Protease and Cytokine Composition in Post Lens Tear Reservoir of Scleral Lenses for Keratoconic Eyes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Tear Protein
研究概览
简要总结
The purpose of this study is to investigate changes in the level of inflammatory mediators in the tear film of scleral contact lens wearers in a keratoconic population.
详细描述
Scleral contact lenses are rigid gas permeable lenses designed to rest on the sclera while vaulting over the cornea with a fluid reservoir. The use of scleral contact lenses has become the current standard of practice as a nonsurgical management of corneal ectasia and ocular surface diseases. Cases have been recently presented of scleral lens wearers exhibiting adverse corneal findings and conjunctival injection from lens wear. These findings are likely associated with the mechanical and hypoxic effects due to poor fitting characteristics at the limbal area. Tear film analysis detecting changes in the levels of proteinases and cytokines have helped researchers gain a better understanding of the pathophysiology of complications in soft contact lenses wearers, dry eye, and keratoconus. Ultimately, this study will provide insights in relating scleral lens fitting characteristics and corneal and limbal physiological responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Had been diagnosed with keratoconus in at least one eye.
- •Is at least 18 years of age and has full legal capacity to volunteer.
- •Has read and understood the information consent letter.
- •Is willing and able to follow instructions and maintain the appointment schedule.
排除标准
- •Is using any topical medications that will affect ocular health.
- •Has any ocular pathology or severe insufficiency of lacrimal secretion (severe dry eyes) that would affect the wearing of contact lenses.
- •Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- •Has any clinically significant lid or conjunctival abnormalities and active neovascularization.
- •Is aphakic.
- •Has undergone any corneal surgery.
- •Is participating in any other type of eye related clinical or research study.
- •Has any known allergies or sensitivity to the diagnostic pharmaceuticals or products, such as fluorescein, used in this study.
研究组 & 干预措施
ZenLens with Low limbal clearance
Scleral contact lens designed to provide approximately 25 microns of limbal clearance.
干预措施: ZenLens (Device)
ZenLens with High limbal clearance
Scleral contact lens designed to provide approximately 80 microns of limbal clearance.
干预措施: ZenLens (Device)
结局指标
主要结局
Tear Protein
时间窗: 2 weeks of lens wear with daily schedule of 6-8 hours.
To measure the level proteases and cytokines in each of the samples using Meso Scale Discovery system (MSD-ECL).
次要结局
- Comfort(2 weeks of lens wear with daily schedule of 6-8 hours.)
- Corneal thickness(2 weeks of lens wear with daily schedule of 6-8 hours.)
- Bulbar and limbal hyperemia(2 weeks of lens wear with daily schedule of 6-8 hours.)
研究者
Luigina Sorbara
Associate Professor
University of Waterloo