The Effect of Hinge Position and Hinge Width on Corneal Sensation and Dry Eye After IntraLase LASIK Procedure
Public ClinicalTrials.gov record NCT00803478. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00803478
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- Not listed
Conditions and interventions
Eligibility (public fields only)
- Age range
- 20 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2004
- Primary completion
- Aug 31, 2008
- Completion
- Nov 30, 2015
- Last update posted
- Feb 2, 2016
2004 – 2015
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cornea Clinic, Kellogg Eye Center | Ann Arbor | Michigan | 48105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00803478, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 2, 2016 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00803478 live on ClinicalTrials.gov.