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

Not Applicable

Completed

• Conditions: Dry Eye Disease
• Interventions: Procedure: FS-SMILE; Procedure: S-LASIK

• 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

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Status Verified: 2020-07
• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-17
• Last Update Submitted: 2020-07-17
• Study First Posted: 2020-07-20
• Last Update Posted: 2020-07-20

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

Arm && Interventions

Group	Intervention	Description
FS-SMILE	FS-SMILE	100 eyes of 50 patients who underwent bilateral FS-SMILE (femtosecond small incision lenticule extraction)
FS-LASIK Group	S-LASIK	100 eyes of 50 patients underwent bilateral FS-LASIK (Femtosecond laser Insitu Keratomileusis)

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

Trial Locations

Locations (1)

Al-Rasheed University College; 🇮🇶 Baghdad, AL-Adhmia, Iraq