The Effects of Low-dose Atropine and Orthokeratology in Pediatric Myopia Control

Myopia Clinical Trial

— AVO  

Official title:

The Effects of Low-dose Atropine and Orthokeratology in Pediatric Myopia Control

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05478356
• Other study ID #: EvidenceBCSG
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: July 2022
• Source: Evidence Based Cataract Study Group
• Contact: Peng Zhou, M.D.
• Phone: 17898805125
• Email: drzhoupeng[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Both orthokeratology and atropine eye drops are effective methods for myopia control, but few studies have compared them all together simultaneously. Therefore, the primary aim of the present study was to compare the effect of orthokeratology versus low-dose (0.01% and 0.02%) atropine on the control of myopia progression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

Best corrected visual acuity less then 0.00 log MAR (minimum angle of resolution) units Cycloplegic SER of - 1.0 D or less in both eyes. An inter-eye cycloplegic SER difference of 1.00 D or more.

Exclusion Criteria:

Children with cycloplegic cylinder refraction of more than + 1.00 D or less than - 1.00 D.

History of binocular vision problems, including strabismus. History of known ocular disorders, including media opacities, macular dysgenesis, optic nerve hypoplasia, perinatal brain injury, buphthalmos, and retinopathy of prematurity.

History of medication use that might have affected the refractive results. Systemic or developmental problems that might have hindered refractive development.

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• low-dose atropine eye drops
low-dose atropine eye drops

Device:
• orthokeratology
orthokeratology, ortho-K lenses

Locations

Country	Name	City	State
China	Visionly Eye Hospital	Beijing	Beijing
China	Parkway Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Evidence Based Cataract Study Group

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of myopia	The change of myopia (Ds)	1 year
Primary	Progression of axial length	The change of axial length (mm)	1 year