MyopiaNCT01138189
Wavefront-guided Versus Wavefront-optimized LASIK for Nearsightedness
An observational study of Myopia and Astigmatism, run by Edward E. Manche at 1 site in United States.
Trial summary
The purpose of the study is to compare the results of LASIK surgery when using wavefront-guided excimer laser treatment compared to wavefront optimized excimer laser treatment in patients with nearsightedness with and without astigmatism Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- Wavefront-guided LASIK and Wavefront-optimized LASIK
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2010to 30 Apr 2012
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects age 21 and older with healthy eyes. Nearsightedness between -7.50 diopters and -7.00 diopters with or without astigmatism of up to 3.50 diopters.
Who may be able to join
- Subjects age 21 and older with healthy eyes.
- Nearsightedness between -7.50 diopters and -7.00 diopters with or without astigmatism of up to 3.50 diopters.
Who cannot join
- Subjects under the age of 21.
- Patients with excessively thin corneas.
- Patients with topographic evidence of keratoconus.
- Patients with autoimmune diseases.
- Patients who are pregnant or nursing.
- Patients must have similar levels of nearsightedness in each eye. They can not be more than 3.0 diopter of difference between eyes.
- Patients must have similar levels of astigmatism in each eye. They can not have more than 4.0 diopters of difference in nearsightedness or astigmatism between their two eyes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Prospective Eye to Eye Comparison of LASIK Using Wavefront-guided Treatment Versus Wavefront-optimized Treatment
The purpose of the study is to compare the results of LASIK surgery when using wavefront-guided excimer laser treatment compared to wavefront optimized excimer laser treatment in patients with nearsightedness with and without astigmatism
Read the detailed description
This is a research study comparing the outcomes of LASIK surgery for nearsightedness when using the two different excimer laser technologies. Patients will have both eyes treated with the Alcon WaveLight Allegretto excimer laser. You will be one of 150 sighted patients at Stanford to undergo treatment in this clinical research trial. This will be a prospective, randomized, research study in which up to 300 consecutive eyes scheduled to undergo excimer laser in situ keratomileusis (LASIK) using one laser technology in the first eye and the second laser technology in the fellow eye for the correction of myopia (nearsightedness) with or without astigmatism will be enrolled. The choice of which eye receives the wavefront guided technology and which eye receives the wavefront-optimized technology will be randomized prior to enrollment. Randomization will be done according to a randomization schedule. You will know which eye is being treated with which each technology. The randomization will determine only whether your right or left eye is treated with the wavefront guided technology. The other eye will be treated with wavefront-optimized laser technology. You have a fifty percent chance of having your left eye treated with custom wavefront guided technology as your right eye. Subjects will undergo bilateral (both eyes at once) LASIK treatments using the Alcon WaveLight Allegretto excimer laser. All subjects will be followed for one year after the vision correction procedure. Subjects scheduled to undergo LASIK for the correction of myopia (nearsightedness) with or without astigmatism will be screened for eligibility. Eligible subjects will be examined preoperatively to establish a baseline for ocular condition (the general health and glasses prescription of the eyes). Postoperatively, subjects will undergo an ophthalmic evaluation (complete eye examination) at regular intervals as specified in this protocol. Retreatments (a second operation on the same eye for residual nearsightedness) will not be allowed during the first twelve months of this study. If you elect to undergo a retreatment of your LASIK surgery prior to the 12-month post-operative visit, the retreated eye will be exited from the study as of the retreatment date.
Any significant new finding developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject or subject's representative in a timely manner.
- Conditions
- Myopia, Astigmatism
- Being tested
- Wavefront-guided LASIK, Wavefront-optimized LASIK
- Keywords
- Wavefront-guided LASIK., Wavefront-optimized LASIK., Custom LASIK
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wavefront-guided LASIKProcedure or surgery
Also called Wavelight Allegretto Eye-Q 400 Hz excimer laser
Wavefront-guided LASIK in one eye using the Allegretto excimer laser
Wavefront-optimized LASIKProcedure or surgery
Also called Wavelight Allegretto Eye-Q 400 Hz excimer laser
Wavefront-optimized LASIK in one eye using the Allegretto excimer laser
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in best corrected visual acuity
Measured: 12 months
Changes in 5 and 25% contrast visual acuity
Measured: 12 months
Refractive predictability
Measured: 12 months
Uncorrected visual acuity
Measured: 12 months
Secondary outcomes (3)
Changes in higher order aberrations
Measured: 1 yr
Quality of vision measurement
Measured: 1 yr
Topographic analysis
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study start6 Apr 2010
- Primary completion30 Apr 2012
- Study completion30 Apr 2012
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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward E. Manche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edward E. Manche, Stanford University
- Investigators
- Edward E. Manche, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138189
- Sponsor's protocol ID
- SU-05272010-6188
- Other IDs
- Stanford Protocol # 18692
- Status last verified
- Nov 2021
- First submitted
- 3 Jun 2010
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Sales CS, Manche EE. One-year outcomes from a prospective, randomized, eye-to-eye comparison of wavefront-guided and wavefront-optimized LASIK in myopes. Ophthalmology. 2013 Dec;120(12):2396-2402. doi: 10.1016/j.ophtha.2013.05.010. Epub 2013 Jun 15.
PubMed 23778091
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Eye to Eye Comparison of LASIK Using Wavefront-guided Treatment Versus Wavefront-optimized Treatment
- ClinicalTrials.gov ID
- NCT01138189
- Acronym / sponsor ID
- SU-05272010-6188
- Conditions
- Myopia, Astigmatism
- Keywords
- Wavefront-guided LASIK., Wavefront-optimized LASIK., Custom LASIK
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Edward E. MancheUniversity, hospital or other
- Study start
- 6 Apr 2010 (actual)
- Primary completion
- 30 Apr 2012 (actual)
- Study completion
- 30 Apr 2012 (actual)
- First posted
- 7 Jun 2010 (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 the study is to compare the results of LASIK surgery when using wavefront-guided excimer laser treatment compared to wavefront optimized excimer laser treatment in patients with nearsightedness with and without astigmatism
Detailed description
This is a research study comparing the outcomes of LASIK surgery for nearsightedness when using the two different excimer laser technologies. Patients will have both eyes treated with the Alcon WaveLight Allegretto excimer laser. You will be one of 150 sighted patients at Stanford to undergo treatment in this clinical research trial. This will be a prospective, randomized, research study in which up to 300 consecutive eyes scheduled to undergo excimer laser in situ keratomileusis (LASIK) using one laser technology in the first eye and the second laser technology in the fellow eye for the correction of myopia (nearsightedness) with or without astigmatism will be enrolled. The choice of which eye receives the wavefront guided technology and which eye receives the wavefront-optimized technology will be randomized prior to enrollment. Randomization will be done according to a randomization schedule. You will know which eye is being treated with which each technology. The randomization will determine only whether your right or left eye is treated with the wavefront guided technology. The other eye will be treated with wavefront-optimized laser technology. You have a fifty percent chance of having your left eye treated with custom wavefront guided technology as your right eye. Subjects will undergo bilateral (both eyes at once) LASIK treatments using the Alcon WaveLight Allegretto excimer laser. All subjects will be followed for one year after the vision correction procedure. Subjects scheduled to undergo LASIK for the correction of myopia (nearsightedness) with or without astigmatism will be screened for eligibility. Eligible subjects will be examined preoperatively to establish a baseline for ocular condition (the general health and glasses prescription of the eyes). Postoperatively, subjects will undergo an ophthalmic evaluation (complete eye examination) at regular intervals as specified in this protocol. Retreatments (a second operation on the same eye for residual nearsightedness) will not be allowed during the first twelve months of this study. If you elect to undergo a retreatment of your LASIK surgery prior to the 12-month post-operative visit, the retreated eye will be exited from the study as of the retreatment date.
Any significant new finding developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject or subject's representative in a timely manner.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects age 21 and older with healthy eyes. Nearsightedness between -7.50 diopters and -7.00 diopters with or without astigmatism of up to 3.50 diopters.
Key inclusion criteria (2 listed)
- Subjects age 21 and older with healthy eyes.
- Nearsightedness between -7.50 diopters and -7.00 diopters with or without astigmatism of up to 3.50 diopters.
Key exclusion criteria (7 listed)
- Subjects under the age of 21.
- Patients with excessively thin corneas.
- Patients with topographic evidence of keratoconus.
- Patients with autoimmune diseases.
- Patients who are pregnant or nursing.
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 |
|---|---|---|
| Wavefront-guided LASIKAlso: Wavelight Allegretto Eye-Q 400 Hz excimer laserWavefront-guided LASIK in one eye using the Allegretto excimer laser | Procedure or surgery | – |
| Wavefront-optimized LASIKAlso: Wavelight Allegretto Eye-Q 400 Hz excimer laserWavefront-optimized LASIK in one eye using the Allegretto excimer laser | Procedure or surgery | – |
Primary outcome
Changes in best corrected visual acuity
Time frame: 12 months
Changes in 5 and 25% contrast visual acuity
Time frame: 12 months
Refractive predictability
Time frame: 12 months
Uncorrected visual acuity
Time frame: 12 months
3 secondary outcomes
Changes in higher order aberrations
Time frame: 1 yr
Quality of vision measurement
Time frame: 1 yr
Topographic analysis
Time frame: 1 yr
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 8 Dec 2021.
- Results publication: PubMed 23778091Sales CS, Manche EE. One-year outcomes from a prospective, randomized, eye-to-eye comparison of wavefront-guided and wavefront-optimized LASIK in myopes. Ophthalmology. 2013 Dec;120(12):2396-2402. doi: 10.1016/j.ophtha.2013.05.010. Epub 2013 Jun 15.
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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.
Edward E. Manche principal investigator
Stanford University
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 Myopia and Astigmatism, run by Edward E. Manche 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 2 inclusion and 7 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 8 Dec 2021. 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?
Changes in best corrected visual acuity (time frame: 12 months). 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?
On the ClinicalTrials.gov record for NCT01138189, 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 8 Dec 2021.