Comparison of dry eye syndrome and corneal sensation after femtosecond- and microkeratome-assisted LASIK

Completed

Conditions: Eye Diseases
Myopia
earsightedness (myopia)

Registration Number: ISRCTN43661922

Lead Sponsor: Chang Gung Memorial Hospital (Taiwan)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 200

Inclusion Criteria

1. Patients of both sexes with low to moderate myopia (< -6.00 diopetrs, D) with or without astigmatism up to ?3.00 D after informed consent
2. A minimum age of 18 and younger than 35 years, a normal ophthalmic examination except for refractive error and a stable refraction
3. A minimum calculated residual corneal stromal bed thickness greater than 250 µm

Exclusion Criteria

1. Patients with keratoconus, severe dry eyes, herpetic eye diseases or other cornal diseases
2. Patients with active collagen vascular disease, autoimmune disorders
3. Pregnant or breast feeding
4. Patients with severe abnormal curvature of the cornea (more than 47D / less than 38-41D)
5. Patients with acute or subacute uveitis
6. Patients with unrealistic expectations

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Corneal Sensation:<br>Corneal sensitivity was measured with a Cochet-Bonnet esthesiometer (Luneau Ophtalmologie, Chartres Cedex, France) (Macri A and Pflugfelder SC, 2000) consisting of a 60.0 mm adjustable nylon monofilament. The filament is soft when fully extended and becomes firm when retracted into the handpiece, creating a pressure gradient that ranges from 11 to 200 milligram(mg)/mm2. Patients were asked to look straight ahead and to indicate when the top of nylon filament was felt to touch the cornea. The measurement was started at 60.0 mm and the length of the filament was decreased by 5.0 mm increments to increase its rigidity. The corneal sensitivity was defined as the length of the filament that produced a first positive response. The higher the number obtained, the more sensitive the cornea.

Secondary Outcome Measures