MyopiaPhase 3NCT01663363
Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors
A Phase 3 study testing LASIK correction of myopic refractive errors in people with Myopia, run by Abbott Medical Optics.
Trial summary
The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and effective for the correction of myopic refractive errors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- LASIK correction of myopic refractive errors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Jul 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or greater
- Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
- Uncorrected visual acuity (UCVA) of 20/40 or worse
- Less than 0.75D difference between cycloplegic and manifest refraction sphere.
- Demonstration of refractive stability
- Anticipated post-operative stromal bed thickness of at least 250 microns
- Willing and capable of returning for follow-up examinations for the duration of the study.
Who cannot join
- Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
- Concurrent use of topical or systemic medications that may impair healing
- History of any medical conditions that could affect wound healing
- History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality
- Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)
- Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
About this study
Official title: A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided LASIK Correction of Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4IR™ Excimer Laser
The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and effective for the correction of myopic refractive errors.
- Conditions
- Myopia
- Being tested
- LASIK correction of myopic refractive errors
- Keywords
- refractive, LASIK
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASIK correction of myopic refractive errorsDevice
Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
| Study group | Role | What they receive |
|---|---|---|
| wavefront-guided LASIK | Experimental | LASIK correction of myopic refractive errors. Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System. Receives: Device: LASIK correction of myopic refractive errors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)
Measured: 6 Months
Secondary outcomes (1)
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Optics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kendra Hileman, PhD, Study director, Abbott Medical Optics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663363
- Sponsor's protocol ID
- STAR-110-IDMY
- Status last verified
- Jan 2025
- First submitted
- 9 Aug 2012
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided LASIK Correction of Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4IR™ Excimer Laser
- ClinicalTrials.gov ID
- NCT01663363
- Acronym / sponsor ID
- STAR-110-IDMY
- Conditions
- Myopia
- Keywords
- refractive, LASIK
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Abbott Medical OpticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 Aug 2012 (estimated)
- Results
- Posted 26 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and effective for the correction of myopic refractive errors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| wavefront-guided LASIK | Experimental | Device: LASIK correction of myopic refractive errorsLASIK correction of myopic refractive errors. Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or greater
- Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
- Uncorrected visual acuity (UCVA) of 20/40 or worse
- Less than 0.75D difference between cycloplegic and manifest refraction sphere.
- Demonstration of refractive stability
Key exclusion criteria (6 listed)
- Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
- Concurrent use of topical or systemic medications that may impair healing
- History of any medical conditions that could affect wound healing
- History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality
- Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)
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 |
|---|---|---|
| LASIK correction of myopic refractive errorsSurgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System | Device | wavefront-guided LASIK |
Primary outcome
Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)
Time frame: 6 Months
1 secondary outcome
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kendra Hileman, PhD study director
Abbott Medical Optics
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LASIK correction of myopic refractive errors in people with Myopia, run by Abbott Medical Optics.
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 7 inclusion and 6 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 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA) (time frame: 6 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 4 Feb 2025.