Femtosecond Small Incision Lenticular Extraction in Comparison to Femtosecond Laser Insitu Keratomileusis Regarding Dry Eye Disease
Not Applicable
Completed
- Conditions
- Dry Eye Disease
- Registration Number
- NCT04477421
- Lead Sponsor
- Al-Rasheed University College
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Oxford score After 6 months of surgery Oxford score (the score range from 0 to 5), higher value indicate more severe disease
Schirmer I test After 6 months of surgery Schirmer I test (in mm/5 minutes)
Tear Break-Up Time After 6 months of surgery Tear Break-Up Time (in seconds)
Dry Eye Work Shop scale After 6 months of surgery Dry Eye Work Shop scale (value range from 0 to 4), higher value indicate more severe disease
Ocular Surface Disease Index After 6 months of surgery Ocular Surface Disease Index (the index range from 0 to 100), higher value indicate more severe disease
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Al-Rasheed University College
🇮🇶Baghdad, AL-Adhmia, Iraq
Al-Rasheed University College🇮🇶Baghdad, AL-Adhmia, Iraq