A Prospective Comparison of Alcon LADARVision Wavefront-guided LASIK Enhancement and Conventional LASIK Enhancement for the Correction of Residual Refractive Errors Following LASIK Procedures

The purpose of this study is to conduct a prospective clinical trial to compare conventional and WFG LASIK for enhancements on post-LASIK patients. Differences in safety, efficacy, visual quality, and refractive stability will also be compared during this study.

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• Intervention / Treatment: Procedure: CONVENTIONAL LASIK ENHANCEMENT; Procedure: WAVEFRONT- GUIDED LASIK ENHANCEMENT

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • 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
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, of any race, and at least 21 years old at the time of the preoperative exam, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
• At least 6 months from original LASIK surgery.
• Stable refraction with more than 0.75D of spherical equivalent from the desired correction and have less than 1.50D of cylinder in the manifest refraction.
• Both eyes must be within 1.00D spherical equivalent of each other on the manifest refraction test.
• The eye to be treated with wavefront-guided enhancement must have at least a 9.5mm flap.
• Manifest refraction and LADARWave™ refractions must be within 1.00D.
• At least 3 lines potential improvement in UCVA.
• BSCVA of 20/20 or better.
• Good corneal flap and interface.
• Adequate corneal thickness for surgery (residual stromal bed > 280 microns).
• Able and willing to give informed consent.
• Located in the greater Washington DC area for a 12-month period.
• 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. Pregnancy will be ruled out with a urine pregnancy test.
• Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or sumatripin, as determined by history.
• Medical condition(s), which, in the judgement of the investigator, may impair healing, including but not limited to: collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex (As determined by history).
• 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.
• Flap irregularity(striae, interface debris, scarring, or epithelium).
• Calculated residual stroma bed less than 280.
• Stable refraction with less than 0.75D of spherical equivalent from the desired correction and more than 1.5D of cylinder in the manifest refraction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2; Conventional LASIK Enhancement	Procedure: CONVENTIONAL LASIK ENHANCEMENT; Laser treatment to correct residual refractive error left over from initial LASIK correction using LADARvision 4000 excimer laser system.
Experimental: 1; Wavefront guided LASIK Enhancement	Procedure: WAVEFRONT- GUIDED LASIK ENHANCEMENT; Laser treatment to correct residual refractive error left over from initial LASIK correction using wavefront guided LADARvision 4000 excimer laser system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1.Safety 2. Efficacy 3. Refractive stability	one year after enhancement

Collaborators and Investigators

• Sponsor: Walter Reed Army Medical Center
• Investigators: Principal Investigator: RICHARD STUTZMAN, MD, Walter Reed Army Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: December 19, 2006
• First Submitted That Met QC Criteria: December 19, 2006
• First Posted (Estimate): December 20, 2006

Study Record Updates

• Last Update Posted (Estimate): January 14, 2010
• Last Update Submitted That Met QC Criteria: January 13, 2010
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: Residual refractive error left over from initial LASIK correction.; Higher Order aberrations measured using a wavefront analyzer.
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: WRAMC WU # 04-23011