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

NCT00413881 | Completed

• 1 other identifier: WRAMC WU # 04-23011
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Refractive Errors

Keywords

Residual refractive error left over from initial LASIK correction.; Higher Order aberrations measured using a wavefront analyzer.

Outcome Measures

Primary Outcomes (1)

• 1.Safety 2. Efficacy 3. Refractive stability

  one year after enhancement

Study Arms (2)

2

ACTIVE COMPARATOR

Conventional LASIK Enhancement

Procedure: CONVENTIONAL LASIK ENHANCEMENT

1

EXPERIMENTAL

Wavefront guided LASIK Enhancement

Procedure: WAVEFRONT- GUIDED LASIK ENHANCEMENT

Interventions

WAVEFRONT- GUIDED LASIK ENHANCEMENT PROCEDURE

Laser treatment to correct residual refractive error left over from initial LASIK correction using wavefront guided LADARvision 4000 excimer laser system

1

CONVENTIONAL LASIK ENHANCEMENT PROCEDURE

Laser treatment to correct residual refractive error left over from initial LASIK correction using LADARvision 4000 excimer laser system.

2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walter Reed Army Medical Center: lead

Study Sites (1)

Walter Reed Army Medical Center, Center For Refractive Surgery

Washington D.C., District of Columbia, 20307, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• RICHARD STUTZMAN, MD

  Walter Reed Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: December 19, 2006
• First Posted: December 20, 2006
• Study Start: July 1, 2004
• Study Completion: March 1, 2008
• Last Updated: January 14, 2010

Record last verified: 2008-03

Locations

US (1)