NCT05478356

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

1.1 years

First QC Date

July 26, 2022

Last Update Submit

July 26, 2022

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

  • Progression of myopia

    The change of myopia (Ds)

    1 year

  • Progression of axial length

    The change of axial length (mm)

    1 year

Study Arms (2)

orthokeratology group

EXPERIMENTAL
Device: orthokeratology

low-dose atropine group

ACTIVE COMPARATOR
Drug: low-dose atropine eye drops

Interventions

low-dose atropine eye dropsDRUG

low-dose atropine eye drops

low-dose atropine group
orthokeratologyDEVICE

orthokeratology, ortho-K lenses

orthokeratology group

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Visionly Eye Hospital

Beijing, Beijing Municipality, 100038, China

RECRUITING

Parkway Hospital

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Peng Zhou, M.D.

CONTACT

17898805125drzhoupeng@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 26, 2022

First Posted

July 28, 2022

Study Start

August 1, 2022

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

July 28, 2022

Record last verified: 2022-07

Locations

CN(2)