Evaluation of Outcomes Using the Amo Advanced CustomVue Ilasik Procedure

NCT00765960 | Withdrawn

• 2 other identifiers: MRC 08-00218294
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Myopia; Hyperopia

Keywords

Vision

Outcome Measures

Primary Outcomes (1)

• 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.

  End of Study

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Magill Laser Center, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Kerry D Solomon, MD

  Professor of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 3, 2008
• Study Start: September 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2009
• Last Updated: June 6, 2018

Record last verified: 2010-10

Locations

US (1)