NCT06738095

Brief Summary

100 eyes of ultra-high myopia were treated with daily low-level red-light. The age of children ranged from 3 to 16.3 years. The follow-up duration was one year. The objective was to explore the effect of daily low-level red-light on ultra-high myopia treatment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2022

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
Last Updated

December 17, 2024

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

December 13, 2024

Last Update Submit

December 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in axial length

    One year changes in axial length

    one year

Study Arms (1)

red-light

EXPERIMENTAL

Children with ultra-high myopia were treated with daily low-level red-light, which was used twice a day, with four hours interval. Three minutes for each session of treatment

Device: daily low-level red-light

Interventions

Daily low-level red-light is a kind of myopia intervention. Red-light typically using 650-nm wave of length. The treatment duration last 3 minutes each time, every day children were anticipated to use two times, at home.

red-light

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • A. The age is over 3 years old and under 18 years old. B. The spherical equivalent error is ≤ -6 D diopter . D. be able to cooperate to complete various eye examinations. E. be able to attend follow-up according to the specified time. F the guardian can accompany the use of the instrument.

You may not qualify if:

  • A. Complications associated with high myopia (such as choroidal neovascularization, macular split or hole, Rhegmatogenous retinal detachment); B other macular diseases (central serous retinopathy) or other eye diseases (e.g.Glaucoma, cataract, uveitis); C complicated with photosensitivity, psoriasis, albinism, hyperactivity disorder, nephrotic syndrome and systemic erythema Immune system diseases such as lupus; D. other systemic diseases or pregnancy; E. other similar instruments have been used for treatment in the past six months.
  • F. can't cooperate to complete various eye examinations. G. The guardian cannot accompany the use of this instrument.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital

Beijing, China, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 13, 2024

First Posted

December 17, 2024

Study Start

January 18, 2022

Primary Completion

August 23, 2022

Study Completion

August 23, 2022

Last Updated

December 17, 2024

Record last verified: 2022-01

Locations