Evaluation of Light Sensitivity and Visual Acuity Changes as Consequence of Rigid Gas Permeable (RGP) Scleral Contact Lenses With a Passive Artificial Iris
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Visual acuity assessment and comparison between Designs A, B and C by means of logMAR or equivalent value
研究概览
简要总结
Data from 15 healthy subjects will be recorded in two testing sessions spread on two days, using three lens designs (A, B and C). Before the measuring days, each subject will undergo an extra fitting session of a large-diameter scleral contact lens on the dominant eye, assessed by an experienced practitioner. The fitting data will be used to custom-make the three lens designs for each subject, thus ensuring their comfort and safety during the days of the experiments. During the experiment days baseline measurements will be obtained before and after pupil dilation and contact lens wear. During the first testing session data from the lens design A (reference lens without artificial iris) will be recorded. During the second testing session data from the lens designs B and C (lenses with artificial iris with different transmittances) will be recorded. In each testing session, contrast sensitivity and visual acuity will be evaluated and non-invasive imaging measurements will be undertaken (optical coherence tomography and slit lamp). A specific questionnaire will be given to the subject to assess comfort, light sensitivity, the horizontal visual angle and overall experience of the scleral lens and in combination with a pair of sunglasses category 3-4.
详细描述
First, the participant will be subjected to an RGP scleral contact lens fitting session, then during the second and third visits the participant will be subjected to several non-invasive procedures specific to the study in order to assess contrast sensitivity and visual acuity using the fitted and uniquely fabricated investigational medical devices. The tests will be performed after eye drops are supplied to dilate the pupil of the subjects (eye drops: tropicamide and phenylephrine). Besides the clinical experiments, the participant will be given a specific questionnaire in order to assess comfort, light sensitivity, horizontal visual angle and overall experience of the investigational medical device and in combination with a pair of sunglasses category 3-4. The investigators will document the occurrence of any adverse events and specific side effects during Day 2 and 3 (testing sessions with the investigational devices) in order to effectively assess their safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 45 years old
排除标准
- •Iris disorders (i.e. ocular albinism, coloboma, aniridia).
- •Known disease-related ocular surface problem (i.e. microbial keratitis).
- •Known ocular pathologies (except refractive disorders).
- •Coexistent ocular diseases impeding contact lens correction (i.e. glaucoma, previous ocular surgery).
- •Corneal scarring.
- •Low corneal endothelial cell count (< 1500 cells per mm2), with potential of corneal hypoxia-induced corneal edema induced by contact lens wear.
- •Wearing of contact lenses in the last 24 hours (prior to the interventions).
研究组 & 干预措施
Healthy volunteers
15 healthy volunteers for trials with passive artificial iris
干预措施: Scleral contact lens without a passive artificial iris (Device)
Healthy volunteers
15 healthy volunteers for trials with passive artificial iris
干预措施: Tropicamide and phenylephrine (Drug)
结局指标
主要结局
Visual acuity assessment and comparison between Designs A, B and C by means of logMAR or equivalent value
时间窗: 5 months from fitting session
Compare visual acuity values obtained with different designs
Contrast sensitivity assessment and comparison between Designs A, B and C by means of threshold percentage or equivalent value
时间窗: 5 months from fitting session
Compare contrast sensitivity values obtained with different designs
次要结局
- Device safety by comparing eventual adverse events with those found in scleral contact lenses(5 months from fitting session)
- Correct fitting(5 months from fitting session)
- Contact lens wear comfort, as assessed by subject data from questionnaires Rasch analyzed using a 4-Andrich ration scale model(5 months from fitting session)
- Visual acuity assessment and comparison between Designs B (low contrast) and C (high contrast) by means of logMAR or equivalent value(5 months from fitting session)
- Contrast sensitivity assessment and comparison between Designs B (low contrast) and C (high contrast) by means of threshold percentage or equivalent value(5 months from fitting session)
- Horizontal visual angle(5 months from fitting session)