NCT03067077

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

March 12, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
11 months until next milestone

Results Posted

Study results publicly available

February 2, 2022

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

4 years

First QC Date

February 16, 2017

Results QC Date

November 29, 2021

Last Update Submit

January 5, 2022

Conditions

Myopia

Keywords

SMILELASIKMyopiaWavefront-guided

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participant Eyes With an Uncorrected Visual Acuity of 20/20 or Better

    ETDRS testing lane

    One year

Secondary Outcomes (9)

  • Number of Participant Eyes Losing 2 or More Lines of Corrected Distance Visual Acuity

    One year

  • Aberrometry Measurements

    One year

  • Patient Satisfaction

    One year

  • Change in Corneal Sensation

    One year

  • Dry Eye Symptoms as Measured by OSDI Index

    One year

  • +4 more secondary outcomes

Study Arms (2)

SMILE

ACTIVE COMPARATOR

SMILE surgery

Procedure: SMILEProcedure: LASIK

Wavefront-guided LASIK

ACTIVE COMPARATOR

Wavefront-guided LASIK

Procedure: SMILEProcedure: LASIK

Interventions

SMILEPROCEDURE

SMILE surgery

SMILEWavefront-guided LASIK
LASIKPROCEDURE

LASIK surgery

SMILEWavefront-guided LASIK

Eligibility Criteria

Age22 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

Location

Related Publications (2)

  • 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. 2022 May;237:211-220. doi: 10.1016/j.ajo.2021.11.013. Epub 2021 Nov 14.

    PMID: 34788593RESULT

  • Ma KK, Manche EE. Patient-reported quality of vision in a prospective randomized contralateral-eye trial comparing LASIK and small-incision lenticule extraction. J Cataract Refract Surg. 2023 Apr 1;49(4):348-353. doi: 10.1097/j.jcrs.0000000000001127.

    PMID: 36539217DERIVED

MeSH Terms

Conditions

Myopia

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, LaserLaser TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeKeratectomyRefractive Surgical ProceduresOphthalmologic Surgical Procedures

Results Point of Contact

Title
Edward E. Manche
Organization
Stanford University School of Medcine
edward.manche@stanford.edu
6507255765

Study Officials

  • Edward E Manche, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Ophthalmology

Study Record Dates

First Submitted

February 16, 2017

First Posted

March 1, 2017

Study Start

March 12, 2017

Primary Completion

March 15, 2021

Study Completion

March 15, 2021

Last Updated

February 2, 2022

Results First Posted

February 2, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)