Correlation Study of Corneal Nerve Changes and Dry Eye in Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- sub-basal corneal nerve density
研究概览
简要总结
This study aims to analyze the changes of corneal nerve morphology and function in contact lens-related dry eye(CLADE) patients and further discuss the role of corneal nerve in the genesis and development of CLADE.
详细描述
33 daily disposable soft contact lens wearers with dry eye disease(DED), 33 DED without contact lens wear and 33 normal control subjects will be involved in study. One experienced ophthalmologist will evaluate the DED symptoms and signs, which include ocular surface disease index(OSDI), tear film breakup time(TBUT), Schirmer Ⅰ test, corneal fluorescein staining, lissamine green staining and meibomian gland dropout rate. After evaluating, corneal sensitivity are measured using a Cochet-Bonnet aesthesiometer. Corneal nerve morphology will be assessed in the right eye using in vivo confocal microscopy(IVCM). Fifteen to twenty minutes after IVCM, 20μL of basal tears will be collected from the inferior meniscus of each participant to test tear neuropeptides. Then investigators analyse the correlation of corneal nerve changes and DED symptoms and signs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18years to 40 years；
- •Male or female DED patients based on Chinese Dry Eye Diagnosis Standard (2020) with or without contact lens wear；
- •Provision of written informed consent.
排除标准
- •Presence of any of the following conditions: active ocular infection, ocular inflammation, active ocular allergy, ocular surgical history, laser treatment in the last 3 months, Meibomian function (MGD) over grade 2 (the grade is according to the report of the International Workshop on MGD in 2011), severe blepharitis or obvious inflammation of the eyelid margin, which in the judgment of the investigator may interfere with the interpretation of the study results
- •Pregnant and lactating women, or those planning a pregnancy over the course of the study
- •Uncontrolled systemic disease
- •Suffer from diseases that may affect corneal nerves, such as keratoconus, trigeminal neuralgia, allergic conjunctivitis, etc.
结局指标
主要结局
sub-basal corneal nerve density
时间窗: baseline
Sub-basal corneal nerve plexus image will be acquired using a laser scanning confocal microscope. Sub-basal nerve fiber density will be calculated from a manual trace of the length of all nerve fibers in each 1 mm2 image.
sub-basal corneal nerve tortuosity
时间窗: baseline
Sub-basal corneal nerve plexus image will be acquired using a laser scanning confocal microscope. Sub-basal nerve tortuosity will be assessed using a grading scale separately by two experienced ophthamologist.
次要结局
- Tear break-up time (TBUT)(baseline)
- meibomian gland droupout rate(baseline)
- Corneal fluorescein staining(baseline)
- ocular surface disease index(OSDI)(baseline)
- Schirmer Ⅰ test (SⅠt)(baseline)
- corneal sensitivity(baseline)
- the concentration of CGRP(baseline)
- Lissamine green staning(baseline)
- the concentration of substance P(baseline)