Influencing Factors on Dry Eye Syndrome and Ocular Surface Disease

December 5, 2017 updated by: Young Joo Shin, Hallym University Kangnam Sacred Heart Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

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

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

15 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dry eye syndrome
Other: Observation
Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tear break-up time
Time Frame: 1 day
1 day
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)
1 day
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.
1 day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tear osmolarity
Time Frame: 1 day
The tear film osmolarity (mOsm) is measured using TearLab (TearLab Co., San Diego, CA).
1 day
Eyelid hyperemia
Time Frame: 1 day
Graded as follows. 0=none, 1= mild, 2=mod, and 3=severe
1 day
Conjunctivochalasis
Time Frame: 1 day
Graded as follows. 0=none, 1= mild, 2=mod, and 3=severe fixed fold
1 day
visual analogue pain score
Time Frame: 1 day
visual analogue pain score indicates a higher level of discomfort. 0 to 10.
1 day
modification of SPEED score
Time Frame: 1 day
SPEED score using questionnaire indicates a higher level of discomfort.
1 day

Collaborators and Investigators

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

Sponsor

Hallym University Kangnam Sacred Heart Hospital

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)

June 1, 2016

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

November 25, 2017

First Submitted That Met QC Criteria

November 30, 2017

First Posted (Actual)

December 6, 2017

Study Record Updates

Last Update Posted (Actual)

December 7, 2017

Last Update Submitted That Met QC Criteria

December 5, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-06-73

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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