Myopia Control Combined PBM With Myopic Defocus Lens in Children

ConditionMyopia, Progressive

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-13

SponsorBeijing Airdoc Technology Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

PBM
Device
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 spectacles
Device
plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina
Single vision spectacles
Device
Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction)

Treatment groups

304 Participants

are divided into 4 treatment groups

Group A: PBM therapy + SVSExperimental treatment 2 interventions

Group B: Peripheral defocus spectaclesExperimental treatment 1 intervention

Group C: PBM +Peripheral defocus spectaclesExperimental treatment 2 interventions

Group D: ControlPlacebo comparator 1 intervention

Trial 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

Time frame

6-month

Other outcomes

Adverse Event

Any adverse event reported by subjects or doctors related or un-related to the product during the whole study period

Time frame

6 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Airdoc Technology Co., Ltd.

Lead sponsor

The First People's Hospital of Xuzhou

Collaborator

Source ClinicalTrials.gov

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