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OpenTrials
Completed

NCT Number: NCT03364322

Influencing Factors on Dry Eye Syndrome and Ocular Surface Disease

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.

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases Ocular Surface Disease

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kangnam Sacred Heart Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observation

Other

Observation

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hallym University Kangnam Sacred Heart Hospital

Other

Registry information

Official study title

Prospective Study for Influencing Factors on Dry Eye Syndrome, Ocular Surface Disease and Treatment

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 6, 2017
Registry last updated
Dec 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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