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| Name | Class |
|---|---|
| Santen Pharmaceutical (Taiwan) Co., LTD | INDUSTRY |
| Kaohsiung Medical University | OTHER |
| Taipei Veterans General Hospital, Taiwan | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I |
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| Group II |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention will be applied for the observational study. |
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| 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) |
| 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 |
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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:
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
Exclusion Criteria:
Patients who meet ANY one of the following criteria are not eligible.
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These patients will be screened in the outpatient department at Far Eastern Memorial Hospital, Kaohsiung Medical University Hospital, and Taipei Veteran General Hospital.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Hospital | Kaohsiung City | Taiwan | ||||
| Far Eastern Memorial Hospital |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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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 |
| New Taipei City |
| Taiwan |
| Taipei Veteran General Hospital | Taipei | Taiwan |