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

NCT ID: NCT05478356

Last Updated: 2022-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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orthokeratology group

Group Type EXPERIMENTAL

orthokeratology

Intervention Type DEVICE

orthokeratology, ortho-K lenses

low-dose atropine group

Group Type ACTIVE_COMPARATOR

low-dose atropine eye drops

Intervention Type DRUG

low-dose atropine eye drops

Interventions

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low-dose atropine eye drops

low-dose atropine eye drops

Intervention Type DRUG

orthokeratology

orthokeratology, ortho-K lenses

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Evidence Based Cataract Study Group

OTHER

Sponsor Role lead

Responsible Party

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Peng ZHOU

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Visionly Eye Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Parkway Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Peng Zhou, M.D.

Role: CONTACT

17898805125

Facility Contacts

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Peng Zhou, M.D.

Role: primary

17898805125

Peng Zhou, M.D.

Role: primary

17898805125

Other Identifiers

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EvidenceBCSG

Identifier Type: -

Identifier Source: org_study_id

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