Myopia Progression and the Effect of 7-Methylxanthine
This trial is active, not recruiting.
|Sponsor||Trier Research Laboratories|
|Collaborator||Generalkonsul Einar Høyvalds Fond|
|Start date||October 2003|
|End date||March 2006|
|Trial size||90 participants|
|Trial identifier||NCT00263471, 2612-2320|
7-methylxanthine has been shown to increase the concentration and thickness of collagen fibrils in rabbit sclera. Deficient collagen in the sclera may be the cause of progression of childhood myopia. The study hypothesis is that treatment with 7-methylxanthine will stabilize the sclera and prevent further progression of myopia.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Male or female participants from 8 years up to 13 years old.
Inclusion Criteria: Children in the age 8-13 years with myopia and an axial growth rate of 0.15 mm or more per year. - Exclusion Criteria: Severe general ailment (for example diabetes, epilepsy, psychiatric disease) Eye diseases (for example cataract, keratoconus, chronic iritis, glaucoma) -
|Official title||Phase 2 Study of the Effect of 7-Methylxanthine on the Progression of Childhood Myopia|
|Description||Participants are given tablets of 7-methylxanthine 400 mg per day or placebo tablets for 12 months. Axial length, cycloplegic refraction and corneal curvature is measured, as well as weight, height, blood pressure and heart rate. The participants are interviewed about possible CNS, gastrointestinal, or cardiopulmonal side effects.|
Call for more information