Conformity of Conjunctival Hyperemia Assessment in Soft Contact Lens Wearers Using Image J Analysis and Efron Degree System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Efron degree system for hyperemia degree
研究概览
简要总结
Soft Contact Lens (SCL) use all over the world is still increasing. Ocular surface inflammatory reaction is the most common risk of using SCL. Currently, the standard used to assess this complication is the Efron Degree System (EDS), but it has high variability due its subjectivity. ImageJ gives more objective result with conjunctival vasodilation and vascular density assessment, so that complication management can be given earlier.
Purpose: Evaluate the suitability of SDE with ImageJ analysis in assessing conjunctival hyperemia in SCL use within 2 weeks.
详细描述
This is a paired prospective analytic study. Subjects with myopia who have not used SCL routinely before were instructed to use SCL for 14 days. Conjunctival inflammation were assessed with slit lamp examination before, at day 7, and day 14 of using SCL. Slit lamp pictures were analysed with EDS and ImageJ to be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Conjunctival inflammation degree evaluation was done with taking picture of conjunctiva using slit lamp by lead researcher. Picture was taken on day 0 (before using SCL), day 7, and day 14 of wearing SCL. Pictures then were analyzed with Efron Degree System (EDS) by 2 evaluators (both were ophthalmologist consultants) and with ImageJ application by lead researcher. ImageJ analysis was done to decide conjunctival vascular diameter and density. EDS evaluator did not know the results of the assessment with ImageJ and vice versa.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subject with mild to moderate myopia (-0.50 to -6.00 D)
- •age between 18-45 years old
- •subject who refuse refractive correction with glasses or surgery
- •patient with astigmatism refractive error no more than -1 Diopter
排除标准
- •subject with previous intraocular surgery
- •subject who is wearing SCL continuously
- •subject with history of dry eyes, uveitis, glaucoma, or corneal and conjunctival disorders
- •subject with history of allergic reaction to contact lens material or lens wetting solution used in this study
- •subject with ongoing eye drop treatment
- •female subject with ongoing pregnancy or on breastfeeding
- •subject with too improper lens fitting
- •subject who work around exposure of chemical substance, smoke, hazardous gas, or fire sparks
结局指标
主要结局
Efron degree system for hyperemia degree
时间窗: on day 0 (before using SCL), day 7, and day 14
Hyperemia grade based on Efron degree system, identified by percentage of hyperemia on the bulbar dan limbal conjunctiva * Normal * Trace * Mild * Moderate * Severe
Image J analysis of hyperemia degree
时间窗: on day 0 (before using SCL), day 7, and day 14
Vascular density (%area) and Vascular diameter (μm )
次要结局
未报告次要终点
研究者
dr. Tri Rahayu, SpM(K), FIACLE
MD
Indonesia University