Myopia Progression and the Effect of 7-Methylxanthine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2006-03-31

Brief Summary

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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

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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.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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7-methylxanthine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Children in the age 8-13 years with myopia and an axial growth rate of 0.15 mm or more per year.

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Exclusion Criteria

Severe general ailment (for example diabetes, epilepsy, psychiatric disease) Eye diseases (for example cataract, keratoconus, chronic iritis, glaucoma)

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Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Klaus Trier, MD

Role: STUDY_CHAIR

Trier Research Laboratories

References

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Trier K, Olsen EB, Kobayashi T, Ribel-Madsen SM. Biochemical and ultrastructural changes in rabbit sclera after treatment with 7-methylxanthine, theobromine, acetazolamide, or L-ornithine. Br J Ophthalmol. 1999 Dec;83(12):1370-5. doi: 10.1136/bjo.83.12.1370.

Reference Type BACKGROUND

PMID: 10574816 (View on PubMed)

Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.

Reference Type DERIVED

PMID: 36809645 (View on PubMed)

Cui D, Trier K, Munk Ribel-Madsen S. Effect of day length on eye growth, myopia progression, and change of corneal power in myopic children. Ophthalmology. 2013 May;120(5):1074-9. doi: 10.1016/j.ophtha.2012.10.022. Epub 2013 Feb 4.

Reference Type DERIVED

PMID: 23380471 (View on PubMed)

Other Identifiers

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2612-2320

Identifier Type: -

Identifier Source: org_study_id