Nearsightedness (myopia) Eye Diseases Myopia
Conditions
Interventions
In femtosecond (FS) group, the 60 KHz IntraLase femtosecond laser (Abbott Medical Optics, Inc.) was preprogrammed for each procedure with a planned flap diameter of 9.0 millimeter (mm), flap thickness
Sponsors
Chang Gung Memorial Hospital (Taiwan)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corneal Sensation: 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
| Measure | Time frame |
|---|---|
| 1. Schirmer?s Basic Tear Secretion Test Five minutes after installing a drop of proparacaine 1% into the conjunctival sac and drying the fornix, a sterile standardised Schirmer Tear Test Strip (Alcon Laboratories) was placed in both inferior fornices at the junction of the lateral and middle third for another 5 minutes. The strip wetting was measured and recorded in millimeters. 2. Tear Breakup Time The fluorescein tear breakup time was evaluated 2 minutes after the inferotemporal bulbar conjunctiva was touched with a sodium fluorescein strip (Fluor-I-strip; Bausch & Lomb Pharmaceuticals Inc, Tampa, Florida). All patients were instructed to blink and the pre-corneal tear film was examined under blue-light illumination with a slit lamp. The time interval (seconds) from the last blink to the first area of breakup was recorded. Three separate readings were taken for each eye and the results were averaged. 3. Ocular Surface Staining The conjunctival and corneal staining measurements were graded from 0 (none) to 3 (severe) based on the amount of staining. The cornea evaluated by fluorescein strips was divided into the central cornea, the superior, inferior, nasal, and temporal quadrants. Rose bengal staining was graded for cornea and each quadrants of superior, inferior, nasal, and temporal conjunctiva. The range of staining scores was from 0 to 15. 4. Ocular Surface Disease Index The Ocular Surface Disease Index (OSDI) was developed by the Outcomes Research Group (Allergan) and consists of a 12-item questionnaire designed to assess the symptoms of ocular irritation consistent with dry-eye disease and their impact on vision-related functioning. The questions are divided into 3 categories including vision-related function, ocular symptoms and environmental triggers. The grading of the OSDI is from 0 to 4, where 0 indicates none of the time; 1, some of the time; 2, half of the time; 3, most of the time; and 4, all of the time. The total OSDI score was calculated on the bas | — |
Countries
Taiwan
Outcome results
None listed