Longitudinal Changes in Eye Shape in Young Adults Treated With Low-Dose Atropine and Soft Multifocal Contact Lenses
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in ocular shape
研究概览
简要总结
The goal of this clinical trial is to study changes in eye shape of nearsighted young adults using low-dose atropine eye drops or soft multifocal contact lenses. The main questions it aims to answer are:
- do low-dose atropine and soft multifocal contact lenses affect the shape of the peripheral eye?
- are changes in peripheral eye shape from these interventions influenced by changes in the focusing system of the eye?
Participants will:
- have multiple different types of photos taken
- have their prescription for glasses/contacts checked
- have their eye health checked, including the use of dilating eye drops
- be randomly assigned to use eye drops every night or wear special contact lenses daily instead of their typical contacts
- will complete five study visits over the course of 12 months
Researchers will compare young adults using low-dose atropine to those wearing soft multifocal contact lenses and to those using no intervention to see if using these interventions affects retinal shape.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
The participants and the examining investigator will not be masked to intervention. All measurements are objective in nature and not subject to examiner bias. All data images acquired will be coded to obscure participant ID by a study team member masked to intervention. This coding will allow for the examining investigator to complete image processing while masked to randomization assignment, thereby minimizing the chance of bias.
入排标准
- 年龄范围
- 21 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •best corrected visual acuity of 20/25 or better in each eye
- •nearsighted
- •current contact lens wearer
- •normal binocular vision (to be determined by an examiner at the first study visit)
排除标准
- •eye diseases (including lazy eye or eye turn)
- •pregnant, nursing, or planning a pregnancy in the next 12 months
- •history of refractive surgery (e.g., LASIK)
- •history of myopia control treatment
- •sensitivity to anesthetics or preservative in eye drops
- •difficulty with pupillary dilation
研究组 & 干预措施
Low-dose atropine
Participants randomized to low-dose atropine will instill one drop of 0.05% atropine in each eye at bedtime for 12 months.
干预措施: Atropine Ophthalmic (Drug)
Soft multifocal contact lenses
Participants randomized to soft multifocal contact lenses will wear MiSight 1-day disposable contact lenses for 5-7 days per week for 12 months.
干预措施: MiSight 1-day disposable contact lenses (Device)
Observation
Participants randomized to the observation arm will receive no intervention.
结局指标
主要结局
Change in ocular shape
时间窗: baseline to 12 months
ocular shape, as measured by the ellipsoid fit of the retina acquired by the photos taken with ocular ultrasound (ABSolu, Quantel Medical)
次要结局
- Axial elongation (or regression)(baseline to 12 months)
- Change in refractive error(baseline to 12 months)
- Change in accommodative response(baseline to 12 months)
研究者
Donald O Mutti, OD, PhD
EF Wildermuth Foundation Professor in Optometry
Ohio State University