Clinical trial NCT05550740: Repeated Low-Level Red-Light Therapy for Shortening Axial Length
Official title: Repeated Low-Level Red-Light Therapy for Shortening Axial Length in Chinese High Myopia Children and Teenagers: a Prospective Single-Arm Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: High Myopia
Refractive Errors
Eye Diseases
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to confirm the incidence and magnitude of axial length shortening after RLRL therapy in Chinese 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. 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 confirm and identify possible mechanism for axial length (AL) shortening after 12-month RLRL therapy in Chinese highly myopic children and teenagers aged 6-16 years. In addition to single vision spectacles, subjects will receive RLRL treatment at home under supervision of the parents according to a standard protocol. Axial length, visual acuity, cycloplegic spherical equivalent refraction, intraocular pressure, slit lamp, optical coherence tomography, optical coherence tomography angiography and ultrawide-field optical coherence tomography will be measured at 1-, 3-, 6- and 12-month follow-up visits. This trial will be extended to 3 years and follow-up visits are scheduled at 18-, 24-, 30- and 36-month.

Eligibility criteria: Inclusion Criteria:

1. Provision of consent.
2. Age: ≥ 6 and ≤ 16 years at enrolment.
3. High myopia: cycloplegic sphere ≤ -6.00 diopters (D) 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 >0.05 mm measured by the IOL Master
timeFrame: 12 months
Secondary outcomes:
measure: Incidence rates (%) of axial length shortening >0.10 mm and >0.20 mm measured by the IOL Master
timeFrame: 12 months
measure: Changes of axial length shortening (mm) among shortened eyes measured the IOL master
timeFrame: 12 months
measure: Changes in choroidal structural and perfusion parameters measured by the swept-source optical coherence tomography and optical coherence tomography angiography
timeFrame: 1, 3, 6 and 12 months
measure: Changes in retinal structures by the swept-source optical coherence tomography and optical coherence tomography angiography
timeFrame: 1, 3, 6 and 12 months
measure: Changes in axial length (mm) and other biometric parameters (mm, μm) by the IOL master
timeFrame: 1, 3, 6 and 12 months
measure: Change of cycloplegic spherical equivalent refraction (Diopter) by the autorefractor
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 (logMAR) by the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart
timeFrame: 1, 3, 6, and 12 months
measure: Incidence (%) of self-reported adverse events by the quesionnaire including but not limited to glare, flash blindness, and afterimages
timeFrame: 1, 3, 6 and 12 months
Other outcomes:
measure: Full myopia control rate (%) by the autorefractor
timeFrame: 36 months
measure: Morphological changes of the posterior ocular segment by the quantitative ultrawide-field optical coherence tomography
timeFrame: 36 months
measure: Changes in axial length (mm) and other biometric parameters (mm, μm) by the IOL master
timeFrame: 36 months
measure: Changes in choroidal structural and perfusion parameters measured by the swept-source optical coherence tomography and optical coherence tomography angiography
timeFrame: 36 months
measure: Change in visual acuity (logMAR) by the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart
timeFrame: 36 months
measure: Incidence (%) of self-reported adverse events by the quesionnaire including but not limited to glare, flash blindness, and afterimages
timeFrame: 36 months
Locations:
city: Shanghai
country: China
facility: Shanghai Eye Disease Prevention and Treatment Center
state: Shanghai
Study officials:
References: