Daily Low-level Red Light and 0.01% Low-dose Atropine for... | NCT06727019

Studies
Daily Low-level Red Light and 0.01% Low-dose Atropine for Myopia Prevention

NCT06727019

Sponsor

Beijing Tongren Hospital

Status

Completed

Last Update Posted

Dec 10, 2024Actual

Enrollment

138Actual

Phase

Not Applicable

Conditions

Myopia

Interventions

low-level red-light
Atropine (0.01%)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 10, 2023Actual

Primary Completion Date

Sep 15, 2023Actual

Completion Date

Sep 15, 2023Actual

First Submitted Date

Dec 3, 2024

First Submission Date that Met QC Criteria

Dec 5, 2024

First Posted Date

Dec 10, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2024

Last Update Posted Date

Dec 10, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

138Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
red-light	Experimental	In the low-level red-light (LLRL) group, the children used LLRL irradiation twice a day for 3-minute sessions, ensuring a gap of over 4 h between each use	Device: low-level red-light
atropine	Experimental	participants in the atropine group used 0.01% low-dose atropine eye drops once each night	Drug: Atropine (0.01%)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
low-level red-light	Device	650-nm low-level red-light	red-light
Atropine (0.01%)

Measure	Description	Time Frame
Incidence of myopia	12-month incidence of myopia	12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Aged at least 7 years old. 2. The spherical equivalent error (SER) after pupil dilation was between -0.5 D and +0.75D.

3. Had a record of cycloplegia SER at least 6 months before this study, and SER changed -0.5D compared with the last measurement or had a family history of high myopia.

4. Corneal astigmatism ≤ 1.25D. 5. Interocular refraction discrepancy ≤ 1.5D. 6. No allergy history of cycloplegia drugs. 7. Willingness to participate in the study and signed informed consent.

Exclusion Criteria:

- 1. Intraocular pressure was below 10 mm Hg or higher than 22 mm Hg. 2. Presence of amblyopia, or ocular pathological conditions such as retinal, lens, or corneal disorders.

3. Children currently using other myopia interventions other than LDA or LLRL. 4. Children with systemic and immune disorders, such as albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, and diabetes 5. Individuals with conditions like Tourette's syndrome or epilepsy.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Liya Qiao, PhD	Beijing Tongren Hospital	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participant data would be avialable on reasonable request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

ID	Term
D001286	Atropine Derivatives
D014326	Tropanes
D053961	Azabicyclo Compounds
D001372	Aza Compounds