AstigmatismNCT01675492
Safety and Effectiveness of Wavefront-guided LASIK for the Correction of Mixed Astigmatism
A study testing LASIK in people with Astigmatism, run by Abbott Medical Optics.
Trial summary
To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Astigmatism
- What is being tested?
- LASIK
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 6 Dec 2012to 22 Nov 2016
- Phase
- Interventional
- 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
- At least 18 years of age at the time of pre-operative exam
- Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
- Demonstration of refractive stability
- Anticipated post-operative stromal bed thickness of at lest 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 Mixed Astigmatic Refractive Errors With the iDESIGN Advanced Wavescan Studio™ System and STAR S4 IR™ Excimer Laser System
To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.
- Conditions
- Astigmatism
- Being tested
- LASIK
- Keywords
- Astigmatism, refractive, error, LASIK
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASIKDevice
Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System
| Study group | Role | What they receive |
|---|---|---|
| wave-front guided LASIK | Experimental | Not described Receives: Device: LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA)
< 5% of eyes will have a loss of > 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters
Measured: 3 Months
Secondary outcomes (1)
Uncorrected Visual Acuity (UCVA) of 20/40 or Better
85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study start6 Dec 2012
- Primary completion22 Nov 2016
- Study completion22 Nov 2016
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 AstigmatismStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 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
- NCT01675492
- Sponsor's protocol ID
- STAR-112-IDMA
- Status last verified
- Jan 2025
- First submitted
- 28 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 Mixed Astigmatic Refractive Errors With the iDESIGN Advanced Wavescan Studio™ System and STAR S4 IR™ Excimer Laser System
- ClinicalTrials.gov ID
- NCT01675492
- Acronym / sponsor ID
- STAR-112-IDMA
- Conditions
- Astigmatism
- Keywords
- Astigmatism, refractive, error, LASIK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Abbott Medical OpticsIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2012 (actual)
- Primary completion
- 22 Nov 2016 (actual)
- Study completion
- 22 Nov 2016 (actual)
- First posted
- 30 Aug 2012 (estimated)
- Results
- Posted 30 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| wave-front guided LASIK | Experimental | Device: LASIK |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age at the time of pre-operative exam
- Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
- Demonstration of refractive stability
- Anticipated post-operative stromal bed thickness of at lest 250 microns
- Willing and capable of returning for follow-up examinations for the duration of the study
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 |
|---|---|---|
| LASIKSurgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System | Device | wave-front guided LASIK |
Primary outcome
Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA)
Time frame: 3 Months
< 5% of eyes will have a loss of > 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters
1 secondary outcome
Uncorrected Visual Acuity (UCVA) of 20/40 or Better
Time frame: 3 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 study testing LASIK in people with Astigmatism, 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 5 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2017). 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?
Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA) (time frame: 3 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.