MyopiaNCT05588882
Wavefront-guided vs. Topography-guided LASIK
A study testing Wavefront-guided LASIK and Wavefront-guided in people with Myopia, run by Stanford University at 1 site in United States.
Trial summary
The study is comparing outcomes of wavefront-guided LASIK to topography-guided LASIK in a randomized contralateral fellow eye study in myopic participants. Read more about this study
- Who is it for?
- Ages 22 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Wavefront-guided LASIK and Wavefront-guided
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2022to 24 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subjects ages 22 to 59with healthy eyes. Nearsightedness between -1.00 diopters and -9.00 diopters.
- Subjects with less than or equal to 3.00 diopters of astigmatism.
Who cannot join
- Subjects under the age of 22 and over the age of 59
- 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.
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- Subjects must have similar levels of nearsightedness in each eye. They cannot 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 cannot have more than 1.00 diopters of difference between eyes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Palo Alto, California, 94303
About this study
Official title: A Prospective Randomized Comparison of Topography-Guided LASIK Surgery to Wavefront-Guided LASIK Surgery
The study is comparing outcomes of wavefront-guided LASIK to topography-guided LASIK in a randomized contralateral fellow eye study in myopic participants.
Read the detailed description
The purpose of the study is to compare the results of wavefront-guided LASIK surgery to topography-guided LASIK surgery in participants with nearsightedness with or without astigmatism
Three FDA-approved laser devices are being used for the study.
Two excimer lasers are being used for the study. The excimer laser is used to perform the reshaping of the cornea under a LASIK flap to correct nearsightedness, farsightedness and astigmatism. The two lasers being utilized are the Johnson and Johnson Visx CustomVue excimer laser and the Alcon Allegretto laser in the study. Both have received FDA-approval via a PMA pathway.
One femtosecond laser is being used in the study. The femtosecond laser is used to create the LASIK flap during the first part of the LASIK procedure. The Intralase iFS150 femtosecond laser is being used in the study. The femtosecond laser received FDA- approval via a 510k pathway.
All three lasers are being used according to their approved indications.
- Conditions
- Myopia
- Being tested
- Wavefront-guided LASIK, Wavefront-guided
- Keywords
- wavefront-guided, topography-guided, LASIK
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wavefront-guided LASIKProcedure or surgery
Also called Topography-guided LASIK
Topography-guided utilizes topography mapping to perform the ablation
Wavefront-guidedProcedure or surgery
Wavefront-guided utilizes aberrometry to perform the ablation
| Study group | Role | What they receive |
|---|---|---|
| Wavefront-guided LASIK | Active comparator | Wavefront-guided LASIK for myopia and myopic astigmatism Receives: Procedure: Wavefront-guided LASIK |
| Topography-guided LASIK | Active comparator | Topography-guided LASIK for myopia and myopic astigmatism Receives: Procedure: Wavefront-guided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of eyes achieving uncorrected visual acuity
Percentage of eyes achieving an uncorrected visual acuity of 20/40, 20/25 ,20/20, 20/16, 20/12.5 and 20/10 at post-operative month twelve
Measured: One year
Secondary outcomes (4)
Percentage of eyes with a change in two or more lines of corrected visual acuity
Percentage of eyes gaining or losing two or more lines of corrected visual acuity Percentage of eyes gaining or losing 2 or more lines of corrected distance visual acuity
Measured: One year
Predictability
Percentage of eyes within +/- 0.50 and +/- 1.00 diopters of the intended corrected
Measured: One year
Patient Quality of Vision
Percentage of patients preferring the eye that underwent either Wavefront-guided or Topography-guided LASIK
Measured: One year
Change in corneal epithelial thickness
We will be measuring the average change in central corneal epithelial thickness from preoperative to post-operative month12 in eyes undergoing Wavefront-guided LASIK and Topography-guided LASIK
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start19 Oct 2022
- Primary completion24 Sep 2024
- Study completion24 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Model description
- Participants contribute one eye to each study arm
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
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
- NCT05588882
- Sponsor's protocol ID
- 63961
- Status last verified
- Sep 2024
- First submitted
- 17 Oct 2022
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lu L, Manche E. Prospective, randomized, contralateral eye comparison of wavefront-guided and topography-guided LASIK. J Cataract Refract Surg. 2025 Oct 1;51(10):889-894. doi: 10.1097/j.jcrs.0000000000001703.
PubMed 40778939
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparison of Topography-Guided LASIK Surgery to Wavefront-Guided LASIK Surgery
- ClinicalTrials.gov ID
- NCT05588882
- Acronym / sponsor ID
- 63961
- Conditions
- Myopia
- Keywords
- wavefront-guided, topography-guided, LASIK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 20 Oct 2022 (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.
The study is comparing outcomes of wavefront-guided LASIK to topography-guided LASIK in a randomized contralateral fellow eye study in myopic participants.
Detailed description
The purpose of the study is to compare the results of wavefront-guided LASIK surgery to topography-guided LASIK surgery in participants with nearsightedness with or without astigmatism
Three FDA-approved laser devices are being used for the study.
Two excimer lasers are being used for the study. The excimer laser is used to perform the reshaping of the cornea under a LASIK flap to correct nearsightedness, farsightedness and astigmatism. The two lasers being utilized are the Johnson and Johnson Visx CustomVue excimer laser and the Alcon Allegretto laser in the study. Both have received FDA-approval via a PMA pathway.
One femtosecond laser is being used in the study. The femtosecond laser is used to create the LASIK flap during the first part of the LASIK procedure. The Intralase iFS150 femtosecond laser is being used in the study. The femtosecond laser received FDA- approval via a 510k pathway.
All three lasers are being used according to their approved indications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants contribute one eye to each study arm
| Arm | Type | Receives |
|---|---|---|
| Wavefront-guided LASIK | Active comparator | Procedure: Wavefront-guided LASIKWavefront-guided LASIK for myopia and myopic astigmatism |
| Topography-guided LASIK | Active comparator | Procedure: Wavefront-guidedTopography-guided LASIK for myopia and myopic astigmatism |
Who may qualify
- Ages
- 22 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects ages 22 to 59with healthy eyes. Nearsightedness between -1.00 diopters and -9.00 diopters.
- Subjects with less than or equal to 3.00 diopters of astigmatism.
Key exclusion criteria (9 listed)
- Subjects under the age of 22 and over the age of 59
- 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 |
|---|---|---|
| Wavefront-guided LASIKAlso: Topography-guided LASIKTopography-guided utilizes topography mapping to perform the ablation | Procedure or surgery | Wavefront-guided LASIK |
| Wavefront-guidedWavefront-guided utilizes aberrometry to perform the ablation | Procedure or surgery | Topography-guided LASIK |
Primary outcome
Percentage of eyes achieving uncorrected visual acuity
Time frame: One year
Percentage of eyes achieving an uncorrected visual acuity of 20/40, 20/25 ,20/20, 20/16, 20/12.5 and 20/10 at post-operative month twelve
4 secondary outcomes
Percentage of eyes with a change in two or more lines of corrected visual acuity
Time frame: One year
Predictability
Time frame: One year
Patient Quality of Vision
Time frame: One year
Change in corneal epithelial thickness
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Derived from this study: PubMed 40778939Lu L, Manche E. Prospective, randomized, contralateral eye comparison of wavefront-guided and topography-guided LASIK. J Cataract Refract Surg. 2025 Oct 1;51(10):889-894. doi: 10.1097/j.jcrs.0000000000001703.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Wavefront-guided LASIK and Wavefront-guided in people with Myopia, 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 2 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: finished, as of the sponsor's last update on 26 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of eyes achieving 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?
On the ClinicalTrials.gov record for NCT05588882, which also lists 1 linked publication.
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 26 Sep 2024.