High Resolution Wavefront-guided vs. Wavefront Optimized LASIK

Sponsor
Stanford University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02565537
Collaborator
(none)
100
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122
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: LASIK
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective Randomized Comparison of the AMO CustomVue to the Alcon Wavelight in Patients Undergoing LASIK
Actual Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: iDesign WFG LASIK

Wavefront-guided LASIK

Procedure: LASIK
WFG vs. WFO LASIK

Active Comparator: Wavelight WFO LASIK

Wavefront-optimized LASIK

Procedure: LASIK
WFG vs. WFO LASIK

Outcome Measures

Primary Outcome Measures

  1. Uncorrected visual acuity [Twelve months]

Secondary Outcome Measures

  1. Quality of vision and quality of life using the QoV questionnaire [One month, three months, six months and twelve months]

  2. Changes in higher order aberrations (Coma, trefoil, spherical aberration, total higher order RMS) [One day, one month, three months, six months and twelve months]

  3. Predictability of refractive outcomes (Percentage of eyes +/- 0.25 diopters, +/- 0.50 diopters and +/- 1.00 diopters of the intended correction) [One, three, six and twelve months]

  4. Change in best spectacle corrected visual acuity [One, three, six and twelve months]

  5. Vector analysis of astigmatic outcomes (The Alpins method looking at Target induced astigmatism, Surgical induced astigmatism, Index of Success [One, three six and twelve months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University School of Medicine Palo Alto California United States 94303

Sponsors and Collaborators

  • Stanford University

Investigators

  • Principal Investigator: Edward E. Manche, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Edward E. Manche, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier:
NCT02565537
Other Study ID Numbers:
  • 34288
First Posted:
Oct 1, 2015
Last Update Posted:
Nov 9, 2021
Last Verified:
Nov 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2021