The Proportion of Patients Diagnosed With Dry Eye by the Asia Dry Eye Society (ADES) Criteria in Taiwan (DECS-TW)

Study Overview
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Brief Summary
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The study aims to determine the proportion of patients diagnosed with dry eye by the Asia Dry Eye Society (ADES) criteria, among patients diagnosed with dry eye disease under current hospital-based practice in Taiwan.

Detailed Description
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This real-world, observational study aims to show in a descriptive manner to characterize the patient profile of dry eye disease in Taiwan, and to understand the local practice and its difference compared with Asia Dry Eye Society (ADES) criteria. Specific objectives include:(1) to determine the proportion of patients diagnosed with dry eye by the Asia Dry Eye Society (ADES) criteria, among patients diagnosed with dry eye disease under current hospital-based practice in Taiwan, (2) to compare the patient profile including ocular condition and dry eye-related characteristics of dry eye diagnosed with ADES criteria versus hospital-based real-world practice in Taiwan, and (3) to determine the disease characteristics of patients diagnosed with dry eye in Taiwan medical institutions. This study will enroll patients who are diagnosed with dry eye, aged 20 years (inclusive), and are willing to provide signed informed consent. These patients will be categorized into Group I or II according to the inclusion criteria. Clinical data of eligible patients at the time of dry eye diagnosis on medical charts will be collected. If any return visit is scheduled per routine practice before the end of data collection (Feb-28-2022), follow-up data regarding dry eye evaluations and treatments will be collected at the first follow-up visit for Group I; and within 6 months after the cataract surgery for Group II.

Official Title
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Dry Eye Cross-Sectional Study-Taiwan (DECS-TW): Observational, Multicenter, Cross-Sectional Study on Dry Eye Disease in Taiwan

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who meet the criteria of either Group I OR Group II are eligible. Group I Patients with signed informed consent and who satisfy all of the following criteria will be included: 20 years old or older (regardless of sex) Outpatients Newly-diagnosed with dry eye disease (DED) within 6 months prior to signing the informed consent under hospital-based practice in Taiwan Group II Patients with signed informed consent and who satisfy all of the following criteria will be included: 20 years old or older (regardless of sex) Outpatients Patients who had undergone cataract surgery and was suspected to have dry eye disease (dry eye evaluations conducted based on the routine practice) within 6 months prior to signing the informed consent or was diagnosed with dry eye disease within 6 months prior to signing the informed consent Exclusion Criteria: Patients who meet ANY one of the following criteria are not eligible. Patients who have ocular comorbidities, and appear dry eye sign and symptoms that interfere with diagnosis of dry eye disease (DED) Patients who cannot confirm subjective symptoms of dry eye Patients who cannot read or write, and/or could not understand dry eye questionnaire appropriately which may compromise the accuracy of questionnaire score. Patients who participate in other interventional trials in the past 30 days

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br>20 years old or older (regardless of sex) Outpatients Newly-diagnosed with dry eye disease (DED) within 6 months prior to signing the informed consent under hospital-based practice in Taiwan | Other: No intervention<br>* No intervention will be applied for the observational study.<br>|
| Group II<br>20 years old or older (regardless of sex) Outpatients Patients who had undergone cataract surgery and was suspected to have dry eye disease (dry eye evaluations conducted based on the routine practice) within 6 months prior to signing the informed consent or was diagnosed with dry eye disease within 6 months prior to signing the informed consent | Other: No intervention<br>* No intervention will be applied for the observational study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who satisfy the criteria for dry eye disease based on the ADES criteria | The criteria are defined by Asia Dry Eye Society (ADES). | At the time of dry eye diagnosis (baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients per dry eye severity | Dry eye severity (mild, moderate, severe) is judged by the investigator. | From baseline to 6-month follow-up | 
| Proportion of patients per dry eye classification | Dry eye classification is judged by the investigator. | From baseline to 6-month follow-up | 
| Length (mm) of soaked strip by tear for the dry eye diagnosis | Unanesthetized Schirmer's test is used for assessing the tear production. | From baseline to 6-month follow-up | 
| Time (second) for tear film broken with fluorescein for the dry eye diagnosis | Tear break-up time (TBUT) is used to assess for tear film (evaporative dry eye disease). | From baseline to 6-month follow-up | 
| Score of Ocular Surface Disease Index (OSDI) for the dry eye symptoms | Ocular Surface Disease Index (OSDI) questionnaire (0 to 100 points) is used to assess the dry eye symptoms. One hundred points mean that the dry eye disease of the patient is severe. | From baseline to 6-month follow-up | 
| Score of Standard Patient Evaluation of Eye Dryness (SPEED) for the dry eye symptoms | Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire (0 to 28 points) is used to assess the dry eye symptoms. Twenty-eight points mean that the symptoms of dry eye disease is severe. | From baseline to 6-month follow-up | 
| Visual analogue scale (VAS) for the dry eye severity | Visual analogue scale (VAS) (0 to 10 [mild to severe]) is used to assess the dry eye severity based on the symptoms. | From baseline to 6-month follow-up | 
| Difference in length (mm) of soaked strip by tear between patients who satisfy the criteria for dry eye disease based on the ADES consensus report and the whole population (i.e., hospital-based real-world practice) | Unanesthetized Schirmer's test is used for assessing the tear production. | At the time of dry eye diagnosis (baseline) | 
| Difference in time (second) for tear film broken with fluorescein between patients who satisfy the criteria for dry eye disease based on the ADES consensus report and the whole population (i.e., hospital-based real-world practice) | Tear break-up time (TBUT) is used to assess for tear film (evaporative dry eye disease). | At the time of dry eye diagnosis (baseline) | 
| Difference in score of Ocular Surface Disease Index (OSDI) between patients who satisfy the criteria for dry eye disease based on the ADES consensus report and the whole population (i.e., hospital-based real-world practice) | Ocular Surface Disease Index (OSDI) questionnaire (0 to 100 points) is used to assess the dry eye symptoms. One hundred points mean that the dry eye disease of the patient is severe. | At the time of dry eye diagnosis (baseline) | 
| Difference in score of Standard Patient Evaluation of Eye Dryness (SPEED) between patients who satisfy the criteria for dry eye disease based on the ADES consensus report and the whole population (i.e., hospital-based real-world practice) | Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire (0 to 28 points) is used to assess the dry eye symptoms. Twenty-eight points mean that the symptoms of dry eye disease is severe. | At the time of dry eye diagnosis (baseline) | 
| Difference in visual analogue scale (VAS) between patients who satisfy the criteria for dry eye disease based on the ADES consensus report and the whole population (i.e., hospital-based real-world practice) | Visual analogue scale (VAS) (0 to 10 [mild to severe]) is used to assess the dry eye severity based on symptoms. | At the time of dry eye diagnosis (baseline) | 
| Proportion of patients who do not satisfy the criteria for dry eye disease based on the ADES per dry eye severity | Dry eye severity (mild, moderate, severe) is judged by the investigator. | From baseline to 6-month follow-up | 
| Proportion of patients who do not satisfy the criteria for dry eye disease based on the ADES per dry eye classification | Dry eye classification is judged by the investigator. | From baseline to 6-month follow-up | 
| Length (mm) of soaked strip by tear using unanesthetized Schirmer test of patients who do not satisfy the criteria for dry eye disease based on the ADES | Schirmer's test is used for assessing the tear production. | From baseline to 6-month follow-up | 
| Time (second) for tear film broken with fluorescein of patients who do not satisfy the criteria for dry eye disease based on the ADES | Tear break-up time (TBUT) is used to assess for tear film (evaporative dry eye disease). | From baseline to 6-month follow-up | 
| Score of Ocular Surface Disease Index (OSDI) of patients who do not satisfy the criteria for dry eye disease based on the ADES | Ocular Surface Disease Index (OSDI) questionnaire (0 to 100 points) is used to assess the dry eye symptoms. One hundred points mean that the dry eye disease of the patient is severe. | From baseline to 6-month follow-up | 
| Score of Standard Patient Evaluation of Eye Dryness (SPEED) of patients who do not satisfy the criteria for dry eye disease based on the ADES | Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire (0 to 28 points) is used to assess the dry eye symptoms. Twenty-eight points mean that the symptoms of dry eye disease is severe. | From baseline to 6-month follow-up | 
| Visual analogue scale (VAS) of patients who do not satisfy the criteria for dry eye disease based on the ADES | Visual analogue scale (VAS) (0 to 10 [mild to severe]) is used to assess the dry eye severity based on the symptoms. | From baseline to 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye disease, Asia Dry Eye Society (ADES) criteria, Taiwanese population