Clinical trial NCT05096546: The Proportion of Patients Diagnosed With Dry Eye by the Asia Dry Eye Society (ADES) Criteria in Taiwan (DECS-TW)
Official title: Dry Eye Cross-Sectional Study-Taiwan (DECS-TW): Observational, Multicenter, Cross-Sectional Study on Dry Eye Disease in Taiwan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dry Eye Syndromes
Keywords: Dry eye disease
Asia Dry Eye Society (ADES) criteria
Taiwanese population
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Santen Pharmaceutical (Taiwan) Co., LTD
name: Kaohsiung Medical University
name: Taipei Veterans General Hospital, Taiwan
First posted: 2021-10-27
Enrollment: 540
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: These patients will be screened in the outpatient department at Far Eastern Memorial Hospital, Kaohsiung Medical University Hospital, and Taipei Veteran General Hospital.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who satisfy the criteria for dry eye disease based on the ADES criteria
timeFrame: At the time of dry eye diagnosis (baseline)
Secondary outcomes:
measure: Proportion of patients per dry eye severity
timeFrame: From baseline to 6-month follow-up
measure: Proportion of patients per dry eye classification
timeFrame: From baseline to 6-month follow-up
measure: Length (mm) of soaked strip by tear for the dry eye diagnosis
timeFrame: From baseline to 6-month follow-up
measure: Time (second) for tear film broken with fluorescein for the dry eye diagnosis
timeFrame: From baseline to 6-month follow-up
measure: Score of Ocular Surface Disease Index (OSDI) for the dry eye symptoms
timeFrame: From baseline to 6-month follow-up
measure: Score of Standard Patient Evaluation of Eye Dryness (SPEED) for the dry eye symptoms
timeFrame: From baseline to 6-month follow-up
measure: Visual analogue scale (VAS) for the dry eye severity
timeFrame: From baseline to 6-month follow-up
measure: 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)
timeFrame: At the time of dry eye diagnosis (baseline)
measure: 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)
timeFrame: At the time of dry eye diagnosis (baseline)
measure: 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)
timeFrame: At the time of dry eye diagnosis (baseline)
measure: 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)
timeFrame: At the time of dry eye diagnosis (baseline)
measure: 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)
timeFrame: At the time of dry eye diagnosis (baseline)
measure: Proportion of patients who do not satisfy the criteria for dry eye disease based on the ADES per dry eye severity
timeFrame: From baseline to 6-month follow-up
measure: Proportion of patients who do not satisfy the criteria for dry eye disease based on the ADES per dry eye classification
timeFrame: From baseline to 6-month follow-up
measure: 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
timeFrame: From baseline to 6-month follow-up
measure: Time (second) for tear film broken with fluorescein of patients who do not satisfy the criteria for dry eye disease based on the ADES
timeFrame: From baseline to 6-month follow-up
measure: Score of Ocular Surface Disease Index (OSDI) of patients who do not satisfy the criteria for dry eye disease based on the ADES
timeFrame: From baseline to 6-month follow-up
measure: 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
timeFrame: From baseline to 6-month follow-up
measure: Visual analogue scale (VAS) of patients who do not satisfy the criteria for dry eye disease based on the ADES
timeFrame: From baseline to 6-month follow-up
Other outcomes:
Locations:
city: Kaohsiung city
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veteran General Hospital
Study officials:
References: