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

Sponsor
Walter Reed Army Medical Center (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00413881
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
44
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: WAVEFRONT- GUIDED LASIK ENHANCEMENT
  • Procedure: CONVENTIONAL LASIK ENHANCEMENT
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Jul 1, 2004
Actual Study Completion Date :
Mar 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 1.Safety 2. Efficacy 3. Refractive stability [one year after enhancement]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Walter Reed Army Medical Center, Center For Refractive Surgery Washington District of Columbia United States 20307

Sponsors and Collaborators

  • Walter Reed Army Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00413881
Other Study ID Numbers:
  • WRAMC WU # 04-23011
First Posted:
Dec 20, 2006
Last Update Posted:
Jan 14, 2010
Last Verified:
Mar 1, 2008
Keywords provided by , ,
Residual refractive error left over from initial LASIK correction.
Higher Order aberrations measured using a wavefront analyzer.
Additional relevant MeSH terms:
Refractive Errors

Study Results

No Results Posted as of Jan 14, 2010