Visual Outcomes and Contrast Sensitivity After Myopic LASIK

Myopia Clinical Trial

Official title:

Evaluation Of Visual Outcomes and Contrast Sensitivity After Myopic Wavefront-Optimized Lasik Using the 200 KHZ WAVELIGHT® FS200 Femtosecond Laser and the WAVELIGHT® ALLEGRETTO WAVE® EYE-Q Laser

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01746589
• Other study ID #: FS200SVR-10-2011
• Status: Completed
• Phase: Phase 4
• First received: December 7, 2012
• Last updated: January 25, 2013
• Start date: November 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2013
• Source: Durrie Vision
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• bilateral myopic LASIK
200 kHz WaveLight® FS200 Femtosecond Laser and the WaveLight® Allegretto Wave® Eye-Q Laser

Locations

Country	Name	City	State
United States	Durrie Vision	Overland Park	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Daniel S. Durrie, MD	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Uncorrected Visual Acuity over time postoperatively	Change in uncorrected visual acuity from baseline, postoperatively, immediately(1-3 minutes) after surgery, 30 minutes, 1 hour, 2 hours, 4 hours, 1 day, and 1 month.	Postoperatively immediate (1-3 minutes), 30 minutes, 1 hour, 2 hours, 4 hours, 1 day, and 1 month
Secondary	Change in contrast sensitivity postoperatively as compared to baseline	Contrast sensitivity (ability to distinguish between shades of gray) will be measured postoperatively immediately (1-3 minutes) after surgery, 30 minutes,1 hour, 2 hours, 4 hours, 1 day, and 1 month.	Postoperatively at immediately (1-3 minutes) after surgery, 30 minutes, 1 hour, 2 hours, 4 hours, 1 day and 1 month