Clinical trial NCT02544529: Echothiophate Iodide for the Prevention of Progression of Myopia
Official title: Echothiophate Iodide for the Prevention of Progression of Myopia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Myopia
Lead sponsor: Danbury Eye Physicians & Surgeons, PC
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 0
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cycloplegic Refraction
timeFrame: 12 weeks
Secondary outcomes:
measure: Axial Length
timeFrame: 12 weeks
measure: Choroidal Thickness
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Danbury
country: United States
facility: Danbury Eye Physicians & Surgeons, PC
state: Connecticut
Study officials:
affiliation: Danbury Eye Physicians & Surgeons, PC
name: Stephen A Mathias, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: