Clinical trial NCT05881655: Slow Myopia Progression With Different Irradiance Light
Official title: A Prospective Clinical Trial on Slow Myopia Progression With Two Different Irradiance Light at Baseline and Dynamic Changes at Follow-up
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia, Progressive
Lead sponsor: Beijing Airdoc Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Children's Medical Center
First posted: 2023-05-31
Enrollment: 75
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is a prospective clinical control study on red light control myopia with specail design spectacles for 75 children in 3 groups. Study Groups with two different powers of 0.6 mW and 1.2 mW at wavelength of 650nm. The control group is to wear the same brand and design spectalces as those two study groups. In addition, the progression of myopia is usually accompanied by the changes in a variety of ocular parameters, such as refractive error, reduced submacular choroidal thickness, and prolonged length of the ocular axis length.The goal is to test which power (1.2mW and 0.6mW) is better in myopic children for 3 month's follow-up and also to test how to get better result with the increaing or decreasing lighting power for the total 6 month follow-up results .

Detailed description: It is a prospective clinical control study on red light control myopia with specail design spectacles for 75 children in 3 groups. Each group has 25 myopic children. Study Groups with two different powers of 0.6 mW and 1.2 mW at wavelength of 650nm are randomized to be allocated into the 3 groups. The control group is to wear the same brand and design spectalces as those two study groups. In addition, the progression of myopia is usually accompanied by the changes in a variety of ocular parameters, such as refractive error, reduced submacular choroidal thickness, and prolonged length of the ocular axis length. All groups will be wearing a special lens named by Stellest with high aspherical lens design.

Eligibility criteria: Inclusion Criteria:

* 6\~12 years old
* Refractive Error of Myopia within -0.50 D\~-5.00 D, Anisometropia less or equal to 2.00D, The best corrected vision acuity is better or equal to 0.8 （decimal record).
* Written consent formed with supervisions and children with 6 month follow-up.

Exclusion Criteria:

* Photophobia or allergy to any cycloplegic eyedrops (such as tropcaine, cyclopentolate).
* Lesions in fundus or any part of eyeball with abnormal corrected vision such as keratoconus.
* Strabisumus with angles large or equal to 5 prism dioper.
* With other myopia control device such as atropine, Orthokeratology, Misight lens or other myopia control device.

Primary outcomes:
measure: Mean Change of Ocular Axial length elongation at follow-up from Baseline (mm)
timeFrame: 3-month
measure: Mean Change of Ocular Axial length elongation at follow-up from Baseline (mm)
timeFrame: 6-month
Secondary outcomes:
measure: Mean Change of Refractive Error at follow-up from Baseline (mm)
timeFrame: 3-month
measure: Mean Change of Refractive Error at follow-up from Baseline (mm)
timeFrame: 6-month
measure: Mean Change of Choroidal Thickness (um)
timeFrame: 3-month
measure: Mean Change of Choroidal Thickness (um)
timeFrame: 6-month
measure: Change of Fundus
timeFrame: 6-month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Children Medical Center
Study officials:
affiliation: Shanghai Children's Medical Center
name: Hong Liu, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: