Repeated Low-Level Red-Light Therapy for Shortening Axial Length

Eye Diseases Clinical Trial

Official title:

Repeated Low-Level Red-Light Therapy for Shortening Axial Length in Chinese High Myopia Children and Teenagers: a Prospective Single-Arm Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05550740
• Other study ID #: HMRL-SEPTC-2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 22, 2022
• Est. completion date: December 22, 2023

Study information

• Verified date: September 2022
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: Xiangui He
• Phone: 021-62717733
• Email: hxgcrco[@]shsyf.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 22, 2023
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eye Diseases
• High Myopia
• Myopia
• Refractive Errors

Intervention

Device:
• RLRL
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.

Locations

Country	Name	City	State
China	Shanghai Eye Disease Prevention and Treatment Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of axial length shortening >0.05 mm	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. The IOL Master is used to measure axial length (mm).	12 months
Secondary	Incidence rates of axial length shortening >0.10 mm and >0.20 mm	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. The IOL Master is used to measure axial length (mm).	12 months
Secondary	Magnitude of axial length shortening among shortened eyes	Magnitude of axial length shortening is characterized as the magnitude of axial length reduction among axial shortened eyes. The IOL Master is used to measure axial length (mm).	12 months
Secondary	Changes in choroidal structural and perfusion parameters	Changes in choroidal structural and perfusion parameters are characterized as the difference between each follow-up visit and corresponding baseline values. Swept-source optical coherence tomography and optical coherence tomography angiography are used to measure choroidal structural and perfusion parameters.	1, 3, 6 and 12 months
Secondary	Changes in retinal structures	Swept-source optical coherence tomography is used to measure retinal structures.	1, 3, 6 and 12 months
Secondary	Changes in axial length and other biometric parameters	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
Secondary	Change of cycloplegic spherical equivalent refraction (Diopter)	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
Secondary	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
Secondary	Change in best corrected visual acuity	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
Secondary	Incidence of self-reported adverse events	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	1, 3, 6 and 12 months