Ocular Surface Disease in Glaucoma Patients on Long-Term Therapy
Prevalence and Severity of Ocular Surface Disease Among Adult Patients With Glaucoma on Long-Term Topical Antiglaucoma Medications
This cross-sectional study aims to determine the prevalence and severity of ocular surface disease among adult patients with glaucoma receiving long-term topical antiglaucoma medications.
研究概览
详细说明
Long-term use of topical antiglaucoma medications may adversely affect the ocular surface. This observational study will include adult patients with glaucoma who have been using one or more topical antiglaucoma medications for at least 6 months.
Participants will complete the Ocular Surface Disease Index (OSDI) questionnaire and undergo clinical ocular surface assessment including tear film break-up time, Schirmer I test, and corneal fluorescein staining.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Margo f Awad, Resident
- 电话号码：+20 12 73302611
- 邮箱：margo19.mahros@gmail.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Adult patients with diagnosed glaucoma receiving long-term topical antiglaucoma medications at Assiut University Hospital and El Mabarra Hospital.
描述
Inclusion Criteria:
- - Age 18 years or older
- Diagnosed glaucoma
- Currently receiving one or more topical antiglaucoma medications
- Duration of topical antiglaucoma treatment ≥6 months
- Written informed consent
Exclusion Criteria:
- - Current use of concomitant topical ocular medication that may affect the ocular surface (e.g., topical cyclosporine)
- Previous ocular surgery within the preceding 6 months
- History of corneal surgery or significant ocular trauma affecting the ocular surface
- Active ocular infection or significant active ocular inflammation
- Contact lens wear
- Systemic autoimmune or connective tissue diseases known to affect the ocular surface (e.g., Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus)
- Significant corneal pathology interfering with ocular surface assessment
学习计划
研究是如何设计的？
设计细节
- 观测模型：CASE_ONLY
- 时间观点：CROSS_SECTIONAL
队列和干预
团体/队列 |
|---|
|
Single cohort: Glaucoma patients on long-term topical therapy
Adult patients with glaucoma receiving topical antiglaucoma medications for at least 6 months who will undergo OSDI questionnaire and clinical ocular surface assessment. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Prevalence of ocular surface disease
大体时间：Baseline
|
Proportion of patients with ocular surface disease defined as an Ocular Surface Disease Index (OSDI) score ≥13. |
Baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of Patients with Mild Ocular Surface Disease Symptoms
大体时间：Baseline
|
Proportion of patients with mild ocular surface disease symptoms defined as OSDI score 13-22. |
Baseline
|
|
Proportion of Patients with Moderate Ocular Surface Disease Symptoms
大体时间：Baseline
|
Proportion of patients with moderate ocular surface disease symptoms defined as OSDI score 23-32. |
Baseline
|
|
Proportion of Patients with Severe Ocular Surface Disease Symptoms
大体时间：Baseline
|
Proportion of patients with severe ocular surface disease symptoms defined as OSDI score 33-100. |
Baseline
|
|
Mean OSDI score
大体时间：Baseline
|
Mean Ocular Surface Disease Index score (range 0-100). |
Baseline
|
|
Tear film break-up time (TBUT)
大体时间：Baseline
|
Mean tear film break-up time in seconds. |
Baseline
|
|
Schirmer I test result
大体时间：Baseline
|
Mean Schirmer I test value in millimeters. |
Baseline
|
|
Corneal fluorescein staining score
大体时间：Baseline
|
Mean total corneal fluorescein staining score (range 0-15) according to the NEI/Industry Workshop grading scale. |
Baseline
|
合作者和调查者
调查人员
- 学习椅：Mohamed s Abdel-rehim, prof、Ophthalmology Department, Assiut University Hospitals
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.