Femtosecond Small Incision Lenticular Extraction in Comparison to Femtosecond Laser Insitu Keratomileusis Regarding Dry Eye Disease
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2018
CompletedFirst Submitted
Initial submission to the registry
July 14, 2020
CompletedFirst Posted
Study publicly available on registry
July 20, 2020
CompletedJuly 20, 2020
July 1, 2020
1.7 years
July 14, 2020
July 17, 2020
Conditions
Outcome Measures
Primary Outcomes (10)
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
Study Arms (2)
FS-LASIK Group
ACTIVE COMPARATOR100 eyes of 50 patients underwent bilateral FS-LASIK (Femtosecond laser Insitu Keratomileusis)
FS-SMILE
EXPERIMENTAL100 eyes of 50 patients who underwent bilateral FS-SMILE (femtosecond small incision lenticule extraction)
Interventions
Eligibility Criteria
You may qualify if:
- bilateral eyes with spherical correction range from -2 to -6 diopters and cylinder range from 0 to - 3.5 diopters
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Al-Rasheed University College
Baghdad, AL-Adhmia, 12221, Iraq
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2020
First Posted
July 20, 2020
Study Start
March 1, 2017
Primary Completion
October 31, 2018
Study Completion
October 31, 2018
Last Updated
July 20, 2020
Record last verified: 2020-07