High Resolution Wavefront-guided vs. Wavefront Optimized LASIK

NCT02565537 | Completed

• 1 other identifier: 34288
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Nearsightedness; Astigmatism

Outcome Measures

Primary Outcomes (1)

• Uncorrected visual acuity

  Twelve months

Secondary Outcomes (5)

• Quality of vision and quality of life using the QoV questionnaire

  One month, three months, six months and twelve months

• Changes in higher order aberrations (Coma, trefoil, spherical aberration, total higher order RMS)

  One day, one month, three months, six months and twelve months

• 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

• Change in best spectacle corrected visual acuity

  One, three, six and twelve months

• 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

Study Arms (2)

iDesign WFG LASIK

ACTIVE COMPARATOR

Wavefront-guided LASIK

Procedure: LASIK

Wavelight WFO LASIK

ACTIVE COMPARATOR

Wavefront-optimized LASIK

Procedure: LASIK

Interventions

LASIK PROCEDURE

WFG vs. WFO LASIK

Wavelight WFO LASIK; iDesign WFG LASIK

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94303, United States

Location

Related Publications (1)

• 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.

  PMID: 34788593 BACKGROUND

MeSH Terms

Conditions

Myopia; Astigmatism

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, Laser; Laser Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Keratectomy; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures

Study Officials

• Edward E. Manche, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 1, 2015
• Study Start: October 1, 2015
• Primary Completion: June 30, 2021
• Study Completion: April 1, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

US (1)