Lasik Eye SurgeryLASIKNCT01695642
Long-term LASIK Follow up Study
An observational study of Lasik Eye Surgery, run by University of Michigan at 1 site in United States.
Trial summary
Laser in situ keratomileusis (LASIK) is the most common corneal refractive surgery performed for correction of myopia. There are very few studies that have been performed to evaluate long-term outcomes after LASIK. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lasik Eye Surgery
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Dec 2016
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects who had LASIK surgery for correction of myopia or myopic astigmatism at the Kellogg Eye Center with either the microkeratome or femtosecond laser for LASIK flap creation between 2002 to 2005.
Who may be able to join
- lasik surgery at the kellogg eye center between 2002 and 2005; at least 3 months of follow up after surgery
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Outcomes After Laser in Situ Keratomileusis (LASIK): Mechanical Microkeratome vs Femtosecond Laser
Laser in situ keratomileusis (LASIK) is the most common corneal refractive surgery performed for correction of myopia. There are very few studies that have been performed to evaluate long-term outcomes after LASIK.
In this study, we will assess long-term outcomes 5 - 10 years after LASIK to assess stability of visual outcomes and long-term effect on corneal morphology with in vivo confocal microscopy. Clinical and corneal morphology outcomes will also be compared between patients who had flaps created with the microkeratome and femtosecond laser.
Read the detailed description
Volunteers will be eligible for enrollment into the study if have had LASIK surgery for correction of myopia or myopic astigmatism at the Kellogg Eye Center with either the microkeratome or femtosecond laser for LASIK flap creation between 5 and 10 years prior.
A complete ophthalmic examination and corneal confocal microscopy will be performed. The study visit will take approximately one hour.
- Conditions
- Lasik Eye Surgery
- Keywords
- lasik, intralase, microkeratome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Microkeratome | mechanical microkeratome | |
| Intralase | femtosecond laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare flap creation with mikrokeratome and Intralase
Measured: 8 to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startJun 2011
- Primary completionDec 2013
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lasik Eye SurgeryStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roni Shtein, University of Michigan
- Investigators
- Roni Shtein, MD, MS, Principal investigator, University of Michigan Kellogg Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695642
- Sponsor's protocol ID
- LASIK_00049051
- Acronym
- LASIK
- Status last verified
- Mar 2017
- First submitted
- 26 Sep 2012
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes After Laser in Situ Keratomileusis (LASIK): Mechanical Microkeratome vs Femtosecond Laser
- ClinicalTrials.gov ID
- NCT01695642
- Acronym / sponsor ID
- LASIK / LASIK_00049051
- Conditions
- Lasik Eye Surgery
- Keywords
- lasik, intralase, microkeratome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Sep 2012 (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.
Laser in situ keratomileusis (LASIK) is the most common corneal refractive surgery performed for correction of myopia. There are very few studies that have been performed to evaluate long-term outcomes after LASIK.
In this study, we will assess long-term outcomes 5 - 10 years after LASIK to assess stability of visual outcomes and long-term effect on corneal morphology with in vivo confocal microscopy. Clinical and corneal morphology outcomes will also be compared between patients who had flaps created with the microkeratome and femtosecond laser.
Detailed description
Volunteers will be eligible for enrollment into the study if have had LASIK surgery for correction of myopia or myopic astigmatism at the Kellogg Eye Center with either the microkeratome or femtosecond laser for LASIK flap creation between 5 and 10 years prior.
A complete ophthalmic examination and corneal confocal microscopy will be performed. The study visit will take approximately one hour.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microkeratome | – | –mechanical microkeratome |
| Intralase | – | –femtosecond laser |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects who had LASIK surgery for correction of myopia or myopic astigmatism at the Kellogg Eye Center with either the microkeratome or femtosecond laser for LASIK flap creation between 2002 to 2005.
Key inclusion criteria (1 listed)
- lasik surgery at the kellogg eye center between 2002 and 2005; at least 3 months of follow up after surgery
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare flap creation with mikrokeratome and Intralase
Time frame: 8 to 10 years
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 20 Mar 2017.
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SMILE Surgery in One Eye Compared to Ray Tracing-guided LASIK Surgery in the Fellow Eye
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A Study to Assess Brillouin Hydration Mapping for the Evaluation of Ocular Tissues and Diseases
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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.
Roni Shtein, MD, MS principal investigator
University of Michigan Kellogg Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lasik Eye Surgery, run by University of Michigan 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 0 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 20 Mar 2017. 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?
Compare flap creation with mikrokeratome and Intralase (time frame: 8 to 10 years). 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 20 Mar 2017.