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Evaluation of Outcomes Using the Amo Advanced CustomVue Ilasik Procedure (iLASIK)

This study has been terminated.
(Prinicipal Investigator separating employment from University.)
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00765960
First received: October 1, 2008
Last updated: August 11, 2011
Last verified: October 2010

October 1, 2008
August 11, 2011
September 2008
October 2008   (final data collection date for primary outcome measure)
Comparisons and statistical analysis will be done to determine if any statistical differences exist between preoperative and postoperative visits, and assess the efficacy, predictability and safety of the Advanced CustomVue™ iLASIK procedure. [ Time Frame: End of Study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00765960 on ClinicalTrials.gov Archive Site
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Evaluation of Outcomes Using the Amo Advanced CustomVue Ilasik Procedure
Evaluation of Outcomes Using the Amo Advanced CustomVue Ilasik Procedure

The purpose of this study is to assess the efficacy, predictability and safety of the Advanced CustomVue™ iLASIK procedure (WaveScan WaveFront® System, STAR S4 IR™ Excimer Laser System and IntraLase™ FS System).

Laser in situ keratomileusis (LASIK) surgery has been performed worldwide since 1990. More recently, customized corneal ablation utilizing wavefront-sensing technology to determine the optical aberration of a patient's cornea has optimized LASIK surgery results. Prior to the introduction of wavefront-guided laser vision correction, the variables used for correcting refractive errors were limited to sphere and cylinder. With the introduction of wavefront laser vision correction surgeons are now able to provide individualized laser-induced corneal tissue resection based not only on sphere and cylinder measurements, but also on an attempt to treat 3rd through 6th higher-order aberrations (HOAs) utilizing Zernike polynomial wavefront reconstructions and Fourier transformation.

Advanced Medical Optics, Inc. (AMO) has recently introduced the Advanced CustomVue™ iLASIK procedure which utilizes the WaveScan WaveFront® System, a STAR S4 IR™ Excimer Laser System and IntraLase™ FS System technology to provide the broadest range of wavefront-guided FDA approved usages and an unprecedented level of precision and accuracy for patients undergoing LASIK surgery. The procedure leverages Iris Registration, Fourier algorithms, VSS™ and VRR™ technologies and 3D ActiveTrak™ to ensure precise corneal ablation.1, 2

Observational
Time Perspective: Retrospective
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Probability Sample

Approximately 20 patients (40 eyes) of both sexes and any race undergoing bilateral wavefront-guided LASIK will be included.

  • Myopia
  • Hyperopia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
0
October 2009
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:Subjects MUST fulfill the following conditions to qualify for enrollment into the trial Both eyes must have a manifest refractive error from -0.50 D to -6.00 D, a cylinder component up to -3.00 D, and a maximum manifest spherical equivalent of -6.00 D.

21 years of age or older at the time of the pre-operative examination. Both eyes must have a BSCVA of 20/20 or better; Both eyes must have a minimum pupil size of at least 6.0mm in dim illumination on wavescan.

Both eyes must demonstrate refractive stability confirmed by clinical records or previous glasses. Refractive stability shall be documented by a change of less than or equal to 0.50 diopter (sphere and cylinder) at an exam at least 12 months prior to the baseline examination. The astigmatic axis must also be within 15 degrees for eyes with cylinder greater than 0.50 D.

Willing and able to comply with scheduled visits and other study procedures.

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Exclusion Criteria:Subjects with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial.

Subjects who use concurrent topical or systemic medications that may impair healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment. Also, the use of topical or systemic corticosteroids, whether chronic or acute Subjects with a history of any of the following medical conditions, or any other condition that could affect wound healing: uncontrolled diabetes, collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis.

Subject must not have a history of prior intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization > 1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring), or with evidence of glaucoma or propensity for narrow angle glaucoma in either eye.

The subject must not have any evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.

Subjects with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.

Patients who do not achieve Iris registration at the time of their wavescan. Patients seeking monovision Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.

Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates the patient is unsuitable for the trial.

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Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00765960
MRC 08-002, 18294
No
Kerry D. Solomon, Magill Research Center
Medical University of South Carolina
Not Provided
Principal Investigator: Kerry D Solomon, MD Professor of Ophthalmology
Medical University of South Carolina
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP