Myopia Eye Diseases Myopia
Conditions
Interventions
Current interventions as of 24/11/2022:
Assignments to treatment will be allocated with concealment according to an objective computer-generated randomisation software program.
Phase I
Children will
83 in the placebo group). Trial subjects will include male and female children aged between 6-16 years, with myopia of -1.0 D or worse (spherical equivalent) in each eye and an astigmatic refractive e
Sponsors
Technological University of Dublin
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in spherical equivalent refraction from baseline to 24 months, measured by cycloplegic autorefraction using the Grand Seiko WAM5500 open field autorefractor | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 09/04/2021: 1. Efficacy, assessed by: 1.1.Change in ocular axial length at 12, 24 and 36 months, measured using a Topcon ALADDIN optical biometer 1.2. Change in spherical equivalent refraction at 12 months and 36 months, assessed by cycloplegic auto-refraction using the Grand Seiko WAM 5500 open field autorefractor 1.3. Percentage of participants who progress 0.75D in 24 months, assessed by cycloplegic auto-refraction using the Grand Seiko WAM 5500 open field autorefractor 1.4. Difference in rate of change in spherical equivalent refraction from 24 to 36 months between tapered and sudden treatment cessation, assessed by cycloplegic auto-refraction using the Grand Seiko WAM 5500 open field autorefractor 1.4. Difference in rate of change in spherical equivalent refraction from 24 to 36 months between tapered and sudden treatment cessation, assessed by cycloplegic auto-refraction using the Grand Seiko WAM 5500 open field autorefractor 1.4. Difference in rate of change in spherical equivalent refraction from 24 to 36 months between tapered and sudden treatment cessation, assessed by cycloplegic auto-refraction using the Grand Seiko WAM 5500 open field autorefractor 1.5. Difference in rate of change in axial from 24 to 36 months between tapered and sudden treatment cessation, assessed by Aladdin optical biometry. 2. Mechanisms of action, assessed by: 2.1. Effects on off-axis refraction at 24 months. Off-axis refraction at 30° nasally and temporally will be measured using the open field Shin Nippon autorefractor 2.2. Effects on ocular growth at 24 months, assessed using: 2.2.1. The following, measured using the Topcon ALADDIN optical biometer: 2.2.1.1. Ocular biometry 2.2.1.2. Corneal curvature 2.2.1.3. Anterior chamber depth 2.2.2. The following, measured using the Heidelberg Spectralis (a non-invasive Optical Coherence Tomographer): 2.2.2.1. Appearance of retinal vascular morphology 2.2.2.2. Retinal nerve fibre layer 2.2.2.3. Cho | — |
Countries
Ireland
Outcome results
None listed