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

July 17, 2020 updated by: Al-Rasheed University College
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
    • AL-Adhmia
      • Baghdad, AL-Adhmia, Iraq, 12221
        • Al-Rasheed University College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: FS-LASIK Group
100 eyes of 50 patients underwent bilateral FS-LASIK (Femtosecond laser Insitu Keratomileusis)
Procedure: S-LASIK
Femtosecond laser Insitu keratomileusis
EXPERIMENTAL: FS-SMILE
100 eyes of 50 patients who underwent bilateral FS-SMILE (femtosecond small incision lenticule extraction)
Procedure: FS-SMILE
Femtosecond small incision lenticule extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Surface Disease Index
Time Frame: After 1 month of surgery
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
Time Frame: After 6 months of surgery
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
Time Frame: After 1 month of surgery
Tear Break-Up Time (in seconds)
After 1 month of surgery
Tear Break-Up Time
Time Frame: After 6 months of surgery
Tear Break-Up Time (in seconds)
After 6 months of surgery
Schirmer I test
Time Frame: After 1 month of surgery
Schirmer I test (in mm/5 minutes)
After 1 month of surgery
Schirmer I test
Time Frame: After 6 months of surgery
Schirmer I test (in mm/5 minutes)
After 6 months of surgery
Oxford score
Time Frame: After 1 month of surgery
Oxford score (the score range from 0 to 5), higher value indicate more severe disease
After 1 month of surgery
Oxford score
Time Frame: After 6 months of surgery
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
Time Frame: After 1 month of surgery
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
Time Frame: After 6 months of surgery
Dry Eye Work Shop scale (value range from 0 to 4), higher value indicate more severe disease
After 6 months of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Rasheed University College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2017

Primary Completion (ACTUAL)

October 31, 2018

Study Completion (ACTUAL)

October 31, 2018

Study Registration Dates

First Submitted

July 14, 2020

First Submitted That Met QC Criteria

July 17, 2020

First Posted (ACTUAL)

July 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2020

Last Update Submitted That Met QC Criteria

July 17, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR200106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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