Evaluation of Alcon Ladarvision Wavefront-Guided PRK

Myopia Clinical Trial

Official title:

Evaluation of Alcon Ladarvision Wavefront-Guided PRK

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00412295
• Other study ID #: WRAMC WU#04-23006
• Status: Withdrawn
• Phase: N/A
• First received: December 15, 2006
• Last updated: January 12, 2015

Study information

• Verified date: December 2014
• Source: Walter Reed Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Alcon Ladarvision (Wavefront-guided PRK)
Wavefront-guided PRK using Alcon Ladarvision

Locations

Country	Name	City	State
United States	Naval Medical Center	San Diego	California
United States	Walter Reed Army Medical Center, Center For Refractive Surgery	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego	Walter Reed Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corrected distance visual acuity (CDVA)	CDVA (logMAR unit and/or snellen equivalent) will be measured to determine safety of wavefront guided PRK.	12 months	Yes
Primary	Uncorrected distance visual acuity (UDVA)	UDVA (logMAR unit and/or snellen equivalent) will be measured to determine effectiveness of wavefront guided PRK.	12 months	No