Myopia:the Role of Cone Opsin Mutations & Glasses That Control Axial Elongation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Myopia progression measured by rate of axial elongation of the eye
研究概览
简要总结
- To determine the effect of spectacles with a red blocking filter on myopia progression in children.
- To determine the effect of spectacles with a holographic diffuser that spreads incident light rays over an angle of 0.5 degrees on myopia progression in children
- To determine the combined effects of spectacles with a red blocking filter and a diffuser that spreads incident light over an angle of 0.5 degrees on myopia progression in children.
详细描述
In this clinical trial we will determine whether commercially available lens tints that are normally used for cosmetic purposes or for blocking sunlight have a beneficial effect of slowing axial eye growth in children with myopia when used alone or in conjunction with a holographic diffuser that blurs the image slightly.
The following procedures will be performed on a total of 240 children from 8 to 13 years of age:
- Color vision tests (Richmond Hardy-Rand-Rittler pseudoisochromatic plate test and/or the Rayleigh match test and/or the Neitz Test of Color Vision), and machine-based vision tests using the Titmus tester (color vision, binocularity, acuity, and heterophoria tests);
- each subject will provide a blood sample or a buccal swab for genetic analysis of the long and middle wavelength cone photopigment genes in order to determine the relationship between the cone opsins and myopia;
- eye measurements including axial length and corneal curvature will be performed using the Zeiss Intraocular Lens Master;
- cycloplegic autorefraction will be doe at the beginning of the study before participants start wearing the study spectacles, after 18 months if wearing the study spectacles, and 6 months after participants stop wearing the study spectacles.
- subjects will be randomly assigned to one of four groups, consisting of 60 subjects each, each group will be assigned one of four study spectacles.
The study spectacles for all participants will have the optimal lens corrections for both eyes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •nearsighted having a refractive error of at least -0.5 diopters
- •myopia progression at least -.50 D per year in previous year
- •astigmatism and anisometropia not more than 1.5 D
- •distance monocular acuity 6/6 or better
- •near monocular acuity of 0.4 M or better
- •stereoacuity not more than 40 sec of arc at 40 cm
- •able to respond to subjective testing
- •no contact lens use during the study
- •able to comply with wearing the experimental lenses daily for 18 months
- •able to have axial length measurements accurately on the Zeiss Intraocular Lens Master
- •willing to donate a blood sample or a buccal swab for genetic analysis
- •can be refracted to 20/20 or 20/15
排除标准
- •glaucoma, amblyopia, strabismus
- •ocular disease
- •developmental delay
- •history of wearing bifocal lenses
- •any type of eye surgery
- •color vision deficiency
研究组 & 干预措施
color blocking tint
Spectacles with red-blocking tint subjects will wear glasses daily for 6 months and have
干预措施: Spectacles with red-blocking tint (Other)
holographic diffuser
Spectacles with color neutral tint subjects will wear glasses daily for 6 months and have
干预措施: Spectacles with holographic diffuser and color neutral tint (Other)
diffuser & color blocking tint
Spectacles with holographic diffuser and red-blocking tint subjects will wear glasses daily for 6 months and have
干预措施: Spectacles with holographic diffuser and red-blocking tint (Other)
holographic diffuser and neutral tint
Spectacles with holographic diffuser and color neutral tint subjects will wear glasses daily for 6 months and have
干预措施: Spectacles with color neutral tint (Other)
结局指标
主要结局
Myopia progression measured by rate of axial elongation of the eye
时间窗: every 3 months for 18 months
The axial length of both eyes will be measured before wearing the experimental eyeglasses, then once every three months thereafter for 18 months, and again 6 months after subjects stop wearing the study eye glasses. The rate of axial elongation will be calculated.
次要结局
- Myopia progression measured by cycloplegic autorefraction.(18 months)
研究者
Jay Neitz
Professor
University of Washington