NCT03067077

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

Completed NA Results posted Last updated 2 February 2022

What this trial tests

NA trial testing SMILE in Myopia in 44 participants. Completed in 15 March 2021.

Timeline

12 March 2017

Primary endpoint
15 March 2021

15 March 2021

Quick facts

Lead sponsor	Stanford University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	12 March 2017
Primary completion	15 March 2021
Estimated completion	15 March 2021
Sites	1 location across United States

Drugs / interventions tested

• SMILE
• LASIK

Conditions studied

• Myopia — all drugs for Myopia →

Sponsor

Stanford University

Who can join

Adults 22 to 59, any sex, with Myopia. 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.

Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better Primary · One year

ETDRS testing lane

Group	Value	95% CI
SMILE	94
Wavefront-guided LASIK	83

Number of Participant Eyes Losing 2 or More Lines of Corrected Distance Visual Acuity Secondary · One year

ETDRS testing lane

Group	Value	95% CI
SMILE	0
Wavefront-guided LASIK	0

Aberrometry Measurements Secondary · One year

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

Group	Value	95% CI
SMILE	0
Wavefront-guided LASIK	0

Patient Satisfaction Secondary · One year

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

Group	Value	95% CI
SMILE	36
Wavefront-guided LASIK	36

Change in Corneal Sensation Secondary · One year

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

Group	Value	95% CI
SMILE	0
Wavefront-guided LASIK	0

Dry Eye Symptoms as Measured by OSDI Index Secondary · One year

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.

Group	Value	95% CI
SMILE	0
Wavefront-guided LASIK	0

Analysis of Astigmatism Secondary · One year

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

Group	Value	95% CI
SMILE	0
Wavefront-guided LASIK	0

Predictability Secondary · One year

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

+/- 0.50 diopters

Group	Value	95% CI
SMILE	30
Wavefront-guided LASIK	34

+/- 1.0 diopters

Group	Value	95% CI
SMILE	36
Wavefront-guided LASIK	37

Stability Secondary · One year

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

Group	Value	95% CI
SMILE	0
Wavefront-guided LASIK	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SMILE

Serious: 0/44 (0%)

Deaths: 0/44

Wavefront-guided LASIK

Serious: 0/44 (0%)

Deaths: 0/44

Other adverse events (1 terms — click to expand)

Reaction	System	SMILE	Wavefront-guided LASIK
Unable to remove SMILE lenticule	Eye disorders	—	—

Data from ClinicalTrials.gov NCT03067077 adverse events section.

Sponsor's own description

Subjects will undergo SMILE surgery in one eye and LASIK surgery in their other eye to correct myopia.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Prospective, Randomized Contralateral Eye Comparison of Wavefront-Guided Laser In Situ Keratomileusis and Small Incision Lenticule Extraction Refractive Surgeries.
   Chiang B, Valerio GS, Manche EE. · · 2022 · cited 17× · PMID 34788593 · DOI 10.1016/j.ajo.2021.11.013