The Effect of Hinge Position and Hinge Width on Corneal Sensation and Dry Eye After IntraLase LASIK Procedure (IDES)
Primary Purpose
Myopia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LASIK
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring IntraLase LASIK for primary myopia
Eligibility Criteria
Inclusion Criteria:
- Refractive error: Myopia < 12 D, with astigmatism < 3 D,
- Age > 20 y/o
- Regular corneal curvature, sufficient corneal thickness, appropriate pupil size, normal slit lamp examination
- Informed consent to permit us to use their records for this study without using name, medical record number, or date of surgery.
Exclusion Criteria:
- Pregnant/nursing
- Systemic collagen vascular disease
- Autoimmune disease
- Severe dry eyes
Sites / Locations
- Cornea Clinic, Kellogg Eye Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Hinge position
Hinge width
Flap Thickness
Arm Description
superior vs. temporal
45 vs 90 degrees
110 vs 130 microns
Outcomes
Primary Outcome Measures
To evaluate the effect of hinge position (superior vs. temporal) , hinge width (45 vs. 90 degrees), and flap thickness on corneal sensation and dry eye after IntraLase LASIK.
Secondary Outcome Measures
Full Information
NCT ID
NCT00803478
First Posted
December 4, 2008
Last Updated
February 1, 2016
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT00803478
Brief Title
The Effect of Hinge Position and Hinge Width on Corneal Sensation and Dry Eye After IntraLase LASIK Procedure
Acronym
IDES
Official Title
The Effect of Hinge Position and Hinge Width on Corneal Sensation and Dry Eye After IntraLase LASIK Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Withdrawn
Study Start Date
June 2004 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Corneal sensation is known to play a role in tear secretion. Decreased sensation leads to decreased tear production; and when bilateral, leads to a decreased blink rate as well. Dry eyes are a common side effect of LASIK. Incidence rates vary widely, but have been reported in as many as 59% of patients. And almost all patients have some transient dry eye symptoms immediately following LASIK.
Previous studies have looked at the effect of hinge position (superior vs. nasal) and hinge width on corneal sensation and dry eye after LASIK performed with a mechanical microkeratome. Corneal sensation was decreased and dry eye signs and symptoms increased immediately following LASIK in all eyes. These parameters then improved at all time periods between 1 week and 6 months post-operative. Loss of corneal sensation and dry eye signs and symptoms were greater in eyes with superior-hinge flap than nasal-hinge flap, and in eyes with narrower hinge flap rather than wider hinge flap IntraLase LASIK, using the IntraLase femtosecond laser rather than a mechanical microkeratome to cut the corneal flap, has become an increasingly popular procedure. It provides several advantages over mechanical microkeratomes, including reduced surgical complications, more predictable flap thickness, better astigmatic neutrality, decreased epithelial injury, and an ability to operate on a wider range of patients.
The investigators propose this study to evaluate the effect of flap hinge size and flap thickness in corneal flaps created with the IntraLase laser. The investigators would like to determine if there is a difference from the previously discussed results found when using the mechanical microkeratome. Also, with the increased ease of programming alternate hinge width or flap thickness with IntraLase, if the investigators find a significant difference with an alternate flap configuration, it might translate to a feasible change in clinical practice.
Detailed Description
Corneal innervation/sensation is supplied by the long ciliary nerves which branch from the trigeminal nerve. The nerves enter the cornea in the mid-stroma at the nasal and temporal limbus. They then branch and turn anterior to form a dense plexus sub-Bowman's layer. The nerves finally terminate in the wing cell layer from where they enervate the epithelium. Corneal sensation has been shown to be decreased after all corneal surgeries, including LASIK.
Corneal sensation is known to play a role in tear secretion. Decreased sensation leads to decreased tear production; and when bilateral, leads to a decreased blink rate as well. Dry eyes are a common side effect of LASIK. Incidence rates vary widely, but have been reported in as many as 59% of patients. And almost all patients have some transient dry eye symptoms immediately following LASIK.
Previous studies have looked at the effect of hinge position (superior vs. nasal) and hinge width on corneal sensation and dry eye after LASIK performed with a mechanical microkeratome.1,2 Corneal sensation was decreased and dry eye signs and symptoms increased immediately following LASIK in all eyes. These parameters then improved at all time periods between 1 week and 6 months post-operative. Loss of corneal sensation and dry eye signs and symptoms were greater in eyes with superior-hinge flap than nasal-hinge flap, and in eyes with narrower hinge flap rather than wider hinge flap IntraLase LASIK, using the IntraLase femtosecond laser rather than a mechanical microkeratome to cut the corneal flap, has become an increasingly popular procedure. It provides several advantages over mechanical microkeratomes, including reduced surgical complications, more predictable flap thickness, better astigmatic neutrality, decreased epithelial injury,3 and an ability to operate on a wider range of patients.
We propose this study to evaluate the effect of flap hinge position and size in corneal flaps created with the IntraLase laser. We would like to determine if there is a difference from the previously discussed results found when using the mechanical microkeratome. Also, with the increased ease of programming alternate hinge position and width with IntraLase, if we find a significant difference with an alternate flap configuration, it might translate to a feasible change in clinical practice.
Specific Aims: To evaluate the effect of hinge position (superior vs. temporal) , hinge width (45 vs. 90 degrees), and flap thickness on corneal sensation and dry eye after IntraLase LASIK.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
IntraLase LASIK for primary myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hinge position
Arm Type
Active Comparator
Arm Description
superior vs. temporal
Arm Title
Hinge width
Arm Type
Active Comparator
Arm Description
45 vs 90 degrees
Arm Title
Flap Thickness
Arm Type
Active Comparator
Arm Description
110 vs 130 microns
Intervention Type
Procedure
Intervention Name(s)
LASIK
Primary Outcome Measure Information:
Title
To evaluate the effect of hinge position (superior vs. temporal) , hinge width (45 vs. 90 degrees), and flap thickness on corneal sensation and dry eye after IntraLase LASIK.
Time Frame
pre operative and 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Refractive error: Myopia < 12 D, with astigmatism < 3 D,
Age > 20 y/o
Regular corneal curvature, sufficient corneal thickness, appropriate pupil size, normal slit lamp examination
Informed consent to permit us to use their records for this study without using name, medical record number, or date of surgery.
Exclusion Criteria:
Pregnant/nursing
Systemic collagen vascular disease
Autoimmune disease
Severe dry eyes
Facility Information:
Facility Name
Cornea Clinic, Kellogg Eye Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of Hinge Position and Hinge Width on Corneal Sensation and Dry Eye After IntraLase LASIK Procedure
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