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

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04477421
• Other study ID #: AR200106
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: July 2020
• Source: Al-Rasheed University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Procedure:
• FS-SMILE
Femtosecond small incision lenticule extraction
• S-LASIK
Femtosecond laser Insitu keratomileusis

Locations

Country	Name	City	State
Iraq	Al-Rasheed University College	Baghdad	AL-Adhmia

Sponsors (1)

Lead Sponsor	Collaborator
Al-Rasheed University College

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Tear Break-Up Time	Tear Break-Up Time (in seconds)	After 1 month of surgery
Primary	Tear Break-Up Time	Tear Break-Up Time (in seconds)	After 6 months of surgery
Primary	Schirmer I test	Schirmer I test (in mm/5 minutes)	After 1 month of surgery
Primary	Schirmer I test	Schirmer I test (in mm/5 minutes)	After 6 months of surgery
Primary	Oxford score	Oxford score (the score range from 0 to 5), higher value indicate more severe disease	After 1 month of surgery
Primary	Oxford score	Oxford score (the score range from 0 to 5), higher value indicate more severe disease	After 6 months of surgery
Primary	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
Primary	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