NCT01135719

Brief Summary

Subjects with myopia, hyperopia and astigmatism are being randomized to be treated in one eye with a wavefront-guided excimer laser and their fellow eye treated with a wavefront-optimized excimer laser.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 8, 2009

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2013

Completed
8.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2022

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

4.8 years

First QC Date

May 8, 2009

Last Update Submit

December 3, 2022

Conditions

HyperopiaMyopiaAstigmatism

Keywords

MyopiaHyperopiaAstigmatismPRKLASIK

Outcome Measures

Primary Outcomes (3)

  • Changes in best spectacle corrected visual acuity.

    One year

  • Changes in 25 and 5% low contrast visual acuity.

    One year

  • Improvement in uncorrected visual acuity

    One year

Secondary Outcomes (3)

  • Changes in higher order aberrations.

    One year

  • Topographic changes.

    One year

  • Quality of vision changes.

    One year

Study Arms (2)

Wavefront guided LASIK/PRK

ACTIVE COMPARATOR

Wavefront-guided LASIK/PRK

Procedure: LASIK and PRK

Wavefront optimized LASIK/PRK

ACTIVE COMPARATOR

Wavefornt optimized LASIK/PRK

Procedure: LASIK and PRK

Interventions

LASIK and PRKPROCEDURE

Wavefront-guided versus wavefront-optimized LASIK or PRK.

Also known as: Allegretto Wave Eye-Q 400 Hz excimer laser, Visx CustomVue excimer laser, Laser in-situ keratomileusis, Photorefractive keratectomy, Wavefront-guided, Wavefront-optimized
Wavefront guided LASIK/PRKWavefront optimized LASIK/PRK

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects age 21 and older.
  • Subjects with nearsightedness, farsightedness and/or astigmatism.

You may not qualify if:

  • Children.
  • Women pregnant or nursing.
  • Ectatic corneal disease.
  • Previous ocular surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (6)

  • Smith RG, Manche EE. One-Year Outcomes From a Prospective, Randomized, Eye-to-Eye Comparison of Wavefront-Guided and Wavefront-Optimized PRK in Myopia. J Refract Surg. 2020 Mar 1;36(3):160-168. doi: 10.3928/1081597X-20200129-01.

    PMID: 32159820BACKGROUND

  • Lee MD, Toy BC, Manche EE. Astigmatic outcomes in myopic wavefront-guided laser in situ keratomileusis versus wavefront-guided photorefractive keratectomy using vector analysis. J Cataract Refract Surg. 2018 Nov;44(11):1350-1354. doi: 10.1016/j.jcrs.2018.07.022. Epub 2018 Sep 7.

    PMID: 30201128BACKGROUND

  • He L, Manche EE. Contralateral eye-to-eye comparison of wavefront-guided and wavefront-optimized photorefractive keratectomy: a randomized clinical trial. JAMA Ophthalmol. 2015 Jan;133(1):51-9. doi: 10.1001/jamaophthalmol.2014.3876.

    PMID: 25321951BACKGROUND

  • Kung JS, Manche EE. Quality of Vision After Wavefront-Guided or Wavefront-Optimized LASIK: A Prospective Randomized Contralateral Eye Study. J Refract Surg. 2016 Apr;32(4):230-6. doi: 10.3928/1081597X-20151230-01.

    PMID: 27070229BACKGROUND

  • He L, Liu A, Manche EE. Wavefront-guided versus wavefront-optimized laser in situ keratomileusis for patients with myopia: a prospective randomized contralateral eye study. Am J Ophthalmol. 2014 Jun;157(6):1170-1178.e1. doi: 10.1016/j.ajo.2014.02.037. Epub 2014 Feb 19.

    PMID: 24560995BACKGROUND

  • Sales CS, Manche EE. One-year eye-to-eye comparison of wavefront-guided versus wavefront-optimized laser in situ keratomileusis in hyperopes. Clin Ophthalmol. 2014 Nov 12;8:2229-38. doi: 10.2147/OPTH.S70145. eCollection 2014.

    PMID: 25419115BACKGROUND

MeSH Terms

Conditions

HyperopiaMyopiaAstigmatism

Interventions

Keratomileusis, Laser In SituPhotorefractive Keratectomy

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, LaserLaser TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeKeratectomyRefractive Surgical ProceduresOphthalmologic Surgical Procedures

Study Officials

  • Edward E. Manche

    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
SPONSOR INVESTIGATOR
PI Title
Stanford University School of Medicine

Study Record Dates

First Submitted

May 8, 2009

First Posted

June 3, 2010

Study Start

April 1, 2009

Primary Completion

December 31, 2013

Study Completion

December 3, 2022

Last Updated

December 7, 2022

Record last verified: 2022-12

Locations

US(1)