NCT03789669

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

Completed NA Results posted Last updated 31 May 2025

What this trial tests

NA trial testing IntraLase iFS femtosecond laser and patient interface in Refractive Error in 200 participants. Completed in 31 March 2023.

Timeline

19 December 2018

Primary endpoint
31 March 2023

31 March 2023

Quick facts

Lead sponsor	Johnson & Johnson Surgical Vision, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	19 December 2018
Primary completion	31 March 2023
Estimated completion	31 March 2023
Sites	3 locations across Singapore, India

Drugs / interventions tested

• IntraLase iFS femtosecond laser and patient interface
• Cheetah femtosecond laser and cheetah patient interface

Conditions studied

• Refractive Error — all drugs for Refractive Error →

Sponsor

Johnson & Johnson Surgical Vision, Inc. — full company profile →

Who can join

18 and older, any sex, with Refractive Error. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Stromal Bed Surface Quality Primary · 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.

Group	Value	95% CI
Unilateral	0
Bilateral	175

Flap Thickness Secondary · 3 months

The central flap thickness is measured per each eye, compared from ELITA vs. iFS performances.

Group	Value	95% CI
Test	109.32	± 6.55
Control	109.77	± 6.53

Adverse events — posted to ClinicalTrials.gov

Time frame: During the course of the study until termination (3 months). Reporting threshold: 0.15%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Unilateral

Serious: 0/3 (0%)

Deaths: 0/3

Bilateral

Serious: 0/197 (0%)

Deaths: 0/197

Other adverse events (3 terms — click to expand)

Reaction	System	Unilateral	Bilateral
Other	Surgical and medical procedures	—	—
Miscreated Flap	Surgical and medical procedures	—	—
Epithelium in the interface with a loss of 2 or more lines of BSCVA (>10 ETDRS letters)	Surgical and medical procedures	—	—

Data from ClinicalTrials.gov NCT03789669 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.