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

NCT ID: NCT00413881

Last Updated: 2010-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2008-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2

Conventional LASIK Enhancement

Group Type: ACTIVE_COMPARATOR

CONVENTIONAL LASIK ENHANCEMENT

Intervention Type: PROCEDURE

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

1

Wavefront guided LASIK Enhancement

Group Type: EXPERIMENTAL

WAVEFRONT- GUIDED LASIK ENHANCEMENT

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

CONVENTIONAL LASIK ENHANCEMENT

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

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

Sponsors

Walter Reed Army Medical Center

FED

Sponsor Role: lead

Principal Investigators

RICHARD STUTZMAN, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed Army Medical Center

Locations

Walter Reed Army Medical Center, Center For Refractive Surgery

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

Countries

United States

Other Identifiers

WRAMC WU # 04-23011

Identifier Type: -

Identifier Source: org_study_id