NearsightednessNCT02565537
High Resolution Wavefront-guided vs. Wavefront Optimized LASIK
A study testing LASIK in people with Nearsightedness and Astigmatism, run by Stanford University at 1 site in United States.
Trial summary
The investigators are comparing outcomes of LASIK surgery using a high definition wavefront-guided laser to a wavefront-optimized laser in patients with nearsightedness with and without astigmatism. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nearsightedness, 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
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 1 Apr 2025
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects age 21 and older with healthy eyes.
- Nearsightedness between -0.25 diopters and -11.00 diopters with or without astigmatism of up to 5.00 diopters.
Who cannot join
- Subjects under the age of 21.
- Patients with excessively thin corneas.
- Patients with topographic evidence of keratoconus.
- Patients with ectatic eye disorders.
- Patients with autoimmune diseases.
- Patients who are pregnant or nursing.
- Patients must have similar levels of nearsightedness and farsightedness in each eye. They can not be more than 1.5 diopter of difference between eyes.
- Patients must have similar levels of astigmatism in each eye. They can not have more than 1.5 diopter 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 the AMO CustomVue to the Alcon Wavelight in Patients Undergoing LASIK
The investigators are comparing outcomes of LASIK surgery using a high definition wavefront-guided laser to a wavefront-optimized laser in patients with nearsightedness with and without astigmatism.
Read the detailed description
The patients will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the patient from the study, then the investigators will inform the patient and make an appropriate referral. if the patient is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. The patient will undergo bilateral simultaneous eye surgery. Which eye is treated with the CustomVue and which eye is treated with Wavelight will be randomized so there is a 50% chance for either eye to receive one treatment. The patients will be seen on the day of surgery, post op day one, one month, three months, six months and one year. The patient will receive topical antibiotics in each eye for one week following the procedure. The patient will receive pred forte 1% ophthalmic drops for one week after treatment. The patient will also receive vigamox ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing LASIK surgery.
- Conditions
- Nearsightedness, Astigmatism
- Being tested
- 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
WFG vs. WFO LASIK
| Study group | Role | What they receive |
|---|---|---|
| iDesign WFG LASIK | Active comparator | Wavefront-guided LASIK Receives: Procedure: LASIK |
| Wavelight WFO LASIK | Active comparator | Wavefront-optimized LASIK Receives: Procedure: LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected visual acuity
Measured: Twelve months
Secondary outcomes (5)
Quality of vision and quality of life using the QoV questionnaire
Measured: One month, three months, six months and twelve months
Changes in higher order aberrations (Coma, trefoil, spherical aberration, total higher order RMS)
Measured: One day, one month, three months, six months and twelve months
Predictability of refractive outcomes (Percentage of eyes +/- 0.25 diopters, +/- 0.50 diopters and +/- 1.00 diopters of the intended correction)
Measured: One, three, six and twelve months
Change in best spectacle corrected visual acuity
Measured: One, three, six and twelve months
Vector analysis of astigmatic outcomes (The Alpins method looking at Target induced astigmatism, Surgical induced astigmatism, Index of Success
Measured: One, 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 posted1 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion30 Jun 2021
- Study completion1 Apr 2025
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 NearsightednessStudies 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
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT02565537
- Sponsor's protocol ID
- 34288
- Status last verified
- Apr 2025
- First submitted
- 28 Sep 2015
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34788593
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparison of the AMO CustomVue to the Alcon Wavelight in Patients Undergoing LASIK
- ClinicalTrials.gov ID
- NCT02565537
- Acronym / sponsor ID
- 34288
- Conditions
- Nearsightedness, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 1 Oct 2015 (estimated)
- 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 investigators are comparing outcomes of LASIK surgery using a high definition wavefront-guided laser to a wavefront-optimized laser in patients with nearsightedness with and without astigmatism.
Detailed description
The patients will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the patient from the study, then the investigators will inform the patient and make an appropriate referral. if the patient is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. The patient will undergo bilateral simultaneous eye surgery. Which eye is treated with the CustomVue and which eye is treated with Wavelight will be randomized so there is a 50% chance for either eye to receive one treatment. The patients will be seen on the day of surgery, post op day one, one month, three months, six months and one year. The patient will receive topical antibiotics in each eye for one week following the procedure. The patient will receive pred forte 1% ophthalmic drops for one week after treatment. The patient will also receive vigamox ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing LASIK surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iDesign WFG LASIK | Active comparator | Procedure: LASIKWavefront-guided LASIK |
| Wavelight WFO LASIK | Active comparator | Procedure: LASIKWavefront-optimized LASIK |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects age 21 and older with healthy eyes.
- Nearsightedness between -0.25 diopters and -11.00 diopters with or without astigmatism of up to 5.00 diopters.
Key exclusion criteria (8 listed)
- Subjects under the age of 21.
- Patients with excessively thin corneas.
- Patients with topographic evidence of keratoconus.
- Patients with ectatic eye disorders.
- Patients 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 |
|---|---|---|
| LASIKWFG vs. WFO LASIK | Procedure or surgery | Wavelight WFO LASIK, iDesign WFG LASIK |
Primary outcome
Uncorrected visual acuity
Time frame: Twelve months
5 secondary outcomes
Quality of vision and quality of life using the QoV questionnaire
Time frame: One month, three months, six months and twelve months
Changes in higher order aberrations (Coma, trefoil, spherical aberration, total higher order RMS)
Time frame: One day, one month, three months, six months and twelve months
Predictability of refractive outcomes (Percentage of eyes +/- 0.25 diopters, +/- 0.50 diopters and +/- 1.00 diopters of the intended correction)
Time frame: One, three, six and twelve months
Change in best spectacle corrected visual acuity
Time frame: One, three, six and twelve months
Vector analysis of astigmatic outcomes (The Alpins method looking at Target induced astigmatism, Surgical induced astigmatism, Index of Success
Time frame: One, three six and twelve months
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 24 Apr 2025.
- Background: PubMed 34788593Chiang 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.
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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 LASIK in people with Nearsightedness 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 2 inclusion and 8 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 24 Apr 2025. 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?
Uncorrected visual acuity (time frame: Twelve months). 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 NCT02565537, 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 24 Apr 2025.