Back to resultsHigh Resolution Wavefront-guided vs. Wavefront Optimized LASIK
Primary Purpose
Nearsightedness, Astigmatism
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LASIK
Sponsored by
About this trial
This is an interventional treatment trial for Nearsightedness
Eligibility Criteria
Inclusion criteria.
- Subjects age 21 and older with healthy eyes.
- Nearsightedness between -0.25 diopters and -11.00 diopters with or without astigmatism of up to 5.00 diopters.
Exclusion criteria.
- Subjects under the age of 21.
- Patients with excessively thin corneas.
- Patients with topographic evidence of keratoconus.
- Patients with ectatic eye disorders.
- Patients with autoimmune diseases.
- Patients who are pregnant or nursing.
- Patients must have similar levels of nearsightedness and farsightedness in each eye. They can not be more than 1.5 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.
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
iDesign WFG LASIK
Wavelight WFO LASIK
Arm Description
Wavefront-guided LASIK
Wavefront-optimized LASIK
Outcomes
Primary Outcome Measures
Uncorrected visual acuity
Secondary Outcome Measures
Quality of vision and quality of life using the QoV questionnaire
Changes in higher order aberrations (Coma, trefoil, spherical aberration, total higher order RMS)
Predictability of refractive outcomes (Percentage of eyes +/- 0.25 diopters, +/- 0.50 diopters and +/- 1.00 diopters of the intended correction)
Change in best spectacle corrected visual acuity
Vector analysis of astigmatic outcomes (The Alpins method looking at Target induced astigmatism, Surgical induced astigmatism, Index of Success
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02565537
Brief Title
High Resolution Wavefront-guided vs. Wavefront Optimized LASIK
Official Title
A Prospective Randomized Comparison of the AMO CustomVue to the Alcon Wavelight in Patients Undergoing LASIK
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2015 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators are comparing outcomes of LASIK surgery using a high definition wavefront-guided laser to a wavefront-optimized laser in patients with nearsightedness with and without astigmatism.
Detailed Description
The patients will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the patient from the study, then the investigators will inform the patient and make an appropriate referral. if the patient is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. The patient will undergo bilateral simultaneous eye surgery. Which eye is treated with the CustomVue and which eye is treated with Wavelight will be randomized so there is a 50% chance for either eye to receive one treatment. The patients will be seen on the day of surgery, post op day one, one month, three months, six months and one year. The patient will receive topical antibiotics in each eye for one week following the procedure. The patient will receive pred forte 1% ophthalmic drops for one week after treatment. The patient will also receive vigamox ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing LASIK surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nearsightedness, Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iDesign WFG LASIK
Arm Type
Active Comparator
Arm Description
Wavefront-guided LASIK
Arm Title
Wavelight WFO LASIK
Arm Type
Active Comparator
Arm Description
Wavefront-optimized LASIK
Intervention Type
Procedure
Intervention Name(s)
LASIK
Intervention Description
WFG vs. WFO LASIK
Primary Outcome Measure Information:
Title
Uncorrected visual acuity
Time Frame
Twelve months
Secondary Outcome Measure Information:
Title
Quality of vision and quality of life using the QoV questionnaire
Time Frame
One month, three months, six months and twelve months
Title
Changes in higher order aberrations (Coma, trefoil, spherical aberration, total higher order RMS)
Time Frame
One day, one month, three months, six months and twelve months
Title
Predictability of refractive outcomes (Percentage of eyes +/- 0.25 diopters, +/- 0.50 diopters and +/- 1.00 diopters of the intended correction)
Time Frame
One, three, six and twelve months
Title
Change in best spectacle corrected visual acuity
Time Frame
One, three, six and twelve months
Title
Vector analysis of astigmatic outcomes (The Alpins method looking at Target induced astigmatism, Surgical induced astigmatism, Index of Success
Time Frame
One, three six and twelve months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria.
Subjects age 21 and older with healthy eyes.
Nearsightedness between -0.25 diopters and -11.00 diopters with or without astigmatism of up to 5.00 diopters.
Exclusion criteria.
Subjects under the age of 21.
Patients with excessively thin corneas.
Patients with topographic evidence of keratoconus.
Patients with ectatic eye disorders.
Patients with autoimmune diseases.
Patients who are pregnant or nursing.
Patients must have similar levels of nearsightedness and farsightedness in each eye. They can not be more than 1.5 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward E. Manche, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34788593
Citation
Chiang B, Valerio GS, Manche EE. Prospective, Randomized Contralateral Eye Comparison of Wavefront-Guided Laser In Situ Keratomileusis and Small Incision Lenticule Extraction Refractive Surgeries. Am J Ophthalmol. 2022 May;237:211-220. doi: 10.1016/j.ajo.2021.11.013. Epub 2021 Nov 14.
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High Resolution Wavefront-guided vs. Wavefront Optimized LASIK
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