Refractive ErrorsNCT00365040
Customized PRK With Mitomycin Versus Customized Lasik for Myopic Astigmatism
A study testing Prk with mitomycin vs Lasik in people with Refractive Errors, run by Federal University of São Paulo.
Trial summary
The present study was designed to compare the use of mitomycin in PRK for the treatment of refractive errors and to compare these results to customized Lasik Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors
- What is being tested?
- Prk with mitomycin vs Lasik
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Oct 2006
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Myopia or compound myopic astigmatism, stable refractive error, no associated eye disease
Who cannot join
- Diabetes, autoimmune diseases, topographic abnormalities
About this study
The present study was designed to compare the use of mitomycin in PRK for the treatment of refractive errors and to compare these results to customized Lasik
- Conditions
- Refractive Errors
- Being tested
- Prk with mitomycin vs Lasik
- Keywords
- myopia, excimer laser
- Medical subject headings
- Refractive Errors, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prk with mitomycin vs LasikProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
refractive errors
topography patterns
aberrometry data
Secondary outcomes (1)
subjective evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startDec 2004
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Mauro Campos, MD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365040
- Sponsor's protocol ID
- AWMC
- Status last verified
- Jul 2006
- First submitted
- 15 Aug 2006
- Last updated
- 17 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customized PRK With Mitomycin Versus Customized Lasik for Myopic Astigmatism
- ClinicalTrials.gov ID
- NCT00365040
- Acronym / sponsor ID
- AWMC
- Conditions
- Refractive Errors
- Keywords
- myopia, excimer laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Dec 2004
- Study completion
- Oct 2006
- First posted
- 17 Aug 2006 (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 present study was designed to compare the use of mitomycin in PRK for the treatment of refractive errors and to compare these results to customized Lasik
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Myopia or compound myopic astigmatism, stable refractive error, no associated eye disease
Key exclusion criteria (1 listed)
- Diabetes, autoimmune diseases, topographic abnormalities
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 |
|---|---|---|
| Prk with mitomycin vs Lasik | Procedure or surgery | – |
Primary outcome
visual acuity
refractive errors
topography patterns
aberrometry data
1 secondary outcome
subjective evaluation
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 17 Aug 2006.
Related trials for Refractive Errors
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Children's Viewing Behavior
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The EYERISING Study
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A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
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Clareon TruPlus Study
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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.
Mauro Campos, MD study chair
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Prk with mitomycin vs Lasik in people with Refractive Errors, run by Federal University of São Paulo.
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 17 Aug 2006. 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?
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. The study lists 4 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 17 Aug 2006.