MyopiaNCT00714922
Comparison of Photorefractive Keratectomy (PRK) and Sub-Bowman's Keratomileusis (SBK)
A study testing PRK and SBK in people with Myopia, run by University of Utah at 1 site in United States.
Trial summary
The objective of the study is to compare clinical outcomes from PRK and SBK using FDA-approved laser technology in the same patient Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Myopia
- What is being tested?
- PRK and SBK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Sep 2010
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients deemed to be suitable candidates for bilateral LASIK surgery
Who cannot join
- Patients who desire monovision correction rather than bilateral distance correction
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah, John Moran Eye Center
Salt Lake City, Utah, 84106
About this study
Official title: Comparison of Photorefractive Keratectomy (PRK) and Sub-Bowman's Keratomileusis (SBK): Assessment of Visual Function and Patient Satisfaction
The objective of the study is to compare clinical outcomes from PRK and SBK using FDA-approved laser technology in the same patient
Read the detailed description
Patients undergoing bilateral laser refractive surgery on the same day will be randomly assigned to have one eye treated with PRK and the fellow eye treated with SBK.
- Conditions
- Myopia
- Being tested
- PRK, SBK
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRKProcedure or surgery
Laser refractive surgery
SBKProcedure or surgery
Laser refractive surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | PRK Receives: Procedure: PRK |
| 2 | Active comparator | SBK Receives: Procedure: SBK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: 6 months
Secondary outcomes (2)
Manifest refraction
Measured: 6 months
Wavefront aberration value
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 posted14 Jul 2008 (estimated)
- Study startOct 2007
- Primary completionSep 2010
- Study completionSep 2010
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.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Investigators
- Majid Moshirfar, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714922
- Sponsor's protocol ID
- 25516
- Status last verified
- Sep 2010
- First submitted
- 8 Jul 2008
- Last updated
- 16 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Photorefractive Keratectomy (PRK) and Sub-Bowman's Keratomileusis (SBK): Assessment of Visual Function and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT00714922
- Acronym / sponsor ID
- 25516
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 14 Jul 2008 (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.
The objective of the study is to compare clinical outcomes from PRK and SBK using FDA-approved laser technology in the same patient
Detailed description
Patients undergoing bilateral laser refractive surgery on the same day will be randomly assigned to have one eye treated with PRK and the fellow eye treated with SBK.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: PRKPRK |
| 2 | Active comparator | Procedure: SBKSBK |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients deemed to be suitable candidates for bilateral LASIK surgery
Key exclusion criteria (1 listed)
- Patients who desire monovision correction rather than bilateral distance correction
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 |
|---|---|---|
| PRKLaser refractive surgery | Procedure or surgery | 1 |
| SBKLaser refractive surgery | Procedure or surgery | 2 |
Primary outcome
Visual acuity
Time frame: 6 months
2 secondary outcomes
Manifest refraction
Time frame: 6 months
Wavefront aberration value
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2010.
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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.
Majid Moshirfar, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRK and SBK in people with Myopia, run by University of Utah at 1 site in United States.
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 1 inclusion and 1 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 16 Sep 2010. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 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 16 Sep 2010.