Non-invasive Tear Film Dynamic Measurements in Normal, MGD (Meibomium Gland Dysfunction) and Aqueous Deficient Dry Eye(ADDE) Subjects After Saline Instillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Visual Quality
研究概览
简要总结
Compare the objective tear film dynamic measurements in three different populations (MGD [Meibomium Gland Dysfunction], ADDE [Aqueous Deficient Dry Eye] and normal/control [non-dry eye]) and the subjective experience before and after instilling a single drop of saline in each eye.
Currently available office-based tests for dry eye do not reliably correlate with patients' subjective symptoms. This study is interested in assessing how individuals with these two different ocular surface diseases compare with the normal population when measured objectively using two different instruments.
详细描述
There will be one study day with a single visit that will consist of taking two sets of measurements. Baseline measurements are taken in both eyes using a wavefront sensor to measure visual quality followed by saline instillation. Five minutes after drops, visual quality is again measured to evaluate changes in tear dynamics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general Health
- •The subject must appear able and willing to adhere to the instructions set forth in this protocol (such as not use warm compresses or artificial tears/lubricant or excessive eye makeup before the visit on the study day).
排除标准
- •Ocular disease, infection or inflammation (allergy, blepharitis) that is clinically significant (grade 3 or 4) that in the opinion of the PI would not be a good subject.
- •Systemic disease or use of medication that in the opinion of the PI would not be a good subject.
- •Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
- •Contact lens wearer.
- •Pregnancy or lactation.
- •Diabetes.
- •Inclusion or exclusion criteria of the other cohorts.
- •Cohort Specific Inclusion Criteria:
- •ADDE cohort: Schirmer I < 10 mm, BUT ¬< 5 seconds, Fluorescein 0 or 1, currently using an artificial tear for ocular comfort at least occasionally.
- •MGD cohort: Diagnosis of moderate or severe MGD
- •Normal/Control (Non Dry-Eye): meets general inclusion and exclusion criteria
研究组 & 干预措施
Normal Patient Population
Non-Dry Eye patient population (intervention remains the same across all arms)
干预措施: Subjective Questionnaire (Behavioral)
Normal Patient Population
Non-Dry Eye patient population (intervention remains the same across all arms)
干预措施: Measurement with wavefront sensor (right eye, then left eye) (Procedure)
Normal Patient Population
Non-Dry Eye patient population (intervention remains the same across all arms)
干预措施: Instill Saline Drop (Drug)
MGD Patient Population
Meibomium Gland Dysfunction population(intervention remains the same across all arms)
干预措施: Subjective Questionnaire (Behavioral)
MGD Patient Population
Meibomium Gland Dysfunction population(intervention remains the same across all arms)
干预措施: Measurement with wavefront sensor (right eye, then left eye) (Procedure)
MGD Patient Population
Meibomium Gland Dysfunction population(intervention remains the same across all arms)
干预措施: Instill Saline Drop (Drug)
ADDE Population
Aqueous Deficient Dry Eye population(intervention remains the same across all arms)
干预措施: Subjective Questionnaire (Behavioral)
ADDE Population
Aqueous Deficient Dry Eye population(intervention remains the same across all arms)
干预措施: Measurement with wavefront sensor (right eye, then left eye) (Procedure)
ADDE Population
Aqueous Deficient Dry Eye population(intervention remains the same across all arms)
干预措施: Instill Saline Drop (Drug)
结局指标
主要结局
Visual Quality
时间窗: 5 seconds
Average visual quality change over a 5 second blink cycle caused by movement of the tears over the surface of the eye by measuring optical irregularities.
次要结局
未报告次要终点
研究者
James V. Aquavella, MD
Medical Doctor and Department Faculty
University of Rochester