跳至主要内容
临床试验/NCT02544529
NCT02544529撤回4 期

Echothiophate Iodide for the Prevention of Progression of Myopia

Danbury Eye Physicians & Surgeons, PC1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2016年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
发起方
入组人数
33
试验地点
1
主要终点
Cycloplegic Refraction

研究概览

简要总结

The purpose of this study is to test the hypothesis that myopia progression can be slowed or prevented by low dose Echothiophate Iodide.

详细描述

This pilot study is designed to establish proof of concept of a method to either slow or stop the progression of myopia in children between the ages of 8 and 15 years by using Echothiophate Iodide eye drops to alter the relationship between focusing (accommodation), eye alignment, and peripheral blurring. Echothiophate Iodide 0.03% eye drops have been used for years for the treatment of accommodative esotropia in children. A prospective double blind randomized study of 33 children with active development of myopia will be divided into a treatment group of 22 and a control group of 11. They will be treated for 18 weeks with four planned visits at 6 week intervals. The progression of myopia will be measured by a determination of the length of the eye (axial length measured by the IOL Master) and cycloplegic refractions. Influencing factors such as corneal changes, lens changes and macular choroidal thickness will be monitored for any significance. If successful, a larger and longer study to slow the rate of myopia with echothiophate iodide will be done in order to decrease the world's incidence of myopia currently at 25-33% in western countries and 85% in Asian countries. This would also reduce the financial burden of glasses and contact lenses as well as decrease the incidence of pathological eye disease due to high myopia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
9 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy children between 8-15 years of age
  • Documentation of progression of myopia within the 12 months prior to enrollment
  • Written informed consent/Assent for the study

排除标准

  • Any history of retinopathy of prematurity, glaucoma, cataracts, corneal disease, uveitis, manifest strabismus, nystagmus or ocular trauma
  • Any history of unstable asthma, diabetes, or juvenile idiopathic arthritis Asthma must be stable for three months prior to enrollment if utilizing oral or inhaled steroids
  • Systemic muscarinic agents, steroids, or anticholinesterase agents.
  • Benzalkonium chloride preservative allergy.
  • Astigmatism >0.75D
  • Anisometropia >1.50D
  • Pregnancy or a positive pregnancy test at the screening visit.

研究组 & 干预措施

Carboxymethylcellulose Sodium (0.5%)

Placebo Comparator

Carboxymethylcellulose Sodium (0.5%) one drop to each eye three times per week for 18 weeks

干预措施: Carboxymethylcellulose Sodium (0.5%) (Drug)

Echothiophate Iodide

Experimental

Echothiophate Iodide 0.03% one drop to each eye three times per week for 18 weeks

干预措施: Echothiophate Iodide 0.03% Ophthalmic Solution (Drug)

结局指标

主要结局

Cycloplegic Refraction

时间窗: 12 weeks

Cycloplegic refraction change after 12 weeks of treatment with drug

次要结局

  • Axial Length(12 weeks)
  • Choroidal Thickness(12 weeks)

研究者

发起方
Danbury Eye Physicians & Surgeons, PC
申办方类型
Other
责任方
Principal Investigator
主要研究者

Angela Smit

Director of Clinical Research Operations

Danbury Eye Physicians & Surgeons, PC

研究点 (1)

Loading locations...

相似试验