Myopia Control Combined PBM With Myopic Defocus Lens in Children

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

PBM

Peripheral defocus spectacles

Single vision spectacles

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

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

NCT ID

NCT05756959

First Posted

February 5, 2023

Last Updated

March 7, 2023

Sponsor

Beijing Airdoc Technology Co., Ltd.

Collaborators

The First People's Hospital of Xuzhou

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

Myopia, Progressive

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial