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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

540 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-21

Study Completion Date

2022-07-31

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.

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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.

Conditions

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Dry Eye Syndromes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group I

1. 20 years old or older (regardless of sex)
2. Outpatients
3. Newly-diagnosed with dry eye disease (DED) within 6 months prior to signing the informed consent under hospital-based practice in Taiwan

No intervention

Intervention Type OTHER

No intervention will be applied for the observational study.

Group II

1. 20 years old or older (regardless of sex)
2. Outpatients
3. Patients who had undergone cataract surgery and

1. 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
2. was diagnosed with dry eye disease within 6 months prior to signing the informed consent

No intervention

Intervention Type OTHER

No intervention will be applied for the observational study.

Interventions

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No intervention

No intervention will be applied for the observational study.

Intervention Type OTHER

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:

1. 20 years old or older (regardless of sex)
2. Outpatients
3. 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:

1. 20 years old or older (regardless of sex)
2. Outpatients
3. Patients who had undergone cataract surgery and

1. 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
2. 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.

1. Patients who have ocular comorbidities, and appear dry eye sign and symptoms that interfere with diagnosis of dry eye disease (DED)
2. Patients who cannot confirm subjective symptoms of dry eye
3. Patients who cannot read or write, and/or could not understand dry eye questionnaire appropriately which may compromise the accuracy of questionnaire score.
4. Patients who participate in other interventional trials in the past 30 days

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No