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

Refractive Errors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413881
• Other study ID #: WRAMC WU # 04-23011
• Status: Completed
• Phase: N/A
• First received: December 19, 2006
• Last updated: January 13, 2010
• Start date: July 2004
• Est. completion date: March 2008

Study information

• Verified date: March 2008
• Source: Walter Reed Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Refractive Errors

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1.Safety 2. Efficacy 3. Refractive stability		one year after enhancement