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Wavefront-guided vs. Topography-guided LASIK

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05588882
Collaborator
(none)
50
Enrollment
2
Arms
26.4
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The study is comparing outcomes of wavefront-guided LASIK to topography-guided LASIK in a randomized contralateral fellow eye study in myopic participants.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Wavefront-guided LASIK
  • Procedure: Wavefront-guided
 N/A

Detailed Description

The purpose of the study is to compare the results of wavefront-guided LASIK surgery to topography-guided LASIK surgery in participants with nearsightedness with or without astigmatism

We are using three FDA-approved laser devices for the study.

We are using two excimer lasers for the study. The excimer laser is used to perform the reshaping of the cornea under a LASIK flap to correct nearsightedness, farsightedness and astigmatism. We are using a Johnson and Johnson Visx CustomVue excimer laser and an Alcon Allegretto laser in the study. Both have received FDA-approval via a PMA pathway.

We are using one femtosecond laser for the study. The femtosecond laser is used to create the LASIK flap during the first part of the LASIK procedure. We are using an Intralase iFS150 femtosecond laser in the study. The femtosecond laser received FDA- approval via a 510k pathway.

All three lasers are being used according to their approved indications.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants contribute one eye to each study armParticipants contribute one eye to each study arm
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Prospective Randomized Comparison of Topography-Guided LASIK Surgery to Wavefront-Guided LASIK Surgery
Anticipated Study Start Date :
Oct 19, 2022
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Wavefront-guided LASIK

Wavefront-guided LASIK for myopia and myopic astigmatism

Procedure: Wavefront-guided LASIK
Topography-guided utilizes topography mapping to perform the ablation
Other Names:
  • Topography-guided LASIK

    		•
    Active Comparator: Topography-guided LASIK

    Topography-guided LASIK for myopia and myopic astigmatism

    Procedure: Wavefront-guided
    Wavefront-guided utilizes aberrometry to perform the ablation

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of eyes achieving uncorrected visual acuity [One year]

      Percentage of eyes achieving an uncorrected visual acuity of 20/40, 20/25 ,20/20, 20/16, 20/12.5 and 20/10 at post-operative month twelve

    Secondary Outcome Measures

    1. Percentage of eyes with a change in two or more lines of corrected visual acuity [One year]

      Percentage of eyes gaining or losing two or more lines of corrected visual acuity Percentage of eyes gaining or losing 2 or more lines of corrected distance visual acuity

    2. Predictability [One year]

      Percentage of eyes within +/- 0.50 and +/- 1.00 diopters of the intended corrected

    3. Patient Quality of Vision [One year]

      Percentage of patients preferring the eye that underwent either Wavefront-guided or Topography-guided LASIK

    4. Change in corneal epithelial thickness [One year]

      We will be measuring the average change in central corneal epithelial thickness from preoperative to post-operative month12 in eyes undergoing Wavefront-guided LASIK and Topography-guided LASIK

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 59 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Inclusion criteria.

    • Subjects ages 22 and older with healthy eyes. Nearsightedness between -1.00 diopters and -9.00 diopters.

    • Subjects with less than or equal to 3.00 diopters of astigmatism.

    Exclusion criteria.

    • Subjects under the age of 22.

    • Subjects with excessively thin corneas.

    • Subjects with topographic evidence of keratoconus.

    • Subjects with ectactic eye disorders.

    • Subjects with autoimmune diseases.

    • Subjects who are pregnant or nursing.

    • Subjects must have similar levels of nearsightedness in each eye. They cannot be more than 1.5 diopter of difference between eyes.

    • Subjects with more than 3.00 diopters of astigmatism

    • Subjects must have similar levels of astigmatism in each eye. They cannot have more than 1.00 diopters of difference between eyes.

    Contacts and Locations

    Locations

    No locations specified.

    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, Professor of Ophthalmology, Stanford University
    ClinicalTrials.gov Identifier:
    NCT05588882
    Other Study ID Numbers:
    • 63961
    First Posted:
    Oct 20, 2022
    Last Update Posted:
    Oct 20, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Edward E. Manche, Professor of Ophthalmology, Stanford University
    wavefront-guided
    topography-guided
    LASIK
    Additional relevant MeSH terms:
    Myopia

    Study Results

    No Results Posted as of Oct 20, 2022