MyopiaNCT07078799
Wavefront-guided LASIK Surgery Compared to Ray Tracing-Guided LASIK Surgery
A study testing LASIK in people with Myopia and Astigmatism, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- LASIK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- 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) -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Byers Eye Institute at Stanford University School of Medicine
Palo Alto, California, 94303
Edward Manche, MD, 650-498-7020
Edward Manche, MD
About this study
Official title: A Prospective Randomized Comparison of Wavefront-guided LASIK Surgery to Ray Tracing-Guided LASIK Surgery
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.
Read the detailed description
We are comparing the outcomes of wavefront-guided LASIK (laser in-situ keratomileusis) and ray tracing-guided LASIK for nearsightedness with and without astigmatism.
Wavefront aberrometry (a non-contact laser measuring device) is an automated device that measures the refractive status of the eye. This data is then transferred to the laser system and calculates a unique treatment to reduce or eliminate your nearsightedness with and without astigmatism (a non-spherical shape).
One eye will be treated with ray tracing-guided LASIK and the other eye treated with the wavefront-guided LASIK. Each participant will receive both wavefront-guided LASIK and ray-tracing guided LASIK. Both wavefront-guided LASIK and ray tracing-guided LASIK are FDA-approved procedures. Both procedures are being performed according to the FDA-approved labeling.
We plan to enroll up to 70 near-sighted study participants to undergo treatment in this clinical research trial.
The choice of which eye receives ray tracing-guided LASIK surgery and which eye receives wavefront-guided LASIK will be randomized (assigned at random) prior to enrollment.
Participants scheduled to undergo LASIK for the correction of myopia (nearsightedness) will be screened for eligibility. Eligible participants will be examined preoperatively to establish a baseline for ocular condition (the general health and glasses prescription of the eyes). Postoperatively, participants will undergo an ophthalmic evaluation (complete eye examination) at regular intervals as specified in this protocol. Re-treatments (a second operation on the same eye for residual nearsightedness, farsightedness and/or astigmatism) will not be allowed during the first twelve months of this study.. If a participant elects to undergo a re-treatment of the initial LASIK surgery prior to the 12-month post-operative visit, the data after the retreatment procedure will be excluded from the study analysis.
The primary aim of the research is to compare outcomes between the two procedures. All of the procedures performed during the study are considered standard of care for LASIK surgeries.
- Conditions
- Myopia, Astigmatism
- Being tested
- LASIK
- Keywords
- Ray tracing-guided LASIK, Wavefront-guided LASIK
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASIKProcedure or surgery
Wavefront-guided LASIK is being performed in one eye and Ray-tracing guided LASIK is being performed in the fellow eye
LASIKProcedure or surgery
Ray-tracing guided LASIK is being performed in one eye and Wavefront-guided LASIK is being performed in the fellow eye.
| Study group | Role | What they receive |
|---|---|---|
| Wavefront-guided laser ablation | Active comparator | Wavefront-guided LASIK Receives: 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 Receives: Procedure: LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected visual acuity
Uncorrected visual acuity using ETDRS charts
Measured: One year
Secondary outcomes (3)
5 and 25% best corrected low contrast visual acuity
Measurement of the change in 5 and 25% best corrected low contrast visual acuity using ETDRS charts
Measured: 12 months
Achieved versus attempted ablation depth measured by anterior segment OCT
Measurement of achieved ablation depth by comparing preoperative anterior segment OCT to postoperative anterior segment OCT
Measured: One, three and twelve months
Self reported quality of vision and quality of life measures
A validated questionnaire will be administered preoperatively and at postoperative months 3, 6 and 12
Measured: Three, six and twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start20 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward E. Manche, Stanford University
- Investigators
- Edward E Manche, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078799
- Sponsor's protocol ID
- 81344
- Status last verified
- Jan 2026
- First submitted
- 12 Jul 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparison of Wavefront-guided LASIK Surgery to Ray Tracing-Guided LASIK Surgery
- ClinicalTrials.gov ID
- NCT07078799
- Acronym / sponsor ID
- 81344
- Conditions
- Myopia, Astigmatism
- Keywords
- Ray tracing-guided LASIK, Wavefront-guided LASIK
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We are comparing the outcomes of wavefront-guided LASIK (laser in-situ keratomileusis) and ray tracing-guided LASIK for nearsightedness with and without astigmatism.
Wavefront aberrometry (a non-contact laser measuring device) is an automated device that measures the refractive status of the eye. This data is then transferred to the laser system and calculates a unique treatment to reduce or eliminate your nearsightedness with and without astigmatism (a non-spherical shape).
One eye will be treated with ray tracing-guided LASIK and the other eye treated with the wavefront-guided LASIK. Each participant will receive both wavefront-guided LASIK and ray-tracing guided LASIK. Both wavefront-guided LASIK and ray tracing-guided LASIK are FDA-approved procedures. Both procedures are being performed according to the FDA-approved labeling.
We plan to enroll up to 70 near-sighted study participants to undergo treatment in this clinical research trial.
The choice of which eye receives ray tracing-guided LASIK surgery and which eye receives wavefront-guided LASIK will be randomized (assigned at random) prior to enrollment.
Participants scheduled to undergo LASIK for the correction of myopia (nearsightedness) will be screened for eligibility. Eligible participants will be examined preoperatively to establish a baseline for ocular condition (the general health and glasses prescription of the eyes). Postoperatively, participants will undergo an ophthalmic evaluation (complete eye examination) at regular intervals as specified in this protocol. Re-treatments (a second operation on the same eye for residual nearsightedness, farsightedness and/or astigmatism) will not be allowed during the first twelve months of this study.. If a participant elects to undergo a re-treatment of the initial LASIK surgery prior to the 12-month post-operative visit, the data after the retreatment procedure will be excluded from the study analysis.
The primary aim of the research is to compare outcomes between the two procedures. All of the procedures performed during the study are considered standard of care for LASIK surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Wavefront-guided laser ablation | Active comparator | Procedure: LASIKWavefront-guided LASIK |
| Ray tracing-guided LASIK | Active comparator | Procedure: LASIKRay-tracing guided LASIK is being performed in one eye and Wavefront-guided LASIK is being performed in the fellow eye |
Who may qualify
- Ages
- 22 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 22 and older
- People with healthy eyes:
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LASIKWavefront-guided LASIK is being performed in one eye and Ray-tracing guided LASIK is being performed in the fellow eye | Procedure or surgery | Ray tracing-guided LASIK |
| LASIKRay-tracing guided LASIK is being performed in one eye and Wavefront-guided LASIK is being performed in the fellow eye. | Procedure or surgery | Wavefront-guided laser ablation |
Primary outcome
Uncorrected visual acuity
Time frame: One year
Uncorrected visual acuity using ETDRS charts
3 secondary outcomes
5 and 25% best corrected low contrast visual acuity
Time frame: 12 months
Achieved versus attempted ablation depth measured by anterior segment OCT
Time frame: One, three and twelve months
Self reported quality of vision and quality of life measures
Time frame: Three, six and twelve months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edward E Manche, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LASIK in people with Myopia and Astigmatism, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edward E Manche, MD (650 725 5765, cornea@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncorrected visual acuity (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.