Safety and Efficacy Study of 0.5%, 0.1% & 0.01% Atropine Treatment to Both Eyes In Treatment of Myopia In Children

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find an optimal dose of atropine for preventing the rapid progression of myopia in children by comparing the efficacy, safety and functional impact of binocular treatment with 0.5%, 0.1% and 0.01% atropine and to develop a treatment regimen for the routine management of childhood myopia.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Singapore National Eye Centre
• Treatments: Atropine; Ophthalmic Solutions

Criteria

Inclusion Criteria:

1. Written Informed Consent from parent and assent from child has been obtained

2. Children aged 6 to 12 years

3. Refractive error of spherical equivalent -2.00 D or worse in each eye as measured by cycloplegic autorefraction

4. Active myopia progression of at least spherical equivalent -0.50 D over the last 12 months as determined or suggested by refractive records or change in lens power

5. Astigmatism of less than or equal to -1.50 D as measured by cycloplegic or non-cycloplegic autorefraction

6. Distance vision correctable to logMAR 0.2 or better in both eyes

7. A difference between non-cycloplegic subjective spherical refraction and cycloplegic subjective spherical refraction of not greater than -1.00 D

8. Normal intraocular pressure of not greater than 21 mmHg

9. Normal ocular health other than myopia

10. In good general health with no history of cardiac or significant respiratory diseases

11. No asthma-requiring medications in the past one year

12. No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride

13. Willing and able to comply with scheduled visits and other study procedures

Exclusion Criteria:

1. Ocular or systemic diseases which may affect vision or refractive error

2. Any ocular condition wherein topical atropine is contraindicated

3. Defective binocular function or stereopsis

4. Amblyopia or manifest strabismus including intermittent tropia

5. Previous or current use of atropine or pirenzepine

6. Any other conditions precluding adherence to the protocol including unwillingness to refrain from contact lens wear for the duration of the study