Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RLRL therapy | Experimental | In addition to SVS, participants will be treated with RLRL twice a school day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RLRL | Device | In addition to SVS with power for correcting distance refraction, RLRL will be performed twice per school day with an interval of at least 4 hours, each treatment last 3 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate (%) of axial length shortening >0.05 mm measured by the IOL Master | Incidence rate of axial length shortening > 0.05 mm is characterized as the ratio of number of participants with axial length shortening greater than 0.05 mm to the total number. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rates (%) of axial length shortening >0.10 mm and >0.20 mm measured by the IOL Master | Incidence rate of axial length shortening > 0.10 mm and 0.20 mm are characterized as the ratio of number of participants with axial length hortening greater than 0.10 mm and 0.20 mm to the total number. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Full myopia control rate (%) by the autorefractor | Cycloplegic spherical equivalent change (Diopter, D) is characterized as the difference between each follow-up visit and baseline values. Refraction with full cycloplegia is performed with an autorefractor. The data on spherical and cylindrical power and axis is automatically extracted from the autorefractor. The spherical equivalent power (D) is calculated as the spherical power (D) plus half of the cylindrical power (D). Full myopia control is defined as cycloplegic SER progression <0.25 D/year. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Eye Disease Prevention and Treatment Center | Shanghai | Shanghai Municipality | 20041 | China |
Data will be shared as open data after proper anonymization.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Changes of axial length shortening (mm) among shortened eyes measured the IOL master |
Changes of axial length shortening is characterized as the magnitude of axial length reduction among axial shortened eyes. |
| 12 months |
| Changes in choroidal structural and perfusion parameters measured by the swept-source optical coherence tomography and optical coherence tomography angiography | Changes in choroidal structural and perfusion parameters are characterized as the difference between each follow-up visit and corresponding baseline values. Indicators include choroidal vascular index, choroidal thickness and so on. | 1, 3, 6 and 12 months |
| Changes in retinal structures by the swept-source optical coherence tomography and optical coherence tomography angiography | Swept-source optical coherence tomography is used to measure retinal structures. The structures of nerve sensory layer, retinal pigment epithelium layer and choroid layer were observed by fundus images. | 1, 3, 6 and 12 months |
| Changes in axial length (mm) and other biometric parameters (mm, μm) by the IOL master | The IOL Master is used to measure axial length and other biometric parameters, including corneal curvature, anterior chamber depth and white to white, etc. Change of each parameter is characterized as the difference between each follow-up visit and baseline values | 1, 3, 6 and 12 months |
| Change of cycloplegic spherical equivalent refraction (Diopter) by the autorefractor | Cycloplegic spherical equivalent change (Diopter, D) is characterized as the difference between each follow-up visit and baseline values. Refraction with full cycloplegia is performed with an autorefractor. The data on spherical and cylindrical power and axis is automatically extracted from the autorefractor. The spherical equivalent power (D) is calculated as the spherical power (D) plus half of the cylindrical power (D) | 1, 3, 6 and 12 months |
| Change of pathologic myopia fundus META-PM grading | The swept-source optical coherence tomography is used to obtain fundus images. The fundus images are classified based on META-PM classification system | 1, 3, 6 and 12 months |
| Change in best corrected visual acuity (logMAR) by the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart | Best corrected visual acuity change is characterized as the difference between each follow-up visit and baseline values. An Early Treatment Diabetic Retinopathy Study chart with standard illumination at a distance of 4 meters is used to measure best corrected visual acuity | 1, 3, 6, and 12 months |
| Incidence (%) of self-reported adverse events by the quesionnaire including but not limited to glare, flash blindness, and afterimages | Incidence of self-reported adverse events is the rate of self-reported adverse events over a specified period for all the subjects. | 1, 3, 6 and 12 months |
| 36 months |
| Morphological changes of the posterior ocular segment by the quantitative ultrawide-field optical coherence tomography | Morphological changes of the posterior ocular segment is measured using the quantitative ultrawide-field optical coherence tomography between follow-up visit and baseline. | 36 months |
| Changes in axial length (mm) and other biometric parameters (mm, μm) by the IOL master | The IOL Master is used to measure axial length and other biometric parameters, including corneal curvature, anterior chamber depth and white to white. Change of each parameter is characterized as the difference between each follow-up visit and baseline values. | 36 months |
| Changes in choroidal structural and perfusion parameters measured by the swept-source optical coherence tomography and optical coherence tomography angiography | Changes in choroidal structural and perfusion parameters are characterized as the difference between each follow-up visit and corresponding baseline values. Indicators include choroidal vascular index, choroidal thickness and so on. | 36 months |
| Change in visual acuity (logMAR) by the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart | Visual acuity change is characterized as the difference between each follow-up visit and baseline values. An ETDRS chart with standard illumination at a distance of 4 meters is used to measure visual acuity. | 36 months |
| Incidence (%) of self-reported adverse events by the quesionnaire including but not limited to glare, flash blindness, and afterimages | Incidence of self-reported adverse events is the rate of self-reported adverse events over a specified period for all the subjects. Subjects are asked to report any treatment-emergent adverse events, including but not limited to glare, flash blindness, and afterimages. | 36 months |