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

Sponsor

Evidence Based Cataract Study Group (Other)

Overall Status

Recruiting

CT.gov ID

NCT05478356

Collaborator

(none)

100

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Drug: low-dose atropine eye drops Device: orthokeratology	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Progression of myopia [1 year]
The change of myopia (Ds)
Progression of axial length [1 year]
The change of axial length (mm)

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Visionly Eye Hospital	Beijing	Beijing	China	100038
2	Parkway Hospital	Shanghai	Shanghai	China	200001

Sponsors and Collaborators

Evidence Based Cataract Study Group

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peng ZHOU, Doctor, Evidence Based Cataract Study Group

ClinicalTrials.gov Identifier:

NCT05478356

Other Study ID Numbers:

EvidenceBCSG

First Posted:

Jul 28, 2022

Last Update Posted:

Jul 28, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myopia

Atropine

Ophthalmic Solutions

Study Results

No Results Posted as of Jul 28, 2022