- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02091934
Wavefront-guided PRK vs Wavefront-optimized PRK
A Prospective, Randomized Comparison of Fellow Eyes Undergoing Wavefront-guided PRK Versus Wavefront-optimized PRK Using the Alcon Allegretto Eye-Q 400 Excimer Laser
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a research study comparing the outcomes of PRK 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 50 sighted patients at Stanford to undergo treatment in this clinical research trial. This will be a prospective, randomized, research study in which up to 100 consecutive eyes scheduled to undergo excimer laser photo refractive keratectomy (PRK) 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 not 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) PRK 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 PRK 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. Patients will complete questionnaires preoperatively and postoperatively evaluating quality of vision and quality of life. 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 PRK 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Palo Alto, California, United States, 94303
- Stanford Eye Laser Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects age 21 and older with healthy eyes.
- Nearsightedness between -0.25 diopters and -8.00 diopters with or without astigmatism of up to 5.00 diopters.
Exclusion Criteria:
- Subjects under the age of 21.
- Excessively thin corneas.
- Topographic evidence of keratoconus.
- Ectactic eye disorders.
- Autoimmune diseases.
- Pregnant or nursing.
- Patients must have similar levels of nearsightedness in each eye. They can not be more than 2.5 diopter of difference between eyes.
- Patients must have similar levels of astigmatism in each eye. They can not have more than 1.5 diopter of difference between eyes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Wavefront-guided PRK
|
Wavefront-guided PRK
Other Names:
|
Active Comparator: Wavefront-optimized PRK
|
Wavefront-optimized PRK
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Uncorrected visual acuity
Time Frame: One year
|
Uncorrected visual acuity
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Topographic analysis
Time Frame: One year
|
Topographic analysis
|
One year
|
Wavefront analysis
Time Frame: One year
|
Wavefront analysis
|
One year
|
Quality of vision and quality of life questionnaire
Time Frame: One year
|
Patient Reported Outcomes Questionnaire
|
One year
|
Corneal haze
Time Frame: One year
|
Corneal haze
|
One year
|
Changes in best corrected 5 and 25% contrast visual acuity
Time Frame: One year
|
Changes in best corrected 5 and 25% contrast visual acuity
|
One year
|
Changes in best corrected visual acuity
Time Frame: One year
|
Changes in best corrected visual acuity
|
One year
|
Refractive predictability
Time Frame: One year
|
Refractive predictability
|
One year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Stanford IRB #29233
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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