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NCT Number: NCT05756959

Myopia Control Combined PBM With Myopic Defocus Lens in Children

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.

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Key information

Conditions

Myopia, Progressive Eye Diseases Myopia Myopia, Degenerative Refractive Errors

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the first people's hospital of Xuzhou

Xuzhou, Jiangsu, 210000, China

Location status: Recruiting

Location contact

Weiming Yang, MD. PhD

SUB_INVESTIGATOR

Xiaoying Wang, MD. PhD.

PRINCIPAL_INVESTIGATOR

Xingtao Zhou, MD. PhD

PRINCIPAL_INVESTIGATOR

Ying Li, MD.Ph.D.

CONTACT

[email protected]

+8615162130727

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PBM

Device

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: Low lever light therapy; low intensity red light therapy; low lever laser therapy; repeated red light therapy

Peripheral defocus spectacles

Device

plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina

Other names: Myopic defocus spectacles for myopia control

Single vision spectacles

Device

Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction)

Other names: single vision glasseses for myopia correction lenses

Primary outcomes

  1. axial length (mm)

    Time frame: 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.

  2. SE (Diopter, D)

    Time frame: 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 outcomes

  1. UCVA (logMar visual acuity record)

    Time frame: 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

  2. BCVA (logMar visual acuity record)

    Time frame: 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.

  3. OCT

    Time frame: 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

  4. SFCT （um)

    Time frame: 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 outcomes

  1. Adverse Event

    Time frame: 6 month

    Any adverse event reported by subjects or doctors related or un-related to the product during the whole study period

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Qiao, PHD, MD

CONTACT

+15162127602

Ying Li, MD, PHD

CONTACT

[email protected]

+8615162130727

Sponsors and collaborators

Lead sponsor

Beijing Airdoc Technology Co., Ltd.

Industry

Collaborators

  • The First People's Hospital of Xuzhou

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 7, 2023
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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