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Myopia Control Combined PBM With Myopic Defocus Lens in Children

Primary Purpose

Myopia, Progressive

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PBM
Peripheral defocus spectacles
Single vision spectacles
Sponsored by
Beijing Airdoc Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia, Progressive

Eligibility Criteria

6 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • the first people's hospital of XuzhouRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

PBM therapy + SVS

Peripheral defocus spectacles

PBM +Peripheral defocus spectacles

Control

Arm Description

Low lever red light therapy with single vision spectacles

a spectacles with special design with peripheral myopic defocus to control myopia progression

Low lever red light therapy with a spectacles with special design with peripheral myopic defocus to control myopia progression

single vision spectacles only as the control

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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.
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
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

Full Information

First Posted
February 5, 2023
Last Updated
March 7, 2023
Sponsor
Beijing Airdoc Technology Co., Ltd.
Collaborators
The First People's Hospital of Xuzhou
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1. Study Identification

Unique Protocol Identification Number
NCT05756959
Brief Title
Myopia Control Combined PBM With Myopic Defocus Lens in Children
Official Title
Myopia Control Combined PBM With Myopic Defocus Lens in Children: Double-blind RCT for 6 Month
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
August 1, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Airdoc Technology Co., Ltd.
Collaborators
The First People's Hospital of Xuzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Progressive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
304 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PBM therapy + SVS
Arm Type
Experimental
Arm Description
Low lever red light therapy with single vision spectacles
Arm Title
Peripheral defocus spectacles
Arm Type
Experimental
Arm Description
a spectacles with special design with peripheral myopic defocus to control myopia progression
Arm Title
PBM +Peripheral defocus spectacles
Arm Type
Experimental
Arm Description
Low lever red light therapy with a spectacles with special design with peripheral myopic defocus to control myopia progression
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
single vision spectacles only as the control
Intervention Type
Device
Intervention Name(s)
PBM
Other Intervention Name(s)
Low lever light therapy; low intensity red light therapy; low lever laser therapy; repeated red light therapy
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Peripheral defocus spectacles
Other Intervention Name(s)
Myopic defocus spectacles for myopia control
Intervention Description
plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina
Intervention Type
Device
Intervention Name(s)
Single vision spectacles
Other Intervention Name(s)
single vision glasseses for myopia correction lenses
Intervention Description
Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction)
Primary Outcome Measure Information:
Title
axial length (mm)
Description
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
Title
SE (Diopter, D)
Description
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 Outcome Measure Information:
Title
UCVA (logMar visual acuity record)
Description
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
Title
BCVA (logMar visual acuity record)
Description
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
Title
OCT
Description
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
Title
SFCT (um)
Description
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 Pre-specified Outcome Measures:
Title
Adverse Event
Description
Any adverse event reported by subjects or doctors related or un-related to the product during the whole study period
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Li, MD, PHD
Phone
+8615162130727
Email
834582241@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Qiao, PHD, MD
Phone
+15162127602
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Wang, BA
Organizational Affiliation
The First People's Hospital of Xuzhou
Official's Role
Study Director
Facility Information:
Facility Name
the first people's hospital of Xuzhou
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Li, MD.Ph.D.
Phone
+8615162130727
Email
834582241@qq.com
First Name & Middle Initial & Last Name & Degree
Weiming Yang, MD. PhD
First Name & Middle Initial & Last Name & Degree
Xiaoying Wang, MD. PhD.
First Name & Middle Initial & Last Name & Degree
Xingtao Zhou, MD. PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Myopia Control Combined PBM With Myopic Defocus Lens in Children

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