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Influencing Factors on Dry Eye Syndrome and Ocular Surface Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03364322
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Young Joo Shin, Hallym University Kangnam Sacred Heart Hospital

Study Description
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Brief Summary:
Dry eye syndrome and ocular surface disease are very important ophthalmologic diseases. It is known that various inducers are involved. However, it is still necessary to study how influencing factors are related to dry eye syndrome and ocular surface disease and how treatment for dry eye syndrome and ocular surface disease is helpful.

Condition or disease Intervention/treatment
Dry Eye Syndrome Ocular Surface Disease Other: Observation

Study Design
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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study for Influencing Factors on Dry Eye Syndrome, Ocular Surface Disease and Treatment
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017
Groups and Cohorts
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Group/Cohort Intervention/treatment
Dry eye syndrome Other: Observation
Observation


Outcome Measures
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Primary Outcome Measures :
  1. Ocular surface disease index [ Time Frame: 1 day ]
    The ocular surface disease index survey in completed at the time of the exam. This scale ranges from 0 to 100 higher scores representing greater disability.


Secondary Outcome Measures :
  1. Tear break-up time [ Time Frame: 1 day ]
  2. Schirmer tear secretion test [ Time Frame: 1 day ]
    Schirmer tear secretion test (mm) without anesthesia was performed using strip (Color Bar; Eagle vision. Memphis, TN)

  3. Corneal fluorescence staining [ Time Frame: 1 day ]
    Corneal staining with fluorescein solution is graded at the time of the exam on a scale of 0 to 5 using the oxford scoring system with 5 being the most severe staining.


Other Outcome Measures:
  1. Tear osmolarity [ Time Frame: 1 day ]
    The tear film osmolarity (mOsm) is measured using TearLab (TearLab Co., San Diego, CA).

  2. Eyelid hyperemia [ Time Frame: 1 day ]
    Graded as follows. 0=none, 1= mild, 2=mod, and 3=severe

  3. Conjunctivochalasis [ Time Frame: 1 day ]
    Graded as follows. 0=none, 1= mild, 2=mod, and 3=severe fixed fold

  4. visual analogue pain score [ Time Frame: 1 day ]
    visual analogue pain score indicates a higher level of discomfort. 0 to 10.

  5. modification of SPEED score [ Time Frame: 1 day ]
    SPEED score using questionnaire indicates a higher level of discomfort.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with ocular discomfort related to DED who visit the Hallym University Kangnam Sacred Heart Hospital between June 2016 and June 2017.
Criteria

Inclusion Criteria:

  • Patients with ocular discomfort related to DED who visit the Hallym University Kangnam Sacred Heart Hospital between June 2016 and June 2017.

Exclusion Criteria:

  • Subjects who are elderly (≥80 years old) or have an autoimmune disease (e.g., Sjögren's syndrome and systemic lupus erythematosus) are excluded.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364322


Locations
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Korea, Republic of
Kangnam Sacred Heart Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Hallym University Kangnam Sacred Heart Hospital
More Information
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Responsible Party: Young Joo Shin, Principal Investigator, Hallym University Kangnam Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT03364322    
Other Study ID Numbers: 2016-06-73
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Syndrome
Disease
Pathologic Processes
Lacrimal Apparatus Diseases
 Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases