The Effect of Hinge Position and Hinge Width on Corneal Sensation and Dry Eye After IntraLase LASIK Procedure

NCT00803478 | Withdrawn

• 1 other identifier: HUM 18730-IDES
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

IntraLase LASIK for primary myopia

Outcome Measures

Primary Outcomes (1)

• 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.

  pre operative and 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months post-operative

Study Arms (3)

Hinge position

ACTIVE COMPARATOR

superior vs. temporal

Procedure: LASIK

Hinge width

ACTIVE COMPARATOR

45 vs 90 degrees

Procedure: LASIK

Flap Thickness

ACTIVE COMPARATOR

110 vs 130 microns

Procedure: LASIK

Interventions

LASIK PROCEDURE

Flap Thickness; Hinge position; Hinge width

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant/nursing
• Systemic collagen vascular disease
• Autoimmune disease
• Severe dry eyes

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Cornea Clinic, Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Myopia

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, Laser; Laser Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Keratectomy; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: erry J Bergstrom Collegiate Professor of Resident Education in Ophthalmology and Visual Sciences and Associate Professor of Oph, Ophthalmology & Visual Science

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: June 1, 2004
• Primary Completion: September 1, 2008
• Study Completion: December 1, 2015
• Last Updated: February 3, 2016

Record last verified: 2016-02

Locations

US (1)