MyopiaNCT00366574
Comparison of a Laser Keratome to a Mechanical Microkeratome
A study testing Amadeus Microkeratome and IntraLase in people with Myopia and Astigmatism, run by Medical University of South Carolina.
Trial summary
The purpose of this study was to evaluate the performance of the INTRALASE®, a laser keratome which creates a corneal flap, and compare it to a mechanical microkeratome (Amadeus™). Our hypothesis is that there is no difference between the 2 devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia, Astigmatism, Myopic Astigmatism
- What is being tested?
- Amadeus Microkeratome and IntraLase
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Feb 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidate for bilateral wavefront-guided LASIK
- Myopia up to -7.00 D
- Astigmatism of 0.00 to -1.50 D
Who cannot join
- History of ocular pathology
- Previous ocular surgery
- Very large pupils (greater than 8mm diameter, infrared measurement)
- Thin corneas (preoperatively calculated minimal residual bed < 250 um)
- Irregular astigmatism
- Asymmetric astigmatism
- Unstable refraction
- Any other criteria that precludes subject to undergo LASIK
About this study
Official title: Comparison of INTRALASE® to AMADEUS™ Microkeratome
The purpose of this study was to evaluate the performance of the INTRALASE®, a laser keratome which creates a corneal flap, and compare it to a mechanical microkeratome (Amadeus™). Our hypothesis is that there is no difference between the 2 devices.
- Conditions
- Myopia, Astigmatism, Myopic Astigmatism
- Being tested
- Amadeus Microkeratome, IntraLase
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amadeus MicrokeratomeDevice
IntraLaseDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Contrast sensitivity
Induction of high order aberration
Corneal sensation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study startSep 2004
- Study completionFeb 2005
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 Medical University of South CarolinaThe 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
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Investigators
- Kerry D. Solomon, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366574
- Sponsor's protocol ID
- MRC-05-003
- Status last verified
- Mar 2005
- First submitted
- 17 Aug 2006
- Last updated
- 21 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of INTRALASE® to AMADEUS™ Microkeratome
- ClinicalTrials.gov ID
- NCT00366574
- Acronym / sponsor ID
- MRC-05-003
- Conditions
- Myopia, Astigmatism, Myopic Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Feb 2005
- First posted
- 21 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 purpose of this study was to evaluate the performance of the INTRALASE®, a laser keratome which creates a corneal flap, and compare it to a mechanical microkeratome (Amadeus™). Our hypothesis is that there is no difference between the 2 devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Candidate for bilateral wavefront-guided LASIK
- Myopia up to -7.00 D
- Astigmatism of 0.00 to -1.50 D
Key exclusion criteria (8 listed)
- History of ocular pathology
- Previous ocular surgery
- Very large pupils (greater than 8mm diameter, infrared measurement)
- Thin corneas (preoperatively calculated minimal residual bed < 250 um)
- Irregular astigmatism
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 |
|---|---|---|
| Amadeus Microkeratome | Device | – |
| IntraLase | Device | – |
Primary outcome
Visual acuity
Contrast sensitivity
Induction of high order aberration
Corneal sensation
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 21 Aug 2006.
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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.
Kerry D. Solomon, MD principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing Amadeus Microkeratome and IntraLase in people with Myopia and Astigmatism, run by Medical University of South Carolina.
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 3 inclusion and 8 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 21 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 21 Aug 2006.