Stable Myopic Refractive Error, With or Without AstigmatismNCT02675751
Prospective S&E Study of Wavefront-guided PRK for Myopia With iDesign Advanced Wavescan Studio™ System and Star S4 IR™
A study testing STAR S4 IR laser with iDesign in people with Stable Myopic Refractive Error, With or Without Astigmatism, run by Abbott Medical Optics.
Trial summary
Prospective, multicenter, bilaterally-treated, open-label, non-randomized clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Myopic Refractive Error, With or Without Astigmatism
- What is being tested?
- STAR S4 IR laser with iDesign
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- No sites listed yet
- Study dates
- 3 Feb 2016to 27 Jul 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent and HIPAA authorization.
- Refractive error, based on the iDesign displayed refraction must be myopia with or without astigmatism with sphere up to -8.00 D, and cylinder between 0.00 D and -4.00 D with maximum SE of -10.00 D.
- Anticipated residual stromal bed thickness of at least 250 microns as calculated by the iDesign system.
- Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
- BSCVA ≥2 lines (≥10 letters) better than distance Uncorrected Visual Acuity (UCVA).
- Less than or equal to 0.75 D difference between cycloplegic and manifest refraction sphere.
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- Stable refractive error as defined by a change of ≤1.00 D in MRSE over at least a 12 month time period.
- Any subject eye with a history of contact lens wear within the last 4 weeks must demonstrate refractive stability
- Agreement between manifest refraction (adjusted for optical infinity) and iDesign System refraction chosen for treatment.
- Willing and capable of complying with follow-up examinations for the duration of the study.
Who cannot join
- Women who are pregnant, breast-feeding, or intend to become pregnant, or not using an adequate method of birth control.
- Concurrent use of systemic (including inhaled) medications that may impair healing.
- History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
- Subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device.
- History of prior intraocular or corneal surgery, active ophthalmic disease or abnormality, retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm and visible on topography, at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma.
- Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal topography
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- Known sensitivity or inappropriate responsiveness to any of the medications used in this study.
- If either eye does not meet all inclusion criteria
- Desire to have monovision.
- Participation in any other clinical study, with the exception of the fellow eye in this study.
About this study
Official title: A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-guided PRK Correction of Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and the Star S4 IR™ Excimer Laser System
Prospective, multicenter, bilaterally-treated, open-label, non-randomized clinical trial.
- Being tested
- STAR S4 IR laser with iDesign
- Keywords
- myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR S4 IR laser with iDesignDevice
Surgeons will perform wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser.
| Study group | Role | What they receive |
|---|---|---|
| wavefront-guided PRK with iDesign | Experimental | wavefront-guided PRK for treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser Receives: Device: STAR S4 IR laser with iDesign |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Eyes Achieving the Target of Monocular Uncorrected Visual Acuity of 20/40 or Better
At 6 months, UCVA of 20/40 was achieved in 100% (324/324) of eyes monocularly.
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 posted5 Feb 2016 (estimated)
- Study start3 Feb 2016
- Primary completion27 Jul 2018
- Study completion27 Jul 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stable Myopic Refractive Error, With or Without 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
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Optics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Surgical Vision Clinical Trials, Study director, Johnson & Johnson Surgical Vision, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675751
- Sponsor's protocol ID
- STAR-115-MIPS
- Status last verified
- Jan 2025
- First submitted
- 3 Feb 2016
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Hofmeister EM, Cason JB, Murdoch DM, Yau IW, Wang Y, Parizadeh DD, Janakiraman DP, Kasthurirangan S. Wavefront-guided PRK treatment of myopia using a refractive aberrometer. J Cataract Refract Surg. 2023 Mar 1;49(3):292-298. doi: 10.1097/j.jcrs.0000000000001083.
PubMed 36730946
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 PRK Correction of Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and the Star S4 IR™ Excimer Laser System
- ClinicalTrials.gov ID
- NCT02675751
- Acronym / sponsor ID
- STAR-115-MIPS
- Keywords
- myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Abbott Medical OpticsIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2016 (actual)
- Primary completion
- 27 Jul 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Posted 24 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multicenter, bilaterally-treated, open-label, non-randomized clinical trial.
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 PRK with iDesign | Experimental | Device: STAR S4 IR laser with iDesignwavefront-guided PRK for treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent and HIPAA authorization.
- Refractive error, based on the iDesign displayed refraction must be myopia with or without astigmatism with sphere up to -8.00 D, and cylinder between 0.00 D and -4.00 D with maximum SE of -10.00 D.
- Anticipated residual stromal bed thickness of at least 250 microns as calculated by the iDesign system.
- Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
- BSCVA ≥2 lines (≥10 letters) better than distance Uncorrected Visual Acuity (UCVA).
Key exclusion criteria (10 listed)
- Women who are pregnant, breast-feeding, or intend to become pregnant, or not using an adequate method of birth control.
- Concurrent use of systemic (including inhaled) medications that may impair healing.
- History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
- Subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device.
- History of prior intraocular or corneal surgery, active ophthalmic disease or abnormality, retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm and visible on topography, at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma.
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 |
|---|---|---|
| STAR S4 IR laser with iDesignSurgeons will perform wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser. | Device | wavefront-guided PRK with iDesign |
Primary outcome
The Percentage of Eyes Achieving the Target of Monocular Uncorrected Visual Acuity of 20/40 or Better
Time frame: 6 months
At 6 months, UCVA of 20/40 was achieved in 100% (324/324) of eyes monocularly.
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.
- Derived from this study: PubMed 36730946Hofmeister EM, Cason JB, Murdoch DM, Yau IW, Wang Y, Parizadeh DD, Janakiraman DP, Kasthurirangan S. Wavefront-guided PRK treatment of myopia using a refractive aberrometer. J Cataract Refract Surg. 2023 Mar 1;49(3):292-298. doi: 10.1097/j.jcrs.0000000000001083.
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.
Johnson & Johnson Surgical Vision Clinical Trials study director
Johnson & Johnson Surgical Vision, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing STAR S4 IR laser with iDesign in people with Stable Myopic Refractive Error, With or Without 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 10 inclusion and 10 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 24 Sep 2019). 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?
The Percentage of Eyes Achieving the Target of Monocular Uncorrected Visual Acuity of 20/40 or Better (time frame: 6 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 NCT02675751, 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 4 Feb 2025.