Visual Outcomes and Contrast Sensitivity After Myopic LASIK

NCT ID: NCT01746589

Last Updated: 2013-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-01-31

Brief Summary

Evaluate visual outcomes and contrast sensitivity for subjects undergoing bilateral myopic LASIK procedure using the 200 kHz WaveLight® FS200 Femtosecond Laser and the WaveLight® Allegretto Wave® Eye-Q Laser. The use of advanced technology may decrease the loss of contrast sensitivity and improvement of postoperative visual acuity results.

Conditions

Myopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

myopic LASIK procedure

All subjects will receive bilateral myopic LASIK procedure using the 200 kHz WaveLight® FS200 Femtosecond Laser and the WaveLight® Allegretto Wave® Eye-Q Laser

Group Type: OTHER

bilateral myopic LASIK

Intervention Type: DEVICE

200 kHz WaveLight® FS200 Femtosecond Laser and the WaveLight® Allegretto Wave® Eye-Q Laser

Interventions

bilateral myopic LASIK

200 kHz WaveLight® FS200 Femtosecond Laser and the WaveLight® Allegretto Wave® Eye-Q Laser

Intervention Type: DEVICE

Other Intervention Names

WaveLight® Femtosecond Laser and WaveLight® Allegretto®

Eligibility Criteria

Inclusion Criteria

• Male or female in good general health, 18 years of age or older at the time of the pre-operative examination
• Patient must be able to read, comprehend and willing to give HIPPA and informed consent
• Patient is planning to undergo a bilateral LASIK procedure
• Both eyes must have a manifest refractive error from -1.00 D to -7.00 spherical equivalent with less than or equal to 3.00D of refractive astigmatism as expressed in spectacle minus cylinder form
• Both eyes must have a BSCVA of 20/20 or better
• Both eyes must demonstrate refractive stability confirmed by clinical records, previous glasses, or investigator's discretion.
• Patient must be willing to comply with study dosing and complete the entire course of the study.

Exclusion Criteria

• A patient with evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye
• A patient seeking monovision
• A patient with a known hypersensitivity to any of the components of the procedural or post-LASIK medications
• A patient requiring the use of any ocular drop(s) and/or medication(s) in either eye during the study period with the exception of ocular drops and/or medications provided by the investigator
• A patient having any surgical procedure within a week preceding the scheduled LASIK surgery
• A patient with any UNCONTROLLED systemic disease (i.e., a potential patient in whom therapy for a systemic disease is not yet stabilized )
• A patient with a history of prior intraocular or corneal surgery (including cataract extraction), active clinically significant 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) inside the visual axis, or evidence of glaucoma or propensity for narrow angle glaucoma in either eye
• A patient with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, may increase the risk associated with study participation or may interfere with the interpretation of study results
• A patient 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
• Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

Daniel S. Durrie, MD

OTHER

Sponsor Role: lead

Responsible Party

Daniel S. Durrie, MD

President

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Durrie Vision

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

FS200SVR-10-2011

Identifier Type: -

Identifier Source: org_study_id