Evaluation of Alcon Ladarvision Wavefront-Guided PRK

The purpose of this study is to:

1. determine the safety of wavefront guided PRK
2. evaluate the efficacy of wavefront guided PRK
3. evaluate the differences in visual quality after treatment of wavefront guided PRK

Study Overview

• Status: Withdrawn
• Conditions: Myopia
• Intervention / Treatment: Device: Alcon Ladarvision (Wavefront-guided PRK)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92134
      • Naval Medical Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20307
      • Walter Reed Army Medical Center, Center For Refractive Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects will be recruited from those active duty soldiers that have requested refractive surgery. Subjects must be eligible for medical care at WRAMC.
• Male or female, of any race, and at least 21 years old at the time of the pre-operative examination, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
• Manifest refractive spherical equivalent (MSE) of up to -6 diopters (D) at the spectacle plane with refractive cylinder up to 3.00D.
• At least five images must be capturesd in both eyes (dilated) with a pupil size of at least 7mm.
• Manifest refraction and LADARWave™ refractions must be within 1.00 D and the CustomCornea® software must allow for treatment with a 6.5mm minor axis and 9mm ablation zone.
• Best spectacle corrected visual acuity of 20/20 or better in both eyes.
• Demonstrated refractive stability, confirmed by clinical records. Neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50D during the 12-month period immediately preceding the baseline examination, sa confirmed by clinical records.
• Soft contact lens users must have removed their lenses at least 2 weeks before baseline measurements. Hard contact lens users (PMMA or rigid gas permeable lenses) must have removed their lenses at least 4 weeks prior to baseline measurements adn have 2 central Keratometry readings and 2 manifest refractions taken at least 1 week apart that do not differ by more than 0.50D in either meridian; mires should be regular.
• Located it the greater Washington DC Area for a 12-month period.
• Exhibits strong motivation for attending the follow-up visits.
• Consent of the subject's command (active duty) to participate in the study.
• Access to transportation to meet follow-up requirements.

Exclusion Criteria:

• Female subjects who are pregnant, breast feeding or intend to become pregnant during the study.
• Concurrent topical or systemic medications that may impair healing, including corticosteriods, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or sumatripin.
• Medical condition(s), which, in the judgement of the investigator, may impair healing, including but not limited to: collagen vascular diseases and ocular herpes zoster or simplex.
• Active ophthalmic disease, neovascularization of the cornea within 1mm of the intended ablation zone, or clinically significant lens opacity.
• Evidence of glaucoma or an intraocular pressure greater than 22mm Hg at baseline.
• Evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
• History of recurrent erosions or epithelial baewsment dystrophy.
• Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
• Any physical or mental impairment that would preclude participation in any of the examinations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Wavefront-guided PRK	Device: Alcon Ladarvision (Wavefront-guided PRK); Wavefront-guided PRK using Alcon Ladarvision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corrected distance visual acuity (CDVA)	CDVA (logMAR unit and/or snellen equivalent) will be measured to determine safety of wavefront guided PRK.	12 months
Uncorrected distance visual acuity (UDVA)	UDVA (logMAR unit and/or snellen equivalent) will be measured to determine effectiveness of wavefront guided PRK.	12 months

Collaborators and Investigators

• Sponsor: Walter Reed Army Medical Center
• Collaborators: Walter Reed Army Medical Center
• Investigators: Principal Investigator: STEVEN SCHALLHORN, MD, United States Naval Medical Center, San Diego; Principal Investigator: KRAIG S BOWER, MD, Walter Reed Army Medical Center

Study record dates

Study Registration Dates

• First Submitted: December 15, 2006
• First Submitted That Met QC Criteria: December 15, 2006
• First Posted (Estimated): December 18, 2006

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Naturally occuring myopia with or without astigmatism.; Wavefront errors
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: WRAMC WU#04-23006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes