Trial Outcomes & Findings for A Prospective, Multi-Center Evaluation of Corneal Flap Creation Using Cheetah Femtosecond Laser System and Cheetah Patient Interface (NCT NCT03789669)

Last Updated: 2025-05-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

200 participants

Primary outcome timeframe

At the Operative visit, one time visit

Results posted on

2025-05-31

Participant Flow

This is a paired-eye study design in which for each subject, one eye is treated with ELITA and the fellow eye is treated with iFS. For the primary endpoints, a relative scale of 1-5 was used to compare the performance of the ELITA treated eye vs iFS treated eye. The primary endpoint evaluations require both eyes to be treated; thus, 3 unilaterally treated subjects were excluded from the analysis. There is only one arm for primary endpoint evaluation; and two arms for other analyses.

A total of 200 subjects were enrolled in the study. 45 subjects were consented but not treated in the study. 3 subjects were one-eye treated with ELITA; and 197 subjects were treated bilateral (one eye treated with ELITA, one eye treated with controlled system iFS). 3 unilaterally treated subjects were excluded from the analysis. A score of 4 or 5: study eye was better than the control eye. A score of 3: equal performance. A score of 1 or 2: study eye was worse than the control eye.

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Unilateral ELITA - One Eye Treated with ELITA, Fellow Eye Not Treated	Bilateral One eye treated with ELITA, fellow eye treated with iFS
Overall Study STARTED	3 3	197 394
Overall Study COMPLETED	0 0	197 394
Overall Study NOT COMPLETED	3 3	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Unilateral n=3 Eyes ELITA - One Eye Treated with ELITA, Fellow Eye Not Treated	Bilateral n=394 Eyes One eye treated with ELITA, fellow eye treated with iFS	Total n=397 Eyes Total of all reporting groups
Age, Customized >=50 years old	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 40-49 years old	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Age, Customized 30-39 years old	1 Participants n=5 Participants	53 Participants n=7 Participants	54 Participants n=5 Participants
Age, Customized <30 years old	2 Participants n=5 Participants	141 Participants n=7 Participants	143 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	95 Participants n=7 Participants	97 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	102 Participants n=7 Participants	103 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	197 Participants n=7 Participants	200 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	197 Participants n=7 Participants	200 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At the Operative visit, one time visit

Population: 3 unilaterally treated subjects were excluded from the analysis. There is only one arm analyzed for primary outcome measure. The primary endpoint evaluations require both eyes to be treated.

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.

Outcome measures

Outcome measures
Measure	Unilateral ELITA - One Eye Treated with ELITA, Fellow Eye Not Treated	Bilateral n=394 Eyes One eye treated with ELITA, fellow eye treated with iFS
Stromal Bed Surface Quality	0 Eyes	175 Eyes

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: This Outcome Measure has different Group from the Outcome Measure 1, Test Group with one eye with ELITA and Control Group, the fellow eye with the iFS. At 3-month visit, there were only 132 participants in the analysis. These data were not collected from participants in the Unilateral group.

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

Outcome measures

Outcome measures
Measure	Unilateral n=132 Eyes ELITA - One Eye Treated with ELITA, Fellow Eye Not Treated	Bilateral n=132 Eyes One eye treated with ELITA, fellow eye treated with iFS
Flap Thickness	109.32 microMeter Standard Deviation 6.55	109.77 microMeter Standard Deviation 6.53

Adverse Events

Unilateral

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Bilateral

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Unilateral n=3 participants at risk One eye treated with ELITA only, Fellow Eye Not Treated	Bilateral n=197 participants at risk One eye treated with ELITA, fellow eye treated with iFS
Surgical and medical procedures Miscreated Flap	33.3% 1/3 • During the course of the study until termination (3 months) Adverse events were not monitored or assessed at the eye level and cannot be attributed to a specific intervention. AEs were monitored/ assessed at the participant level. 3 unilaterally treated subjects - 3 eyes in total from 3 participants; 197 bilaterally treated subjects - 394 eyes in total from 197 participants.	0.00% 0/197 • During the course of the study until termination (3 months) Adverse events were not monitored or assessed at the eye level and cannot be attributed to a specific intervention. AEs were monitored/ assessed at the participant level. 3 unilaterally treated subjects - 3 eyes in total from 3 participants; 197 bilaterally treated subjects - 394 eyes in total from 197 participants.
Surgical and medical procedures Epithelium in the interface with a loss of 2 or more lines of BSCVA (>10 ETDRS letters)	0.00% 0/3 • During the course of the study until termination (3 months) Adverse events were not monitored or assessed at the eye level and cannot be attributed to a specific intervention. AEs were monitored/ assessed at the participant level. 3 unilaterally treated subjects - 3 eyes in total from 3 participants; 197 bilaterally treated subjects - 394 eyes in total from 197 participants.	0.51% 1/197 • During the course of the study until termination (3 months) Adverse events were not monitored or assessed at the eye level and cannot be attributed to a specific intervention. AEs were monitored/ assessed at the participant level. 3 unilaterally treated subjects - 3 eyes in total from 3 participants; 197 bilaterally treated subjects - 394 eyes in total from 197 participants.
Surgical and medical procedures Other	66.7% 2/3 • During the course of the study until termination (3 months) Adverse events were not monitored or assessed at the eye level and cannot be attributed to a specific intervention. AEs were monitored/ assessed at the participant level. 3 unilaterally treated subjects - 3 eyes in total from 3 participants; 197 bilaterally treated subjects - 394 eyes in total from 197 participants.	0.51% 1/197 • During the course of the study until termination (3 months) Adverse events were not monitored or assessed at the eye level and cannot be attributed to a specific intervention. AEs were monitored/ assessed at the participant level. 3 unilaterally treated subjects - 3 eyes in total from 3 participants; 197 bilaterally treated subjects - 394 eyes in total from 197 participants.

Additional Information

Brian Pall, Dr.

Johnson & Johnson Surgical Vision

Phone: +1 904 6292289

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER