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Recruiting NCT05756959

Myopia Control Combined PBM With Myopic Defocus Lens in Children

No phase Interventional Myopia, Progressive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PBM, Peripheral defocus spectacles, Single vision spectacles.
Who it may be relevant to
Registry conditions: Myopia, Progressive. Basic parameters: 6 years — 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • axial length (mm) [Time frame: 6 month]
  • SE (Diopter, D) [Time frame: 6 month]
Secondary outcome measures (4)
  • UCVA (logMar visual acuity record) [Time frame: 6 month]
  • BCVA (logMar visual acuity record) [Time frame: 6 month]
  • OCT [Time frame: 6-month]
  • SFCT （um) [Time frame: 6-month]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • the first people's hospital of Xuzhou — Xuzhou

Identifiers

NCT: NCT05756959 · Xuzhou First People's Hospital

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗