SMILE Surgery in One Eye Compared to Ray Tracing-guided LASIK Surgery in the Fellow Eye

NCT07721714 | Not Yet Recruiting Phase 4 FDA Device

• 2 other identifiers: 79951359910
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Participants will undergo LASIK surgery in one eye using ray tracing guided technology in one eye and LASIK surgery in the other eye using wavefront guided technology. We are comparing outcomes between the two technologies as measured by self reported quality of vision and quality of life outcomes using validated questionnaires before and after surgery. We will also be comparing outcomes between the two technologies including measurement of low contrast visual acuity,and best spectacle corrected visual acuity.

Conditions

Myopia; Astigmatism

Keywords

Ray-tracing; LASIK; SMILE

Outcome Measures

Primary Outcomes (1)

• Change in corrected distance visual acuity

  The primary endpoint will be the gain in lines of corrected distance visual acuity (CDVA) at the postoperative month three follow-up compared with preoperative baseline.

  Three months

Secondary Outcomes (4)

• Change in 5 and 25% low contrast CDVA

  Three months

• Change in patient self reported quality of vision and life

  Three months

• Corneal epithelial thickness changes

  Three months

• Change in higher order aberrations

  Three months

Study Arms (2)

Ray tracing guided LASIK surgery

ACTIVE COMPARATOR

LASIK

Device: Ray tracing guided LASIK surgery

SMILE surgery

ACTIVE COMPARATOR

SMILE

Device: Ray tracing guided LASIK surgery

Interventions

Ray tracing guided LASIK surgery DEVICE

LASIK

Ray tracing guided LASIK surgery; SMILE surgery

Eligibility Criteria

• Age: 22 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects age 22 and older with healthy eyes. Nearsightedness between -1.00 diopters and -8.00 diopters.
• Subjects with less than or equal 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 ectactic 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 more than 3.00 diopters of astigmatism Subjects must have similar levels of astigmatism in each eye. They can not have more than 0.75 diopters of difference between eyes.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Byers Eye Institute

Palo Alto, California, 94303, United States

Location

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Edward E Manche, MD

CONTACT

1-650-498-7020; edward.manche@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Model Details: Prospective, randomized, contralateral fellow eye study

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): August 5, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): July 31, 2029
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)