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Myopia Progression and the Effect of 7-Methylxanthine

Phase 2 Study of the Effect of 7-Methylxanthine on the Progression of Childhood Myopia

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00263471
Enrollment
90
Registered
2005-12-08
Start date
2003-10-31
Completion date
2006-03-31
Last updated
2005-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

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.

Interventions

DRUG7-methylxanthine

Sponsors

Generalkonsul Einar Høyvalds Fond
CollaboratorUNKNOWN
Jørgen Bagenkop Nielsens Myopi-Fond
CollaboratorUNKNOWN
Chr. Andersen og hustru Ingeborg Andersen, f. Schmidts legat (fond) oprettet af deres datter, frk. Lilli Ellen Andersen.
CollaboratorUNKNOWN
Trier Research Laboratories
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
No

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) \-

Design outcomes

Primary

MeasureTime frame
Axial growth

Secondary

MeasureTime frame
Myopia progression

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026