Myopia Control Combined PBM With Myopic Defocus Lens in Children

Myopia, Progressive Clinical Trial

Official title:

Myopia Control Combined PBM With Myopic Defocus Lens in Children: Double-blind RCT for 6 Month

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05756959
• Other study ID #: Xuzhou First People's Hospital
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2023
• Source: Beijing Airdoc Technology Co., Ltd.
• Contact: Ying Li, MD, PHD
• Phone: +8615162130727
• Email: 834582241[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. completion date: December 31, 2027
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia
• Myopia, Degenerative
• Myopia, Progressive

Intervention

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

Locations

Country	Name	City	State
China	the first people's hospital of Xuzhou	Xuzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Airdoc Technology Co., Ltd.	The First People's Hospital of Xuzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Event	Any adverse event reported by subjects or doctors related or un-related to the product during the whole study period	6 month
Primary	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.	6 month
Primary	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.	6 month
Secondary	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	6 month
Secondary	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.	6 month
Secondary	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	6-month
Secondary	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	6-month