MyopiaNCT01682434
Wavefront-guided LASIK for Correction of Myopia
A study testing Laser in situ keratomileusis (LASIK) in people with Myopia, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Laser in situ keratomileusis is a successful procedure for the treatment of low to moderate myopia. Advances over the last decade have allowed LASIK to also correct higher order wavefront aberrations. In low myopia, there seem to be a minor effect of such wavefront-guided treatment. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Myopia
- What is being tested?
- Laser in situ keratomileusis (LASIK)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- May 2011to Jan 2014
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20 to 50 years
- No known ocular or systemic disease
- Not pregnant or breastfeeding
- Myopia between -6.0 and -10.0 diopters
- Astigmatism below 2.0 diopters
- Difference of less than 1.0 diopters in spherical equivalent between eyes
- Normal corneal topography
- Corneal thickness sufficient for planned treatment
Who cannot join
- Patients that do not fulfill inclusion criteria
- Insufficient quality of ocular wavefront measurement
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Ophthalmology, Aarhus University Hospital
Aarhus, DK-8000
About this study
Laser in situ keratomileusis is a successful procedure for the treatment of low to moderate myopia.
Advances over the last decade have allowed LASIK to also correct higher order wavefront aberrations. In low myopia, there seem to be a minor effect of such wavefront-guided treatment. However, it remains to be established whether there is a beneficial effect in higher degrees of myopia.
The study aims to determine whether myopic subjects (-6 to -10 diopters) with higher-than-average preoperative higher-order aberrations have benefit of wavefront-guided treatment. Subjects are randomized to wavefront-guided treatment in one eye, and conventional treatment in the other.
- Conditions
- Myopia
- Being tested
- Laser in situ keratomileusis (LASIK)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser in situ keratomileusis (LASIK)Procedure or surgery
Also called Device: Carl Zeiss Meditec Visumax femtosecond LASIK, Device: Carl Zeiss Meditec MEL-80 excimer laser.
Wavefront guided treatment in one eye, conventional in the other.
| Study group | Role | What they receive |
|---|---|---|
| Wavefront-guided LASIK | Active comparator | One eye will be randomized to wavefront-guided treatment. The other receives conventional LASIK. Receives: Procedure: Laser in situ keratomileusis (LASIK) |
| Conventional LASIK | Active comparator | One eye will receive wavefront-guided LASIK. The other eye receives conventional treatment. Receives: Procedure: Laser in situ keratomileusis (LASIK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: 12 months
Secondary outcomes (1)
Ocular higher order aberrations
Hartmann-Schack wavefront aberrometry using the Zeiss Meditec WASCA
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startMay 2011
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Institution changed surgical method to small-incision lenticule extraction. Study never started.
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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Ivarsen, Aarhus University Hospital
- Investigators
- Anders Ivarsen, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682434
- Sponsor's protocol ID
- AUH_LASIK
- Status last verified
- Oct 2026
- First submitted
- 4 Sep 2012
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wavefront-guided LASIK for Correction of Myopia
- ClinicalTrials.gov ID
- NCT01682434
- Acronym / sponsor ID
- AUH_LASIK
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Institution changed surgical method to small-incision lenticule extraction. Study never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Sep 2012 (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.
Laser in situ keratomileusis is a successful procedure for the treatment of low to moderate myopia.
Advances over the last decade have allowed LASIK to also correct higher order wavefront aberrations. In low myopia, there seem to be a minor effect of such wavefront-guided treatment. However, it remains to be established whether there is a beneficial effect in higher degrees of myopia.
The study aims to determine whether myopic subjects (-6 to -10 diopters) with higher-than-average preoperative higher-order aberrations have benefit of wavefront-guided treatment. Subjects are randomized to wavefront-guided treatment in one eye, and conventional treatment in the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wavefront-guided LASIK | Active comparator | Procedure: Laser in situ keratomileusis (LASIK)One eye will be randomized to wavefront-guided treatment. The other receives conventional LASIK. |
| Conventional LASIK | Active comparator | Procedure: Laser in situ keratomileusis (LASIK)One eye will receive wavefront-guided LASIK. The other eye receives conventional treatment. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 20 to 50 years
- No known ocular or systemic disease
- Not pregnant or breastfeeding
- Myopia between -6.0 and -10.0 diopters
- Astigmatism below 2.0 diopters
Key exclusion criteria (2 listed)
- Patients that do not fulfill inclusion criteria
- Insufficient quality of ocular wavefront measurement
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 |
|---|---|---|
| Laser in situ keratomileusis (LASIK)Also: Device: Carl Zeiss Meditec Visumax femtosecond LASIK, Device: Carl Zeiss Meditec MEL-80 excimer laser.Wavefront guided treatment in one eye, conventional in the other. | Procedure or surgery | Conventional LASIK, Wavefront-guided LASIK |
Primary outcome
Visual acuity
Time frame: 12 months
1 secondary outcome
Ocular higher order aberrations
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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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.
Anders Ivarsen, MD, PhD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser in situ keratomileusis (LASIK) in people with Myopia, run by Aarhus University Hospital at 1 site in Denmark.
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 2 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: withdrawn, as of the sponsor's last update on 28 Oct 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 Denmark. 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 was withdrawn before enrolling participants, so there are no results.
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?
Visual acuity (time frame: 12 months). 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 28 Oct 2026.