, and upon medical monitor and principal investigator consensus, phase II of the study may begin.

For phase I, one eye of each subject will be included (worst seeing eye should be preferred). The investigational Cheetah femtosecond laser and Cheetah patient interface (PI) will be used on one eye to create a LASIK flap. Refractive correction via corneal ablation with a commercial excimer laser will be performed at the investigator's discretion, provided there is at least 1.00 D SE of refractive error. If refractive correction is performed on the study eye, the fellow eye may receive standard LASIK treatment, otherwise, fellow eye will remain untreated.

Once five consecutive phase I subjects show good flap lift, per investigator's evaluation, central flap thickness within ±10 µm of planned thickness, flap diameter within ±0.5 mm of planned diameter, and upon medical monitor and principal investigator consensus, phase II may begin.

In phase II both eyes of each subject will be treated. The investigator will use the Cheetah femtosecond laser, with the following possible procedures performed:

1. A comparison between the one and two piece PI with the Cheetah system in both eyes. The eye treated with the one piece PI will be the study eye and the eye treated with the two piece PI will be the control eye.

2. A comparison of commercial iFS femtosecond laser and PI in one eye and the Cheetah femtosecond laser (with the one or 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 in phase II 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. ;

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

• NCT number: NCT03789669
• Study type: Interventional
• Source: Johnson & Johnson Surgical Vision, Inc.
• Contact: Study Contact
• Phone: 1-669-252-5145
• Email: cjones56@its.jnj.com
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2018
• Completion date: August 31, 2024