Myopia Control Combined PBM With Myopic Defocus Lens in Children
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PBM therapy + SVS Low lever red light therapy with single vision spectacles |
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
Other Names:
Device: Single vision spectacles
Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction)
Other Names:
|
| Experimental: Peripheral defocus spectacles a spectacles with special design with peripheral myopic defocus to control myopia progression |
Device: Peripheral defocus spectacles
plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina
Other Names:
|
| Experimental: PBM +Peripheral defocus spectacles Low lever red light therapy with a spectacles with special design with peripheral myopic defocus to control myopia progression |
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
Other Names:
Device: Peripheral defocus spectacles
plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina
Other Names:
|
| Placebo Comparator: Control single vision spectacles only as the control |
Device: Single vision spectacles
Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
Secondary Outcome Measures
- 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
- 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
Other Outcome Measures
- Adverse Event [6 month]
Any adverse event reported by subjects or doctors related or un-related to the product during the whole study period
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | the first people's hospital of Xuzhou | Xuzhou | Jiangsu | China | 210000 |
Sponsors and Collaborators
- Beijing Airdoc Technology Co., Ltd.
- The First People's Hospital of Xuzhou
Investigators
- Study Director: Yan Wang, BA, The First People's Hospital of Xuzhou
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Xuzhou First People's Hospital