Efficacy, safety and mechanisms of atropine eyedrops in slowing the progression of shortsightedness (myopia) in childre

Phase 2

• Conditions: Myopia; Eye Diseases

• Registration Number: ISRCTN36732601
• Lead Sponsor: Technological University of Dublin

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/32002514 protocol (added 03/02/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-04
• Last Update Posted: 9 January 2023
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Current participant inclusion criteria as of 16/07/2018:
1. Between 6-16 years old of either gender
2. A spherical equivalent refractive error of -1.0D or worse
3. Myopic progression of at least -0.50DS over the last year
4. Astigmatism less than or equal to -2.50D
5. An intraocular difference in spherical equivalent <= 1D
6. Corrected visual acuity better or equal to logMAR 0.2 ?in both eyes
7. A difference between non-cycloplegic and cycloplegic spherical refraction of less than 1.00 D
8. Normal IOP (<= 21mmHg)
9. Normal ocular health
10. Good general health with no history of cardiac/respiratory diseases
11. Be willing to commit to the 2 year clinical trial as well as randomisation to the placebo

Previous participant inclusion criteria:
1. Between 6-16 years old of either gender
2. A spherical equivalent refractive error of -1.0D or worse
3. Myopic progression of at least -0.50DS over the last year
4. Astigmatism less than or equal to -1.50D
5. An intraocular difference in spherical equivalent <= 1D
6. Corrected visual acuity better or equal to logMAR 0.2 ?in both eyes
7. A difference between non-cycloplegic and cycloplegic spherical refraction of less than 1.00 D
8. Normal IOP (<= 21mmHg)
9. Normal ocular health
10. Good general health with no history of cardiac/respiratory diseases
11. Be willing to commit to the 2 year clinical trial as well as randomisation to the placebo

Exclusion Criteria

1. Any ocular or systemic condition affecting vision or refractive error or where atropine is contraindicated
2. Any known allergy to atropine, cyclopentolate hydrochloride and/or proxymetacaine hydrochloride
3. Defective binocular vision, amblyopia or strabismus
4. Experienced previous pharmaceutical or optical myopia control interventions
5. If subjects (or parent/guardian) are unable to provide written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in spherical equivalent refraction from baseline to 24 months, measured by cycloplegic autorefraction using the Grand Seiko WAM5500 open field autorefractor