Evaluation of Alcon Ladarvision Wavefront-Guided PRK

This study has been completed.
Sponsor:
Collaborator:
Walter Reed Army Medical Center
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00412295
First received: December 15, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

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

Condition Intervention
Myopia
Procedure: Wavefront guided PRK

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of Alcon Ladarvision Wavefront-Guided PRK

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412295

Locations
United States, California
Naval Medical Center
San Diego, California, United States, 92134
United States, District of Columbia
Walter Reed Army Medical Center, Center For Refractive Surgery
Washington, District of Columbia, United States, 20307
Sponsors and Collaborators
United States Naval Medical Center, San Diego
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00412295     History of Changes
Other Study ID Numbers: WRAMC WU#04-23006
Study First Received: December 15, 2006
Last Updated: December 15, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Walter Reed Army Medical Center:
Naturally occuring myopia with or without astigmatism.
Wavefront errors

ClinicalTrials.gov processed this record on October 01, 2014