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Effect of Low-level Red-light on Ultra-high Myopia

NCT ID: NCT06738095

Last Updated: 2024-12-17

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

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-18

Study Completion Date

2022-08-23

Brief Summary

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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

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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red-light

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

Group Type EXPERIMENTAL

daily low-level red-light

Intervention Type DEVICE

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.

Interventions

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daily low-level red-light

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tongren Hospital

OTHER

Sponsor Role lead

Responsible Party

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cao kai

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Tongren Hospital

Beijing, China, China

Site Status

Countries

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China

Other Identifiers

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BeijingTH TRECKY239

Identifier Type: -

Identifier Source: org_study_id