Evaluation of Alcon Ladarvision Wavefront-Guided PRK

NCT ID: NCT00412295

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

Brief Summary

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

Conditions

Myopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Wavefront-guided PRK

Group Type: EXPERIMENTAL

Alcon Ladarvision (Wavefront-guided PRK)

Intervention Type: DEVICE

Wavefront-guided PRK using Alcon Ladarvision

Interventions

Alcon Ladarvision (Wavefront-guided PRK)

Wavefront-guided PRK using Alcon Ladarvision

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Walter Reed Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Samantha B. Rodgers, MD

PRS Account holder

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

STEVEN SCHALLHORN, MD

Role: PRINCIPAL_INVESTIGATOR

United States Naval Medical Center, San Diego

KRAIG S BOWER, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed Army Medical Center

Locations

Naval Medical Center

San Diego, California, United States

Walter Reed Army Medical Center, Center For Refractive Surgery

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

WRAMC WU#04-23006

Identifier Type: -

Identifier Source: org_study_id