MyopiaPhase 4NCT00404105
A Comparison of PRK and LASIK for Correction of Myopia
A Phase 4 study testing PRK and LASIK in people with Myopia, run by University of Aarhus at 1 site in Denmark.
Trial summary
The study compares the precision and accuracy of two laser refractive techniques, PRK and LASIK, for correction of nearsightedness between -6 and -8 diopters. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Myopia
- What is being tested?
- PRK and LASIK
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2000to May 2004
- Phase
- Phase 4
- 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 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- spherical equivalent subjective refraction between -6.00 and -8.00 diopters
- age between 18 and 49 years
- desire for having laser refractive surgery
Who cannot join
- present or past eye disease excluding myopia
- pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomised Trial of Photo-Refractive Keratectomy (PRK) and Laser-in-Situ-Keratomileusis (LASIK) for Correction of Myopia
The study compares the precision and accuracy of two laser refractive techniques, PRK and LASIK, for correction of nearsightedness between -6 and -8 diopters.
- Conditions
- Myopia
- Being tested
- PRK, LASIK
- Keywords
- Excimer laser
- 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
LASIKProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected visual acuity
Best corrected visual acuity
Best spectacle correction
Secondary outcomes (3)
IOP
Corneal thickness
Corneal wavefront aberrations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2006 (estimated)
- Study startJun 2000
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Jesper Hjortdal, MD, PhD, Principal investigator, Department of Ophthalmology, Aarhus Sygehus, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404105
- Sponsor's protocol ID
- AUH-Ophthalmology-1999-01
- Status last verified
- Nov 2006
- First submitted
- 24 Nov 2006
- Last updated
- 27 Nov 2006
- Results posted
- No
Publications
Ivarsen A, Hjortdal J. Seven-year changes in corneal power and aberrations after PRK or LASIK. Invest Ophthalmol Vis Sci. 2012 Sep 6;53(10):6011-6. doi: 10.1167/iovs.12-10208.
PubMed 22879417
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised Trial of Photo-Refractive Keratectomy (PRK) and Laser-in-Situ-Keratomileusis (LASIK) for Correction of Myopia
- ClinicalTrials.gov ID
- NCT00404105
- Acronym / sponsor ID
- AUH-Ophthalmology-1999-01
- Conditions
- Myopia
- Keywords
- Excimer laser
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jun 2000
- Study completion
- May 2004
- First posted
- 27 Nov 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 study compares the precision and accuracy of two laser refractive techniques, PRK and LASIK, for correction of nearsightedness between -6 and -8 diopters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- spherical equivalent subjective refraction between -6.00 and -8.00 diopters
- age between 18 and 49 years
- desire for having laser refractive surgery
Key exclusion criteria (2 listed)
- present or past eye disease excluding myopia
- pregnant or lactating woman
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 | Procedure or surgery | – |
| LASIK | Procedure or surgery | – |
Primary outcome
Uncorrected visual acuity
Best corrected visual acuity
Best spectacle correction
3 secondary outcomes
IOP
Corneal thickness
Corneal wavefront aberrations
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 27 Nov 2006.
- Derived from this study: PubMed 22879417Ivarsen A, Hjortdal J. Seven-year changes in corneal power and aberrations after PRK or LASIK. Invest Ophthalmol Vis Sci. 2012 Sep 6;53(10):6011-6. doi: 10.1167/iovs.12-10208.
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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.
Jesper Hjortdal, MD, PhD principal investigator
Department of Ophthalmology, Aarhus Sygehus, University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PRK and LASIK in people with Myopia, run by University of Aarhus at 1 site in Denmark.
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 2 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 27 Nov 2006. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Uncorrected visual acuity. The study lists 3 primary outcomes in all. 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 NCT00404105, 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 27 Nov 2006.