Myopia Control Combined PBM With Myopic Defocus Lens in Children

Not Applicable

Recruiting

• Conditions: Myopia, Progressive

• Registration Number: NCT05756959
• Lead Sponsor: Beijing Airdoc Technology Co., Ltd.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2022-12-12
• Status Verified: 2023-02
• Study First Submitted: 2023-02-05
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-03-07
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-09
• Primary Completion: 2027-08-01
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 304

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
SE (Diopter, D)	6 month	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.
axial length (mm)	6 month	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.

Secondary Outcome Measures

Name	Time	Method
SFCT （um)	6-month	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
UCVA (logMar visual acuity record)	6 month	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
BCVA (logMar visual acuity record)	6 month	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.
OCT	6-month	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

Trial Locations

Locations (1)

the first people's hospital of Xuzhou; 🇨🇳 Xuzhou, Jiangsu, China