Non-invasive Ocular Surface Measurements Before and After Interventions
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Dry Eye Syndrome
- 发起方
- University of Rochester
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in Ocular Surface Temperature (OST)
- 状态
- 终止
- 最后更新
- 10年前
概览
简要总结
Objectively evaluate the ocular surface (pre-corneal tear film) of individuals prior to and after an intervention (such as a dry eye treatment, environmental change, artificial tear use, or contact lens wear) in a controlled-environmental chamber, over time using non-contact instruments.
详细描述
Most studies will set the environmental conditions (temperature, humidity, airflow) to mimic typical office and home environments (68 to 72F and 20 to 50%). For condition change studies, the chamber will operate between 65 and 85F and 25% and 80% RH with air flow turned off or set to a maximum of 3-4 m/s. For this type of study we will have the subject acclimate to a set of environmental conditions (approximately 20 minutes) and take a set of measurements. Then we will change the conditions (rate of change is 3F/hour and 3% RH/hour), have the subject acclimate to these conditions (later on the same day or on another day) and take another set of measurements. The expected study length is approximately two hours for a single visit.
研究者
James V. Aquavella, MD
Principal Investigator
University of Rochester
入排标准
入选标准
- •Individuals with dry eye diagnoses (aqueous deficient dry eye \[ADDE\], and/or evaporative dry eye), dry eye symptoms (as associated with Sjogren's Syndrome diagnosis), refractive surgery, contact lens use, and exposure to dry work environments are appropriate to correlate clinical tests, subjective responses and objective measurements of current ocular surface status and to study clinically-recommended or patient-directed dry eye treatments such as taking dietary supplements, wearing moisture-retaining goggles, performing lid massage, or using over the counter eye drops or artificial tears.
- •Individuals who do not currently have dry eye symptoms but who may be at risk for dry eye diagnosis, and those who have dry eye symptoms but no clinical dry eye diagnosis, are of interest to correlate clinical tests, subjective responses and objective measurements of current ocular surface status and, if symptoms appear or worsen, to correlate the data with the effect of environmental condition changes, such as increasing the humidity or reducing air flow, on the ocular surface.
- •Individuals who have undergone ocular surgery are at increased risk for dry eye. While some subjects who have had ocular surgery may never develop dry eye symptoms because they have an adequate reserve of tear production, others may develop symptoms as a result of the disruption of the ocular surface, including the anatomy and nerves. Subjects who have had surgery or procedures and are no longer being provided with direct post-operative care may participate in the study. Routine follow-up post- operative care does not disqualify subjects from participation. Subjects who are receiving post-operative care must obtain approval of their clinician to participate in the study.
- •Individuals who have eye conditions that affect the shape or condition of the cornea, such as individuals with keratoconus.
- •Experienced contact lens wearers are appropriate for studies that use their own lenses (soft, rigid gas permeable \[RGP\], hard \[PMMA\]) or the same type of lens within the FDA approved modality (daily, continuous or extended wear) and replacement cycle (for example, daily, one week, one month, etc.) as described in the lens package insert and/or prescribed by their eye care provider to investigate ocular surface data before, during and after lens use.
- •Normal individuals, those without a dry eye diagnosis, without dry eye symptoms or those who do not wear contacts to act as controls for the focus areas in the studies.
排除标准
- •Individuals with eye or medical condition(s) that contraindicate performing screening or measurements will not be eligible for this study. Specific examples include:
- •Individuals will not be dilated if an exam and/or medical history indicted they have a narrow anterior chamber angle, glaucoma, or other contraindications to dilation (like arterio-sclerotic cerebrovascular disease).
- •Individuals with the following will not participate in contact lens studies: presence of ocular or systemic allergies or disease (infection), clinically significant (grade 3 or 4) corneal edema, corneal vascularization, or any other abnormalities of the cornea, tarsal abnormalities or bulbar injection or use of medication that might interfere with contact lens wear.
- •Individuals will not participate in any aspect of the study if: they are pregnant or become pregnant or are lactating, have an infectious disease (e.g. hepatitis, tuberculosis) or have an immuno-suppressive disease (e.g. HIV).
- •Individuals with known sensitivity to dyes or to numbing drops will not be screened using these agents.
- •Individuals who wear dental braces cannot be involved in the measurements in which a dental impression/bite bar is required. The impression material will stick to the braces. Individuals with very sensitive teeth or loose dentures may have difficulty making the dental impression.
结局指标
主要结局
Change in Ocular Surface Temperature (OST)
时间窗: baseline and 30 minutes
Objectively evaluate the ocular surface temperature prior to and after 30 minutes of acclimation to three different environmental conditions in a controlled-environmental chamber using thermal imaging. 10 eyes were analyzed for each group.