Dry Eye Disease Clinical Trial
Official title:
Femtosecond Small Incision Lenticular Extraction in Comparison to Femtosecond Laser Insitu Keratomileusis Regarding Dry Eye Disease
NCT number | NCT04477421 |
Other study ID # | AR200106 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2017 |
Est. completion date | October 31, 2018 |
Verified date | July 2020 |
Source | Al-Rasheed University College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Iraq | Al-Rasheed University College | Baghdad | AL-Adhmia |
Lead Sponsor | Collaborator |
---|---|
Al-Rasheed University College |
Iraq,
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 |
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