Myopia Progression and the Effect of 7-Methylxanthine

Phase 2

• Conditions: Myopia

• Registration Number: NCT00263471
• Lead Sponsor: Trier Research Laboratories

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2003-10
• Study Start: 2003-10
• Study First Submitted: 2005-12-06
• Study First Submitted QC: 2005-12-06
• Study First Posted: 2005-12-08
• Last Update Submitted: 2005-12-13
• Last Update Posted: 2005-12-14
• Study Completion: 2006-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Axial growth

Secondary Outcome Measures

Name	Time	Method
Myopia progression