Effect of Defocus in Soft Contact Lenses on Internal Retinal Vascularization
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Measurement of Retinal blood vessel density measured by Triton OCT-A
研究概览
简要总结
The purpose of this study is to gain a better understanding of the retinal vascular changes that occur in response to the optical effect of a myopic defocus daily disposable soft contact lens (MDSL) in a group of healthy young myopic adults (18-35 years; myopia -1.00D to -4.00D; all genders). It will also learn about the acceptance of this visual correction modality compared to regular contact lenses.
The main questions to be answered are:
- To evaluate changes in retinal blood flow by visualizing retinal vascular density in the superficial and deep plexus after one week of MDSL wear.
- To evaluate changes in choroidal thickness at the macular level after one week of MDSL wear.
- To evaluate the visual comfort provided by this MDSL design using a questionnaire.
Researchers will compare the MDSL to a daily disposable single vision soft lens (SVSL) used to correct myopia to determine if the addition of a defocus area makes a difference in the retinal response to the visual signal.
Participants will be required to
- Wear both MDSL and SVSL for one week each, in a random order.
- Read letters to measure visual acuity
- Have a deep scan of their retina with an optical coherence tomography (OCT) device
- Rate the comfort and vision provided by both devices using a questionnaire.
详细描述
Objective:
The aim of this study is to gain a better understanding of the retinal vascular changes that occur in response to the optical effect of a myopic defocus daily disposable contact lens used in another (ongoing) research project (NCT05191134).
The primary objective of the study is to evaluate changes in retinal blood flow by visualizing retinal vascular density in the superficial and deep plexus following one week's wear of a high peripheral add soft contact lens in a population of young myopic adults.
The second objective is to assess changes in choroidal thickness at the macular level after one week's wear of the high peripheral add soft contact lens.
A third objective is to evaluate, through questionnaire, the visual comfort provided by this lens design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
The lenses used in this study are daily disposable. This means that for each type of lens worn, participants will receive 7 lenses of each type. Lenses will be delivered one type at a time for the next week. The lenses will be packaged with a neutral label with a lot number. It is impossible for the participant to know which type this lot number corresponds to. Therefore, they do not know what type of lens they will receive.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •· Astigmatism ≤ 1.00 D
- •Myopia between -0.50 and -4.00D
- •Aged between 18 and 35
- •Binocular acuity of 6/6 or better
排除标准
- •· Recent intake (< 3 months) of medication affecting blood pressure (e.g. hypotensive, anovulant, CNS stimulant, etc.).
- •Corneal dystrophy or irregularity
- •Use of topical ocular medications
- •Smoking (tobacco or marijuana)
- •Have contraindications to wearing soft contact lenses
- •Being currently under myopia control treatment or had been under control in the last 3 months
- •Being pregnant or breast-feeding
- •History of refractive surgery
- •Addiction to drugs or alcohol
结局指标
主要结局
Measurement of Retinal blood vessel density measured by Triton OCT-A
时间窗: Measurement done at baseline and after 1 week of contact lens wear
The TRITON angiographic optical coherence tomograph will be used in this research project. OCT-A is a non-invasive angiography that enables changes in retinal vascularization to be observed. This is achieved by analyzing the movement of erythrocytes in blood vessels using a series of B-scans. Retinal vessel density will be measured at the macular area and at the optic nerve head. (2 scans)
次要结局
未报告次要终点