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

Myopia Clinical Trial

Official title:

A Prospective, Randomized Comparison of SMILE Surgery to Wavefront-guided LASIK Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067077
• Other study ID #: 39587
• Status: Completed
• Phase: N/A
• Start date: March 12, 2017
• Est. completion date: March 15, 2021

Study information

• Verified date: January 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Subjects will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the subject from the study, then we will inform the patient and make an appropriate referral. if the subject is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. Subjects will undergo bilateral simultaneous eye surgery. Which eye is treated with the WFG-LASIK and which eye is treated with SMILE will be randomized so there is a 50% chance for either eye to receive one treatment. Subjects will be seen on the day of surgery, post op day one, one week, one month, three months, six months and one year. Subjects will receive topical antibiotics in each eye for one week following the procedure. Subjects will receive topical steroid ophthalmic drops for one week after treatment. Subjects will also receive topical antibiotic ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of subjects undergoing LASIK and SMILE surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Procedure:
• SMILE
SMILE surgery
• LASIK
LASIK surgery

Locations

Country	Name	City	State
United States	Byers Eye Institute at Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chiang B, Valerio GS, Manche EE. Prospective, Randomized Contralateral Eye Comparison of Wavefront-Guided Laser In Situ Keratomileusis and Small Incision Lenticule Extraction Refractive Surgeries. Am J Ophthalmol. 2021 Nov 14;237:211-220. doi: 10.1016/j.a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better	ETDRS testing lane	One year
Secondary	Number of Participant Eyes Losing 2 or More Lines of Corrected Distance Visual Acuity	ETDRS testing lane	One year
Secondary	Aberrometry Measurements	Increase in total higher order RMS (root mean squared) by greater than 0.5 microns	One year
Secondary	Patient Satisfaction	Percentage of patients satisfied with surgery. Patients were asked yes or no.	One year
Secondary	Change in Corneal Sensation	A decrease in corneal sensation of more than 4 cm as measured by Cochet-Bonnet Aesthesiometry	One year
Secondary	Dry Eye Symptoms as Measured by OSDI Index	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.	One year
Secondary	Analysis of Astigmatism	Participant eyes with an increase in astigmatism of greater than 1.0 diopter	One year
Secondary	Anterior Segment Ocular Coherence Topography Analysis	Humphrey Visante AS OCT	One year
Secondary	Predictability	Number of eyes within +/- 0.5 and +/- 1.00 diopter of the intended correction	One year
Secondary	Stability	Change in refractive error greater than one diopter over 1 to 12 months	One year