Myopia
Conditions
Brief summary
The purpose of this study is to test the hypothesis that myopia progression can be slowed or prevented by low dose Echothiophate Iodide.
Detailed description
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.
Interventions
DRUGEchothiophate Iodide 0.03% Ophthalmic Solution
one drop to each eye three times per week for 18 weeks
DRUGCarboxymethylcellulose Sodium (0.5%)
one drop to each eye three times per week for 18 weeks
Sponsors
Danbury Eye Physicians & Surgeons, PC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
9 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cycloplegic Refraction | 12 weeks | Cycloplegic refraction change after 12 weeks of treatment with drug |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Axial Length | 12 weeks | Change in axial length after 12 weeks of treatment |
| Choroidal Thickness | 12 weeks | Change in choroidal thickness after 12 weeks of treatment |
Countries
United States
Outcome results
None listed