Clinical trial NCT05768152: Repeated Low-Level Red-Light Therapy Shortens Axial Length
Official title: Repeated Low-level Red-light Therapy in High Myopia Children and Teenagers: a Prospective Single-arm Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High Myopia
Axial Length
Eye Diseases
Lead sponsor: The Second People's Hospital of Foshan
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to investigate the incidence and magnitude of axial length shortening after repeated low-level red-light therapy in high myopia children and teenagers.

Detailed description: High myopia has become a major public concern globally, which is characterized by excessive axial elongation of the eyeball. Axial elongation is accompanied by mechanical stretching and thinning of the choroid and sclera, causing vision-threatening complications. Repeated low-level red-light (RLRL) therapy is an emerging effective and safe therapy for myopia control. Previous clinical trials in China have observed clinically significant axial shortening after RLRL treatment.

The purpose of this study is to investigate and identify possible mechanism for axial length (AL) shortening after 12-month RLRL therapy in highly myopic children and teenagers aged 8-18 years. In addition to single vision spectacles, subjects will receive RLRL treatment at home under supervision of the parents/guardians according to a standard protocol. Axial length, visual acuity, cycloplegic spherical equivalent refraction, slit lamp, fundus camera and optical coherence tomography/angiography will be measured at 1-, 3-, 6- and 12-month follow-up visits.

Eligibility criteria: Inclusion Criteria:

1. Provision of consent.
2. Age: ≥ 8 and ≤ 18 years at enrolment.
3. High myopia: cycloplegic sphere of -6.00 diopters (D) or greater in both eyes.
4. Willing and able to participate in all required activities of the study.
5. The children currently on myopia control treatment can be recruited if myopia control treatments (including but not limited to atropine, orthokeratology, rigid gas-permeable lenses, defocus spectacles, etc.) are discontinued for at least 2 weeks.
6. Normal fundus, tessellated fundus or with peripapillary diffuse chorioretinal atrophy.

Exclusion Criteria:

1. Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome.
2. Pathologic myopia with signs of macula-involving diffuse chorioretinal atrophy, patchy chorioretinal atrophy, macular atrophy, lacquer cracks, myopic choroidal neovascularization or Fuchs' spots.
3. Strabismus and binocular vision abnormalities in either eye.
4. Previous any intraocular surgery affecting refractive status.
5. Other reasons, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.

Primary outcomes:
measure: Incidence rate of axial length shortening greater than 0.05 mm
timeFrame: 12 months
Secondary outcomes:
measure: Incidence rates of axial length reduction greater than 0.10 mm and 0.20 mm
timeFrame: 12 months
measure: Magnitude of axial length shortening among shortened eyes
timeFrame: 12 months
measure: Changes in choroidal thickness (μm)
timeFrame: 1, 3, 6 and 12 months
measure: Changes in axial length (mm)
timeFrame: 1, 3, 6 and 12 months
measure: Changes in corneal curvature (mm)
timeFrame: 1, 3, 6 and 12 months
measure: Changes in anterior chamber depth (mm)
timeFrame: 1, 3, 6 and 12 months
measure: Changes in white to white (mm)
timeFrame: 1, 3, 6 and 12 months
measure: Change of cycloplegic spherical equivalent refraction
timeFrame: 1, 3, 6 and 12 months
measure: Change of pathologic myopia fundus META-PM grading
timeFrame: 1, 3, 6 and 12 months
measure: Change in best corrected visual acuity
timeFrame: 1, 3, 6 and 12 months
measure: Incidence of self-reported adverse events
timeFrame: 1, 3, 6 and 12 months
Other outcomes:
Locations:
city: Foshan
country: China
facility: The Second People's Hospital of Foshan
state: Guangdong
Study officials:
References: