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Visual Outcomes and Contrast Sensitivity After Myopic LASIK

Primary Purpose

Myopia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bilateral myopic LASIK
Sponsored by
Daniel S. Durrie, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring LASIK

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Durrie Vision

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

myopic LASIK procedure

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 7, 2012
Last Updated
January 25, 2013
Sponsor
Daniel S. Durrie, MD
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT01746589
Brief Title
Visual Outcomes and Contrast Sensitivity After Myopic LASIK
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel S. Durrie, MD
Collaborators
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
LASIK

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
myopic LASIK procedure
Arm Type
Other
Arm Description
All subjects will receive bilateral myopic LASIK procedure using the 200 kHz WaveLight® FS200 Femtosecond Laser and the WaveLight® Allegretto Wave® Eye-Q Laser
Intervention Type
Device
Intervention Name(s)
bilateral myopic LASIK
Other Intervention Name(s)
WaveLight® Femtosecond Laser and WaveLight® Allegretto®
Intervention Description
200 kHz WaveLight® FS200 Femtosecond Laser and the WaveLight® Allegretto Wave® Eye-Q Laser
Primary Outcome Measure Information:
Title
Change in Uncorrected Visual Acuity over time postoperatively
Description
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.
Time Frame
Postoperatively immediate (1-3 minutes), 30 minutes, 1 hour, 2 hours, 4 hours, 1 day, and 1 month
Secondary Outcome Measure Information:
Title
Change in contrast sensitivity postoperatively as compared to baseline
Description
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.
Time Frame
Postoperatively at immediately (1-3 minutes) after surgery, 30 minutes, 1 hour, 2 hours, 4 hours, 1 day and 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Durrie Vision
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States

12. IPD Sharing Statement

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Visual Outcomes and Contrast Sensitivity After Myopic LASIK

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