A Prospective Comparison of Alcon LADARVision Wavefront-guided LASIK Enhancement and Conventional LASIK Enhancement for the Correction of Residual Refractive Errors Following LASIK Procedures
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|ClinicalTrials.gov Identifier: NCT00413881|
Recruitment Status : Completed
First Posted : December 20, 2006
Last Update Posted : January 14, 2010
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|Condition or disease||Intervention/treatment||Phase|
|Refractive Errors||Procedure: WAVEFRONT- GUIDED LASIK ENHANCEMENT Procedure: CONVENTIONAL LASIK ENHANCEMENT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||July 2004|
|Actual Study Completion Date :||March 2008|
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.
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
- 1.Safety 2. Efficacy 3. Refractive stability [ Time Frame: one year after enhancement ]
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|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413881
|United States, District of Columbia|
|Walter Reed Army Medical Center, Center For Refractive Surgery|
|Washington, District of Columbia, United States, 20307|
|Principal Investigator:||RICHARD STUTZMAN, MD||Walter Reed Army Medical Center|
|Other Study ID Numbers:||
WRAMC WU # 04-23011
|First Posted:||December 20, 2006 Key Record Dates|
|Last Update Posted:||January 14, 2010|
|Last Verified:||March 2008|
Residual refractive error left over from initial LASIK correction.
Higher Order aberrations measured using a wavefront analyzer.