MyopiaNCT01988415
New Treatment Algorithm to Reduce Spherical Aberration After LASIK Correction for Myopia
A study testing VSS-Rx1 OPM vs Commercial iDesign Treatment in people with Myopia and Astigmatism, run by Abbott Medical Optics at 1 site in Colombia.
Trial summary
The purpose of this clinical trial is to demonstrate that treatments generated by an investigational algorithm reduces spherical aberration compared to currently available iDesign treatments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- VSS-Rx1 OPM vs Commercial iDesign Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteColombia
- Study dates
- Nov 2013to Jul 2014
- 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
- Male or female at least 18 years of age at the time of preoperative exam
- Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
- Demonstration of refractive stability
- Anticipated postoperative stromal bed thickness of at least 250 microns
- Willing and able to return for all study examinations
Who cannot join
- 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 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 postoperative course
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study to Evaluate the Feasibility of a New Treatment Algorithm for Wavefront-Guided Lasik Correction of Myopic Refractive Errors
The purpose of this clinical trial is to demonstrate that treatments generated by an investigational algorithm reduces spherical aberration compared to currently available iDesign treatments.
Read the detailed description
Post-LASIK induction of spherical aberration is currently among the most prominent challenges for refractive surgery. The presence of significant spherical aberration in the visual system results in reduced contrast sensitivity, visual symptoms such as "glare" and "halos," and "night myopia" or the induction of myopia under low lighting (larger pupil size). A modified Treatment Planning Software (TPS) "VSS-Rx1 OPM software" has been developed that uses a modified algorithm (software that designs the LASIK treatment profile) to limit the induction of postoperative spherical aberration. Commercially available software used to calculate the LASIK treatment profile was used in one eye (active comparator [i.e., control]) and VSS-Rx1 OPM software was used in the fellow eye (experimental). Subjects were masked to the use of either the commercially available or VSS-Rx1 OPM software.
- Conditions
- Myopia, Astigmatism
- Being tested
- VSS-Rx1 OPM vs Commercial iDesign Treatment
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSS-Rx1 OPM vs Commercial iDesign TreatmentDevice
Commercially available iDesign treatment planning software used to calculate the LASIK treatment profile vs VSS-Rx1 OPM (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration).
| Study group | Role | What they receive |
|---|---|---|
| VSS-Rx1 OPM vs Commercial iDesign Treatment | Other | Commercially available iDesign treatment planning software used to calculate the LASIK treatment profile in one eye (active comparator [i.e., control]) and investigational software (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration) in the fellow eye (experimental). Receives: Device: VSS-Rx1 OPM vs Commercial iDesign Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Postoperative Spherical Aberration
Primary Efficacy Outcome Measure: mean spherical aberration of eyes treated with the VSS-Rx1 OPM treatment planning software compared to that of eyes treated with the commercial iDesign treatment planning software.
Measured: 3 months
Percentage of Eyes Losing More Than 2 Lines of Best-corrected Distance Visual Acuity
Primary Safety Outcome Measure: percentage of eyes losing more than 2 lines of best-corrected distance visual acuity
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 posted20 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2014
- Study completionJul 2014
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Optics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gustavo Tamayo, M.D., Principal investigator, Medico Oftalmologo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988415
- Sponsor's protocol ID
- STAR-114-SARA
- Status last verified
- Jan 2016
- First submitted
- 14 Nov 2013
- Last updated
- 5 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Feasibility of a New Treatment Algorithm for Wavefront-Guided Lasik Correction of Myopic Refractive Errors
- ClinicalTrials.gov ID
- NCT01988415
- Acronym / sponsor ID
- STAR-114-SARA
- Conditions
- Myopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Abbott Medical OpticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Posted 5 Feb 2016
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 treatments generated by an investigational algorithm reduces spherical aberration compared to currently available iDesign treatments.
Detailed description
Post-LASIK induction of spherical aberration is currently among the most prominent challenges for refractive surgery. The presence of significant spherical aberration in the visual system results in reduced contrast sensitivity, visual symptoms such as "glare" and "halos," and "night myopia" or the induction of myopia under low lighting (larger pupil size). A modified Treatment Planning Software (TPS) "VSS-Rx1 OPM software" has been developed that uses a modified algorithm (software that designs the LASIK treatment profile) to limit the induction of postoperative spherical aberration. Commercially available software used to calculate the LASIK treatment profile was used in one eye (active comparator [i.e., control]) and VSS-Rx1 OPM software was used in the fellow eye (experimental). Subjects were masked to the use of either the commercially available or VSS-Rx1 OPM software.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VSS-Rx1 OPM vs Commercial iDesign Treatment | Other | Device: VSS-Rx1 OPM vs Commercial iDesign TreatmentCommercially available iDesign treatment planning software used to calculate the LASIK treatment profile in one eye (active comparator [i.e., control]) and investigational software (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration) in the fellow eye (experimental). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female at least 18 years of age at the time of preoperative exam
- Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
- Demonstration of refractive stability
- Anticipated postoperative stromal bed thickness of at least 250 microns
- Willing and able to return for all study examinations
Key exclusion criteria (5 listed)
- 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 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 postoperative course
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 |
|---|---|---|
| VSS-Rx1 OPM vs Commercial iDesign TreatmentCommercially available iDesign treatment planning software used to calculate the LASIK treatment profile vs VSS-Rx1 OPM (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration). | Device | VSS-Rx1 OPM vs Commercial iDesign Treatment |
Primary outcome
Mean Postoperative Spherical Aberration
Time frame: 3 months
Primary Efficacy Outcome Measure: mean spherical aberration of eyes treated with the VSS-Rx1 OPM treatment planning software compared to that of eyes treated with the commercial iDesign treatment planning software.
Percentage of Eyes Losing More Than 2 Lines of Best-corrected Distance Visual Acuity
Time frame: 3 Months
Primary Safety Outcome Measure: percentage of eyes losing more than 2 lines of best-corrected distance visual acuity
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
- 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.
Gustavo Tamayo, M.D. principal investigator
Medico Oftalmologo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VSS-Rx1 OPM vs Commercial iDesign Treatment in people with Myopia and Astigmatism, run by Abbott Medical Optics at 1 site in Colombia.
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 5 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 5 Feb 2016. 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 Colombia. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2016). 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?
Mean Postoperative Spherical Aberration (time frame: 3 months). The study lists 2 primary outcomes in all. 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 5 Feb 2016.