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

NCT ID: NCT01135719

Last Updated: 2022-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2022-12-03

Brief Summary

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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

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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.

Conditions

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Hyperopia Myopia Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Wavefront guided LASIK/PRK

Wavefront-guided LASIK/PRK

Group Type ACTIVE_COMPARATOR

LASIK and PRK

Intervention Type PROCEDURE

Wavefront-guided versus wavefront-optimized LASIK or PRK.

Wavefront optimized LASIK/PRK

Wavefornt optimized LASIK/PRK

Group Type ACTIVE_COMPARATOR

LASIK and PRK

Intervention Type PROCEDURE

Wavefront-guided versus wavefront-optimized LASIK or PRK.

Interventions

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LASIK and PRK

Wavefront-guided versus wavefront-optimized LASIK or PRK.

Intervention Type PROCEDURE

Other Intervention Names

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Allegretto Wave Eye-Q 400 Hz excimer laser Visx CustomVue excimer laser Laser in-situ keratomileusis Photorefractive keratectomy Wavefront-guided Wavefront-optimized

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Children.
* Women pregnant or nursing.
* Ectatic corneal disease.
* Previous ocular surgery.
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Edward E. Manche

OTHER

Sponsor Role lead

Responsible Party

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Edward E. Manche

Stanford University School of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Edward E. Manche

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 32159820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30201128 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25321951 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27070229 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24560995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25419115 (View on PubMed)

Other Identifiers

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SU-04302009-2458

Identifier Type: -

Identifier Source: org_study_id

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