Trial Outcomes & Findings for A Prospective, Contralateral, Eye to Eye Comparison of SMILE Surgery to LASIK Surgery (NCT NCT03067077)

Results Overview

ETDRS testing lane

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

One year

Results posted on

2022-02-02

Participant Flow

Enrolled participants were to receive SMILE surgery in one eye and LASIK surgery in their fellow eye

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	SMILE SMILE surgery	Wavefront-guided LASIK Wavefront-guided LASIK
Overall Study STARTED	44 44	44 44
Overall Study Received Surgery	40 40	39 39
Overall Study COMPLETED	37 37	37 37
Overall Study NOT COMPLETED	7 7	7 7

Reasons for withdrawal

Reasons for withdrawal
Measure	SMILE SMILE surgery	Wavefront-guided LASIK Wavefront-guided LASIK
Overall Study Did not receive surgery	4	5
Overall Study Lost to Follow-up	3	2

Baseline Characteristics

A Prospective, Contralateral, Eye to Eye Comparison of SMILE Surgery to LASIK Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=44 Participants Participants receive SMILE surgery in one eye and Wavefront-guided LASIK in the fellow eye.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Race/Ethnicity, Customized Asian	19 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	18 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants
Race/Ethnicity, Customized Indian	4 Participants n=5 Participants
Race/Ethnicity, Customized Pacific Islander	1 Participants n=5 Participants
Region of Enrollment United States	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Population: Participants who completed 12 month follow-up

ETDRS testing lane

Outcome measures

Outcome measures
Measure	SMILE n=37 Eyes SMILE surgery	Wavefront-guided LASIK n=37 Eyes Wavefront-guided LASIK
Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better	94 percentage of participant eyes	83 percentage of participant eyes

SECONDARY outcome

Timeframe: One year

Population: Participants who completed the 12 month follow-up

ETDRS testing lane

Outcome measures

Outcome measures
Measure	SMILE n=37 Eyes SMILE surgery	Wavefront-guided LASIK n=37 Eyes Wavefront-guided LASIK
Number of Participant Eyes Losing 2 or More Lines of Corrected Distance Visual Acuity	0 Eyes	0 Eyes

SECONDARY outcome

Timeframe: One year

Population: Participants who completed 12 months follow-up

Increase in total higher order RMS (root mean squared) by greater than 0.5 microns

Outcome measures

Outcome measures
Measure	SMILE n=37 Eyes SMILE surgery	Wavefront-guided LASIK n=37 Eyes Wavefront-guided LASIK
Aberrometry Measurements	0 Eyes	0 Eyes

SECONDARY outcome

Timeframe: One year

Population: Participants who completed 12 months follow-up

Percentage of patients satisfied with surgery. Patients were asked yes or no.

Outcome measures

Outcome measures
Measure	SMILE n=37 Participants SMILE surgery	Wavefront-guided LASIK n=37 Participants Wavefront-guided LASIK
Patient Satisfaction	36 Participants	36 Participants

SECONDARY outcome

Timeframe: One year

Population: Participants who completed 12 months follow-up

A decrease in corneal sensation of more than 4 cm as measured by Cochet-Bonnet Aesthesiometry

Outcome measures

Outcome measures
Measure	SMILE n=37 Eyes SMILE surgery	Wavefront-guided LASIK n=37 Eyes Wavefront-guided LASIK
Change in Corneal Sensation	0 Eyes	0 Eyes

SECONDARY outcome

Timeframe: One year

Population: Patients who completed 12 months follow-up

Worsening of ocular surface disease index (OSDI) score of greater than 25. The overall OSDI score defined the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.

Outcome measures

Outcome measures
Measure	SMILE n=37 Participants SMILE surgery	Wavefront-guided LASIK n=37 Participants Wavefront-guided LASIK
Dry Eye Symptoms as Measured by OSDI Index	0 Participants	0 Participants

SECONDARY outcome

Timeframe: One year

Population: Participants with 12 months follow-up

Participant eyes with an increase in astigmatism of greater than 1.0 diopter

Outcome measures

Outcome measures
Measure	SMILE n=37 Eyes SMILE surgery	Wavefront-guided LASIK n=37 Eyes Wavefront-guided LASIK
Analysis of Astigmatism	0 Eyes	0 Eyes

SECONDARY outcome

Timeframe: One year

Population: The outcome could not be analyzed because the data were corrupted

Humphrey Visante AS OCT

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Population: Participants who completed 12 months follow-up

Number of eyes within +/- 0.5 and +/- 1.00 diopter of the intended correction

Outcome measures

Outcome measures
Measure	SMILE n=37 Eyes SMILE surgery	Wavefront-guided LASIK n=37 Eyes Wavefront-guided LASIK
Predictability +/- 0.50 diopters	30 Eyes	34 Eyes
Predictability +/- 1.0 diopters	36 Eyes	37 Eyes

SECONDARY outcome

Timeframe: One year

Population: Participants who completed twelve months follow-up

Change in refractive error greater than one diopter over 1 to 12 months

Outcome measures

Outcome measures
Measure	SMILE n=37 Eyes SMILE surgery	Wavefront-guided LASIK n=37 Eyes Wavefront-guided LASIK
Stability	0 Eyes	0 Eyes

Adverse Events

SMILE

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Wavefront-guided LASIK

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SMILE n=44 participants at risk SMILE surgery	Wavefront-guided LASIK n=44 participants at risk Wavefront-guided LASIK
Eye disorders Unable to remove SMILE lenticule	2.3% 1/44 • 12 months Adverse events are reported per participant	0.00% 0/44 • 12 months Adverse events are reported per participant

Additional Information

Edward E. Manche

Stanford University School of Medcine

Phone: 6507255765

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place