跳至主要内容
临床试验/NCT06443554
NCT06443554招募中不适用

Evaluation of the Effectiveness of a Community Health Management Program for Dry Eye Disease in Middle-Aged and Elderly Individuals

Fujian University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
182
试验地点
1
主要终点
Schirmer I Test

研究概览

简要总结

This study evaluates the effectiveness of a community health management program for middle-aged and elderly patients with dry eye disease (DED). By comparing the community-based health management plan with conventional treatment, the study aims to determine the impact on eye health and quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients meeting the diagnostic criteria for dry eye disease.
  • •Middle-aged and elderly individuals aged 45 years and above.
  • •Normal cognitive and expressive abilities.
  • •Informed consent and ability to complete the survey.
  • •Voluntary participation in the study.

排除标准

  • •Patients with other ocular surface diseases, including stye, trachoma, allergic conjunctivitis, etc.
  • •Patients with severe cataracts, glaucoma, uveitis, retinal detachment, optic nerve diseases, high myopia, or other conditions.
  • •Patients who have undergone eye surgery or have a history of eye trauma in the past three months.
  • •Patients who did not sign the informed consent form.

研究组 & 干预措施

Control group

Placebo Comparator

干预措施: Standard Treatment (Procedure)

Intervention group

Experimental

干预措施: Health Management Intervention Program (Procedure)

结局指标

主要结局

Schirmer I Test

时间窗: 12 weeks

The Schirmer I test measures tear secretion by placing a Schirmer strip under the lower eyelid conjunctiva with the patient's eyes closed, measuring tear absorption over 5 minutes. This test is widely used to evaluate dry eye syndrome. Tear secretion measured by Schirmer I test (without anesthesia) \>5 mm/5 min and ≤10 mm/5 min indicates mild dry eye; \>3 mm/5 min and ≤5 mm/5 min indicates moderate dry eye; and ≤3 mm/5 min indicates severe dry eye.

Goal Attainment Scaling (GAS)

时间窗: 12 weeks

GAS is an individualized assessment method encompassing multiple personal goals, with a standardized formula for calculating total scores to facilitate comparisons. A score of 50 represents the expected level of achievement, with higher scores indicating greater goal attainment. GAS demonstrates good reliability, validity, and sensitivity. Based on the GAS goal list, researchers and participants collaboratively select goals and assign weights. Expected goals (assigned 0 points) and other goal levels (significantly above expected +2, slightly above expected +1, slightly below expected -1, significantly below expected -2) are established. Goal attainment is evaluated during follow-up, and GAS scores are calculated.

Ocular Surface Disease Index (OSDI)

时间窗: 12 weeks

The OSDI questionnaire assesses common dry eye symptoms and their frequency, aiding in the grading of dry eye severity. It focuses on symptoms such as dryness, foreign body sensation, stinging, photophobia, blurred vision, and the impact on daily life and environmental factors. Symptoms are rated on a scale of frequency: always (4 points), most of the time (3 points), half of the time (2 points), occasionally (1 point), and never (0 points). The OSDI total score is calculated as (sum of item scores × 25)/12, ranging from 0 to 100, with higher scores indicating more severe symptoms.

Quality of Life for Dry Eye Patients

时间窗: 12 weeks

NEI-VFQ-25:This is one of the most commonly used ophthalmic quality of life questionnaires, assessing vision-related issues and patients' quality of life. It consists of 25 questions divided into three parts: general health and vision, limitations in activities, and responses to vision problems. The items are categorized into dimensions such as overall health, overall vision, eye pain, near activities, distance activities, peripheral vision, color vision, driving, social functioning, role limitations, dependency, and mental health. Respondents rate their subjective experience on a 5 or 6-point scale, with scores weighted according to the question type, using values such as 100, 75, 50, 25, 0, or not scored. The highest possible score is 100, and the lowest is 0. Scores for each dimension are averaged, and overall scores for each section are averaged from the dimension scores. Higher scores indicate better quality of life. 8.Diagnostic Criteria for Dry eye disease (DED).

次要结局

未报告次要终点

研究者

发起方
Fujian University of Traditional Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhang Shiyan

Director

Fujian University of Traditional Chinese Medicine

研究点 (1)

Loading locations...

相似试验

Evaluation of the Effectiveness of a Community... | 临床试验