Dry Eye Disease
Conditions
Brief summary
Comparison of femtosecond small incision lenticule extraction (FS-SMILE) versus Femtosecond laser Insitu Keratomileusis (FS-LASIK) regarding dry eye disease (DED) and corneal sensitivity (CS) after those refractive surgeries.
Interventions
PROCEDUREFS-SMILE
Femtosecond small incision lenticule extraction
PROCEDURES-LASIK
Femtosecond laser Insitu keratomileusis
Sponsors
Al-Rasheed University College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* bilateral eyes with spherical correction range from -2 to -6 diopters and cylinder range from 0 to - 3.5 diopters
Exclusion criteria
* sign or symptom of dry eye disease (tear film breakup time (TBUT) \>10 seconds * Schirmer I test \>10 mm /5 minutes) * corneal or conjunctival staining * Meibomian gland dysfunction * Previous ocular and or eyelid medical or surgical treatment * pregnancy * Chronic systemic disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Index | After 1 month of surgery | Ocular Surface Disease Index (the index range from 0 to 100), higher value indicate more severe disease |
| Tear Break-Up Time | After 1 month of surgery | Tear Break-Up Time (in seconds) |
| Schirmer I test | After 1 month of surgery | Schirmer I test (in mm/5 minutes) |
| Oxford score | After 1 month of surgery | Oxford score (the score range from 0 to 5), higher value indicate more severe disease |
| Dry Eye Work Shop scale | After 1 month of surgery | Dry Eye Work Shop scale (value range from 0 to 4), higher value indicate more severe disease |
Countries
Iraq
Outcome results
None listed