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

July 26, 2022 updated by: Peng ZHOU, Evidence Based Cataract Study Group
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100038
        • Recruiting
        • Visionly Eye Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200001
        • Recruiting
        • Parkway Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: orthokeratology group
Device: orthokeratology
orthokeratology, ortho-K lenses
Active Comparator: low-dose atropine group
Drug: low-dose atropine eye drops
low-dose atropine eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression of myopia
Time Frame: 1 year
The change of myopia (Ds)
1 year
Progression of axial length
Time Frame: 1 year
The change of axial length (mm)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evidence Based Cataract Study Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2022

Primary Completion (Anticipated)

August 31, 2023

Study Completion (Anticipated)

August 31, 2023

Study Registration Dates

First Submitted

July 26, 2022

First Submitted That Met QC Criteria

July 26, 2022

First Posted (Actual)

July 28, 2022

Study Record Updates

Last Update Posted (Actual)

July 28, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EvidenceBCSG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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