Myopia Control Combined PBM With Myopic Defocus Lens in Children

Beijing Airdoc Technology Co., Ltd.304 enrolled

Overview

To study the efficacy of myopi control with two methods: low lever red light and peripheral defocus spectacles with four groups and design with prospective, double-blind, randimized, and with control for 6 month.

myopic children with age from 6 \~13 years old. And refraction from -0.50D\~-5.50D. The red light is low lever laser therapy at wavelength of 650nm.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

304

Conditions

Myopia, Progressive

Interventions

PBMDEVICE

PBM, is a low intensity red light at wavelength of 650nm; Peripheral defocus spectacels is a peripheral design glasseses for correct myopia and control myopia

Peripheral defocus spectaclesDEVICE

plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina

Single vision spectaclesDEVICE

Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction)

Eligibility

Sex: ALLMin age: 6 YearsMax age: 13 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Informed consent by the supervision of the children * 6\~13 years old (including both the 6 and 13) * SE range: -0.50\~-5.50D * Astigmatism \<=2.00D * BCVA \>=0.8 * Anisometropia \<=1.50D * Confirmed to no use of other myopia control intervention Exclusion Criteria: * Ocular lesions to effect vision or diseases (such as cataract, glaucoma, marcular pathology, cornea lesions, uveitis, retina detachment, congential opitc abnormal and etc.) * Halo, glare, toutic, ADHD, psoriasis * Systom disease: immune disease, central nerve system, Down syndrome, asthma, severe cardiopulmonary abnormal, severe liver and renal dysfunction. * Squint, ocular lesion or acute imflammation. * Other myopia control interventions within recent 3 month such as atropine, device, orthokeratology, multi-focus soft lens, multi-function spectacles.

Locations (1)

the first people's hospital of Xuzhou

Xuzhou, Jiangsu, China

RECRUITING

Outcomes

Primary Outcomes

axial length (mm)

Axial length changes at follow-up of 6 month from baseline will be measured by IOLmaster 500 at the same site by the same examiner with the mean values of 5 times measurements at either time. Changes in axial length (mm) without cycloplegia are to be measured by IOLmaster(Carl Zeiss). Five measurements will be taken and then averaged.

Time frame: 6 month

SE (Diopter, D)

changes of cycloplegic spherical equivalent from baseline will be measured under cycloplegic refraction by autorefractor. Five measured by the same autorefractor are to be obtained for each eye.

Time frame: 6 month

Secondary Outcomes

UCVA (logMar visual acuity record)

Uncorrected visual acuity will be measured under 5-meter distance logMar Visual acuity chart without any aid （including the spectacles or contact lens) at baseline and at follow-up

Time frame: 6 month

BCVA (logMar visual acuity record)

Best corrected visual acuity will be measured under the same 5-meter distance logMar Visual acuity as the UCVA both at baseline and at follow-up.

Time frame: 6 month

OCT

Opitcal coherence tomography(OCT) record The marcular sturcture and image scanned by the optical coherent topography will be measured by linear scan at the marcular by the same Optical coherence tomography with the same examiner and the same instrument both at baseline and at follow-up

Time frame: 6-month

SFCT （um)

Sub-forveal choroidal thickness will be measured with the same software in the same Optical coherence tomography (OCT) at the location from the foveal center manually

Central Contacts

Ying Li, MD, PHD

CONTACT

+8615162130727 834582241@qq.com

Lei Qiao, PHD, MD

CONTACT

+15162127602

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.