Femtosecond Small Incision Lenticular Extraction in Comparison to Femtosecond Laser Insitu Keratomileusis Regarding Dry Eye Disease

Study Overview
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Brief Summary
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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.

Official Title
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Femtosecond Small Incision Lenticular Extraction in Comparison to Femtosecond Laser Insitu Keratomileusis Regarding Dry Eye Disease

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Procedure: FS-SMILE
* Procedure: S-LASIK


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FS-LASIK Group<br>100 eyes of 50 patients underwent bilateral FS-LASIK (Femtosecond laser Insitu Keratomileusis) | Procedure: S-LASIK<br>* Femtosecond laser Insitu keratomileusis<br>|
| Experimental: FS-SMILE<br>100 eyes of 50 patients who underwent bilateral FS-SMILE (femtosecond small incision lenticule extraction) | Procedure: FS-SMILE<br>* Femtosecond small incision lenticule extraction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Disease Index | Ocular Surface Disease Index (the index range from 0 to 100), higher value indicate more severe disease | After 1 month of surgery | 
| Ocular Surface Disease Index | Ocular Surface Disease Index (the index range from 0 to 100), higher value indicate more severe disease | After 6 months of surgery | 
| Tear Break-Up Time | Tear Break-Up Time (in seconds) | After 1 month of surgery | 
| Tear Break-Up Time | Tear Break-Up Time (in seconds) | After 6 months of surgery | 
| Schirmer I test | Schirmer I test (in mm/5 minutes) | After 1 month of surgery | 
| Schirmer I test | Schirmer I test (in mm/5 minutes) | After 6 months of surgery | 
| Oxford score | Oxford score (the score range from 0 to 5), higher value indicate more severe disease | After 1 month of surgery | 
| Oxford score | Oxford score (the score range from 0 to 5), higher value indicate more severe disease | After 6 months of surgery | 
| Dry Eye Work Shop scale | Dry Eye Work Shop scale (value range from 0 to 4), higher value indicate more severe disease | After 1 month of surgery | 
| Dry Eye Work Shop scale | Dry Eye Work Shop scale (value range from 0 to 4), higher value indicate more severe disease | After 6 months of surgery |