Wavefront-guided LASIK Surgery Compared to Ray Tracing-Guided LASIK Surgery

NCT07078799 | Recruiting

• 1 other identifier: 81344
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

We are enrolling participants aged 22 and older to have LASIK surgery in both eyes. We will perform wavefront-guided LASIK in one eye and ray tracing-guided LASIK in the fellow eye of each participant. We are trying to see if there are any differences in the efficacy between the two types of LASIK procedures.

Conditions

Myopia; Astigmatism

Keywords

Ray tracing-guided LASIK; Wavefront-guided LASIK

Outcome Measures

Primary Outcomes (1)

• Uncorrected visual acuity

  Uncorrected visual acuity using ETDRS charts

  One year

Secondary Outcomes (3)

• 5 and 25% best corrected low contrast visual acuity

  12 months

• Achieved versus attempted ablation depth measured by anterior segment OCT

  One, three and twelve months

• Self reported quality of vision and quality of life measures

  Three, six and twelve months

Study Arms (2)

Wavefront-guided laser ablation

ACTIVE COMPARATOR

Wavefront-guided LASIK

Procedure: LASIK

Ray tracing-guided LASIK

ACTIVE COMPARATOR

Ray-tracing guided LASIK is being performed in one eye and Wavefront-guided LASIK is being performed in the fellow eye

Procedure: LASIK

Interventions

LASIK PROCEDURE

Wavefront-guided LASIK is being performed in one eye and Ray-tracing guided LASIK is being performed in the fellow eye

Ray tracing-guided LASIK

Eligibility Criteria

• Age: 22 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 22 and older
• People with healthy eyes:
• No abnormal corneal shape
• No excessively thin corneas
• No eye diseases such as glaucoma or cataracts
• Nearsightedness between -1.00 diopters and -10.00 diopters.
• Subjects with less than or equal to 3.00 diopters of astigmatism.
• Subjects must have similar levels of nearsightedness in each eye.

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 at the time of surgery. (The FDA-approved labelling indications for LASIK specifically excludes patients who are pregnant or nursing. There is no strict prohibition not to become pregnant during the one year study period)
• They can not be more than 1.5 diopter of difference between eyes.
• Subjects with more than 3.00 diopters of astigmatism
• Subjects with disimilar 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 at Stanford University School of Medicine

Palo Alto, California, 94303, United States

RECRUITING

MeSH Terms

Conditions

Myopia; Astigmatism

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, Laser; Laser Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Keratectomy; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures

Study Officials

• Edward E Manche, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward E Manche, MD

CONTACT

650 725 5765; cornea@stanford.edu

Theresa Enriquez, HS

CONTACT

650 498 7020; tenriquez@stanfordhealthcare.org

Study Design

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

Model Details: This is a prospective, randomized, contralateral fellow eye study comparing ray-tracing guided LASIK in one eye to wavefront-guided LASIK in the fellow eye of participants

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: July 22, 2025
• Study Start: January 20, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (1)