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A Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser

Primary Purpose

Hyperopia, Myopia, Astigmatism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LASIK and PRK
Sponsored by
Edward E. Manche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperopia focused on measuring Myopia, Hyperopia, Astigmatism, PRK, LASIK

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:Autoimmune diseases.

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Wavefront guided LASIK/PRK

Wavefront optimized LASIK/PRK

Arm Description

Wavefront-guided LASIK/PRK

Wavefornt optimized LASIK/PRK

Outcomes

Primary Outcome Measures

Changes in best spectacle corrected visual acuity.
Changes in 25 and 5% low contrast visual acuity.
Improvement in uncorrected visual acuity

Secondary Outcome Measures

Changes in higher order aberrations.
Topographic changes.
Quality of vision changes.

Full Information

First Posted
May 8, 2009
Last Updated
December 3, 2022
Sponsor
Edward E. Manche
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1. Study Identification

Unique Protocol Identification Number
NCT01135719
Brief Title
A Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser
Official Title
A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 2009 (Actual)
Primary Completion Date
December 31, 2013 (Actual)
Study Completion Date
December 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Edward E. Manche

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Subjects with myopia, hyperopia and astigmatism are being randomized by ocular dominance to be treated with either PRK or LASIK. One eye will be treated with a wavefront-guided excimer laser and the fellow eye will be treated with a wavefront optimized excimer laser.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperopia, Myopia, Astigmatism
Keywords
Myopia, Hyperopia, Astigmatism, PRK, LASIK

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wavefront guided LASIK/PRK
Arm Type
Active Comparator
Arm Description
Wavefront-guided LASIK/PRK
Arm Title
Wavefront optimized LASIK/PRK
Arm Type
Active Comparator
Arm Description
Wavefornt optimized LASIK/PRK
Intervention Type
Procedure
Intervention Name(s)
LASIK and PRK
Other Intervention Name(s)
Allegretto Wave Eye-Q 400 Hz excimer laser, Visx CustomVue excimer laser, Laser in-situ keratomileusis, Photorefractive keratectomy, Wavefront-guided, Wavefront-optimized
Intervention Description
Wavefront-guided versus wavefront-optimized LASIK or PRK.
Primary Outcome Measure Information:
Title
Changes in best spectacle corrected visual acuity.
Time Frame
One year
Title
Changes in 25 and 5% low contrast visual acuity.
Time Frame
One year
Title
Improvement in uncorrected visual acuity
Time Frame
One year
Secondary Outcome Measure Information:
Title
Changes in higher order aberrations.
Time Frame
One year
Title
Topographic changes.
Time Frame
One year
Title
Quality of vision changes.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy subjects age 21 and older. Subjects with nearsightedness, farsightedness and/or astigmatism. Exclusion Criteria:Autoimmune diseases. Children. Women pregnant or nursing. Ectatic corneal disease. Previous ocular surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward E. Manche
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32159820
Citation
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.
Results Reference
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PubMed Identifier
30201128
Citation
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.
Results Reference
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PubMed Identifier
25321951
Citation
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. Erratum In: JAMA Ophthalmol. 2015 May;133(5):621.
Results Reference
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PubMed Identifier
27070229
Citation
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.
Results Reference
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PubMed Identifier
24560995
Citation
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.
Results Reference
background
PubMed Identifier
25419115
Citation
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.
Results Reference
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A Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser

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