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

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
FS-SMILE
S-LASIK
Sponsored by
Al-Rasheed University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Al-Rasheed University College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

FS-LASIK Group

FS-SMILE

Arm Description

100 eyes of 50 patients underwent bilateral FS-LASIK (Femtosecond laser Insitu Keratomileusis)

100 eyes of 50 patients who underwent bilateral FS-SMILE (femtosecond small incision lenticule extraction)

Outcomes

Primary Outcome Measures

Ocular Surface Disease Index
Ocular Surface Disease Index (the index range from 0 to 100), higher value indicate more severe disease
Ocular Surface Disease Index
Ocular Surface Disease Index (the index range from 0 to 100), higher value indicate more severe disease
Tear Break-Up Time
Tear Break-Up Time (in seconds)
Tear Break-Up Time
Tear Break-Up Time (in seconds)
Schirmer I test
Schirmer I test (in mm/5 minutes)
Schirmer I test
Schirmer I test (in mm/5 minutes)
Oxford score
Oxford score (the score range from 0 to 5), higher value indicate more severe disease
Oxford score
Oxford score (the score range from 0 to 5), higher value indicate more severe disease
Dry Eye Work Shop scale
Dry Eye Work Shop scale (value range from 0 to 4), higher value indicate more severe disease
Dry Eye Work Shop scale
Dry Eye Work Shop scale (value range from 0 to 4), higher value indicate more severe disease

Secondary Outcome Measures

Full Information

First Posted
July 14, 2020
Last Updated
July 17, 2020
Sponsor
Al-Rasheed University College
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1. Study Identification

Unique Protocol Identification Number
NCT04477421
Brief Title
Femtosecond Small Incision Lenticular Extraction in Comparison to Femtosecond Laser Insitu Keratomileusis Regarding Dry Eye Disease
Official Title
Femtosecond Small Incision Lenticular Extraction in Comparison to Femtosecond Laser Insitu Keratomileusis Regarding Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Al-Rasheed University College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FS-LASIK Group
Arm Type
Active Comparator
Arm Description
100 eyes of 50 patients underwent bilateral FS-LASIK (Femtosecond laser Insitu Keratomileusis)
Arm Title
FS-SMILE
Arm Type
Experimental
Arm Description
100 eyes of 50 patients who underwent bilateral FS-SMILE (femtosecond small incision lenticule extraction)
Intervention Type
Procedure
Intervention Name(s)
FS-SMILE
Intervention Description
Femtosecond small incision lenticule extraction
Intervention Type
Procedure
Intervention Name(s)
S-LASIK
Intervention Description
Femtosecond laser Insitu keratomileusis
Primary Outcome Measure Information:
Title
Ocular Surface Disease Index
Description
Ocular Surface Disease Index (the index range from 0 to 100), higher value indicate more severe disease
Time Frame
After 1 month of surgery
Title
Ocular Surface Disease Index
Description
Ocular Surface Disease Index (the index range from 0 to 100), higher value indicate more severe disease
Time Frame
After 6 months of surgery
Title
Tear Break-Up Time
Description
Tear Break-Up Time (in seconds)
Time Frame
After 1 month of surgery
Title
Tear Break-Up Time
Description
Tear Break-Up Time (in seconds)
Time Frame
After 6 months of surgery
Title
Schirmer I test
Description
Schirmer I test (in mm/5 minutes)
Time Frame
After 1 month of surgery
Title
Schirmer I test
Description
Schirmer I test (in mm/5 minutes)
Time Frame
After 6 months of surgery
Title
Oxford score
Description
Oxford score (the score range from 0 to 5), higher value indicate more severe disease
Time Frame
After 1 month of surgery
Title
Oxford score
Description
Oxford score (the score range from 0 to 5), higher value indicate more severe disease
Time Frame
After 6 months of surgery
Title
Dry Eye Work Shop scale
Description
Dry Eye Work Shop scale (value range from 0 to 4), higher value indicate more severe disease
Time Frame
After 1 month of surgery
Title
Dry Eye Work Shop scale
Description
Dry Eye Work Shop scale (value range from 0 to 4), higher value indicate more severe disease
Time Frame
After 6 months of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Al-Rasheed University College
City
Baghdad
State/Province
AL-Adhmia
ZIP/Postal Code
12221
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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