N/A N=88 Randomized Treatment

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

Myopia

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View on ClinicalTrials.gov: NCT03067077 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2022

Primary outcome: Primary: Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better — 94; 83 percentage of participant eyes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SMILE (Procedure); LASIK (Procedure)
Age: Adult · 22+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better	94; 83	—
SECONDARY Number of Participant Eyes Losing 2 or More Lines of Corrected Distance Visual Acuity	0; 0	—
SECONDARY Aberrometry Measurements	0; 0	—
SECONDARY Patient Satisfaction	36; 36	—
SECONDARY Change in Corneal Sensation	0; 0	—
SECONDARY Dry Eye Symptoms as Measured by OSDI Index	0; 0	—
SECONDARY Analysis of Astigmatism	0; 0	—
SECONDARY Anterior Segment Ocular Coherence Topography Analysis	—	—
SECONDARY Predictability	30; 34; 36; 37	—
SECONDARY Stability	0; 0	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Subjects age 22 and older with healthy eyes. Nearsightedness between -0.75 diopters and -8.00 diopters.
Subjects with up to 3.00 diopters of astigmatism.

Exclusion Criteria

Subjects under the age of 22.
Subjects with excessively thin corneas.
Subjects with topographic evidence of keratoconus.
Subjects with ectatic eye disorders.
Subjects with autoimmune diseases.
Subjects who are pregnant or nursing.
Subjects must have similar levels of nearsightedness in each eye. They can not be more than 1.5 diopter of difference between eyes.
Subjects with 3.25 or more diopters of astigmatism
Subjects must have similar levels of astigmatism in each eye. They can not have more than 0.50 diopters of difference between eyes.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03067077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.