Trial Outcomes & Findings for A Comparison of LASIK Outcomes Using Two Femtosecond Lasers (NCT NCT03063164)

Results Overview

Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

At post-operative month 12

Results posted on

2021-12-14

Participant Flow

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Intralase IFS Eye Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.	Visumax Eye Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
Overall Study STARTED	7 7	7 7
Overall Study COMPLETED	7 7	7 7
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of LASIK Outcomes Using Two Femtosecond Lasers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=14 Eyes Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	2 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: At post-operative month 12

Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts

Outcome measures

Outcome measures
Measure	Intralase IFS Eye n=7 Eyes Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.	Visumax Eye n=7 Eyes Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
ETDRS Uncorrected Visual Acuity	5 Eyes	5 Eyes

SECONDARY outcome

Timeframe: At postoperative month one

Population: Data were corrupted and could not be analyzed

Anterior segment ocular coherence tomography

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At postoperative month twelve

Cochet Bonnet Asthesiometry is measured on a scale of 1-6. Scores of 5 and above are considered normal.

Outcome measures

Outcome measures
Measure	Intralase IFS Eye n=7 Eyes Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.	Visumax Eye n=7 Eyes Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
Cochet Bonnet Asthesiometry Measurement of Corneal Sensation Score of greater than or equal to 5	7 Eyes	7 Eyes
Cochet Bonnet Asthesiometry Measurement of Corneal Sensation Score of less than 5	0 Eyes	0 Eyes

SECONDARY outcome

Timeframe: Postoperative month 12

Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts

Outcome measures

Outcome measures
Measure	Intralase IFS Eye n=7 Eyes Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.	Visumax Eye n=7 Eyes Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
Best Spectacle Corrected Visual Acuity	0 Eyes	0 Eyes

SECONDARY outcome

Timeframe: One three, six and twelve months

Population: The data were corrupted and could not be analyzed

Aberrometry images will be obtained on the iDesign aberrometer

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Intraoperative (Approximately 1 minute after completion of surgery)

Participants were asked if they preferred having LASIK surgery with either the Visumax laser, the Intralase iFS laser or had no preference between the two lasers.

Outcome measures

Outcome measures
Measure	Intralase IFS Eye n=7 Participants Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.	Visumax Eye Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye.
Questionnaire Measuring Patient Preference for Laser Device Preferred Visumax	3 Participants	—
Questionnaire Measuring Patient Preference for Laser Device Preferred Intralase IFS	2 Participants	—
Questionnaire Measuring Patient Preference for Laser Device No preference	2 Participants	—

SECONDARY outcome

Timeframe: One month, three months, six months and twelve months

Population: Questionnaire data were corrupted and could not be analyzed.

PROWL study questionnaire

Outcome measures

Outcome data not reported

Adverse Events

Intralase IFS Eye

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Visumax Eye

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Edward E. Manche

Stanford University School of Medicine

Phone: 6507255765

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place