Investigating Abnormal Lipid Layer Thickness and Other Objective Dry Eye Parameters in Patients Seeking Blepharoplasty, and How They Change After Blepharoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Lipid layer thickness
研究概览
简要总结
Deficiency in tear film lipid layer thickness (LLT) has been implicated in the development of dry eye symptoms, and is influenced to a significant degree by the anatomy and function of the eyelids. Patients who are considering blepharoplasty, even if it is for cosmetic reasons, may subtle differences in eyelid anatomy that pre-dispose them to having an abnormal tear lipid layer. Moreover, the changes in anatomy and contour of the eyelids following blepharoplasty introduce a whole new group of factors, such as an altered palpebral aperture and altered canthal fixation that can further change the eyelid's ability to maintain a healthy tear lipid layer, for better or for worse. Such changes in tear lipid layer can be detected with the aid of a newly acquired tear interferometer (LipiView, Tearscience Inc.), but has never been done in the context of blepharoplasty management. Due to the strong association between LLT and risk of dry eyes, we hope to investigate if there are significant differences in LLT and other objective dry eye parameters in two situations: 1) patients considering blepharoplasty as compared to other patients not considering such procedures 2) patients before and after undergoing blepharoplasty. The results of these investigations can go towards establishing LLT as an important objective parameter to account for before and after blepharoplasty.
详细描述
Study Objectives and Purpose
- By cross-sectional analysis, determine if there are significant differences in average and SD of LLT in a group of patients who are considering blepharoplasty (cases) as compared to a group of patients from a general ophthalmology clinic who have no lid disturbances (controls).
2a. Via a prospective study, determine the average and standard deviation of LLT in a group of patients undergoing blepharoplasty, and how these change in a one month period after surgery.
2b. Identify, through the same prospective study, if factors such as age and gender are associated with the direction and magnitude of changes in LLT.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteers that are medically fit and willing to participate in this study.
- •Volunteers who fit the criteria mentioned previously in the experimental design.
排除标准
- •Patients who are about to undergo cosmetic blepharoplasty.
- •Patients with other ocular surgeries pre-blepharoplasty that may have disturbed the ocular surface e.g. cataract phacoemulsification, pterygium removal.
- •Patients who experience major post-surgery side effects or complications unrelated to DES will be excluded from the study.
- •Patients with history of Parkinson's disease and other neurogenic conditions which interfere with blink rate.
- •Patients with proptosis or exophthalmos due to congenital reasons or Thyroid Eye Disease.
- •Patients who are on anti-histamine drugs.
结局指标
主要结局
Lipid layer thickness
时间窗: 1 month
Tear interferometry is non-invasive and is not unlike a standard slit-lamp examination of the eye. Patients will be asked to rest their chin on a chinrest and direct their sight at a single white-light source for 30 seconds. The same process will be repeated for another 30 seconds with the other eye. During this time, they are encouraged to blink at their comfortable pace. It is extremely safe and does not require contact of the ocular surface in any way.
次要结局
- Tear break up time(1 month)
- Fluorescein Dye Corneal Staining(1 month)
研究者
Louis Tong
Clinician-Scientist, Senior Consultant
Singapore National Eye Centre