Wavefront-guided vs. Topography-guided LASIK

Myopia Clinical Trial

Official title:

A Prospective Randomized Comparison of Topography-Guided LASIK Surgery to Wavefront-Guided LASIK Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05588882
• Other study ID #: 63961
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 19, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Three FDA-approved laser devices are being used for the study.

Two excimer lasers are being used 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. The two lasers being utilized are the Johnson and Johnson Visx CustomVue excimer laser and the Alcon Allegretto laser in the study. Both have received FDA-approval via a PMA pathway.

One femtosecond laser is being used in the study. The femtosecond laser is used to create the LASIK flap during the first part of the LASIK procedure. The Intralase iFS150 femtosecond laser is being used in the study. The femtosecond laser received FDA- approval via a 510k pathway.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 59 Years

Eligibility

Inclusion criteria.

• Subjects ages 22 to 59with 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 and over the age of 59

• 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.

Related Conditions & MeSH terms

• Myopia

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of eyes achieving uncorrected visual acuity	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	One year
Secondary	Percentage of eyes with a change in two or more lines of corrected visual acuity	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	One year
Secondary	Predictability	Percentage of eyes within +/- 0.50 and +/- 1.00 diopters of the intended corrected	One year
Secondary	Patient Quality of Vision	Percentage of patients preferring the eye that underwent either Wavefront-guided or Topography-guided LASIK	One year
Secondary	Change in corneal epithelial thickness	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	One year