Repeated Low-Level Red-Light Therapy and Orthokeratology in Fast-progressing Myopia Control

Eye Diseases Clinical Trial

Official title:

The Multicenter Randomized Clinical Trial of Fast-progressing Myopia Control Using Repeated Low-Level Red-Light Therapy and Orthokeratology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04722874
• Other study ID #: 2020KYPJ156
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2021
• Est. completion date: June 2022

Study information

• Verified date: August 2021
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Xiao Yang, Professor
• Phone: +86-020-87330348
• Email: 1394392659[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this multicenter randomized clinical trial is to evaluate the adjunctive effect of repeated low-level red-light therapy (RLRL) and orthokeratology (ortho-k) on myopia control in ortho-k non-responders who have undergone ortho-k treatment but were still experiencing fast myopia progression.

Description:

Myopia constitutes a major threat to personal health globally for its increased prevalence. Moreover, its dose-related association with irreversible blindness complications such as myopic macular degeneration have been demonstrated. It is crucial to look for effective ways to control myopia in children to reduce risk of myopic pathologies in later life.

Orthokeratology (ortho-k) is the first-line optical method in myopia control, resulting in slowing axial elongation by 43-63%. However, results after ortho-k treatment vary among individuals. Methods with more accurate efficacy and wider application to slowing down myopia progression, especially for myopia with limited ortho-k response, are still urgently required.

Repeated low-level red-light (RLRL) therapy is an innovative and non-invasive therapeutic treatment for a variety of eye diseases. Our previous clinical study suggested RLRL could effectively retard myopia progression without clinically observable side effects.

The purpose of this study is to evaluate the adjunctive effect of RLRL and ortho-k on myopia control in ortho-k non-responders using a multicenter randomized controlled trial design. Ortho-k non-responders are defined as who have continuously undergone ortho-k treatment but were still experiencing fast myopia progression. The subjects will be randomly assigned to either experimental group (RLRL and ortho-k) or control group (ortho-k). Their axial length will be monitored over one year. Changes in axial length in the two groups will be compared.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

Inclusion Criteria:

1. Start to receive ortho-k treatment one year ago.

2. Age at enrolment: 8-13 years.

3. Ortho-k non-responders: those who have continuously undergone ortho-k treatment but were still experiencing fast myopia progression (annual axial elongation equal to or more than 0.5 mm) in the past one year in at least one eye.

4. Before wearing ortho-k lenses, spherical equivalent refractions (SERs) ranging from -1.00 to -5.00 Dioptres (D) and astigmatism less than -1.5 D in both eyes, anisometropia less than 1.5 D, and best corrected logMAR visual acuity (VA) equal to or better than 0 in both eyes.

5. Parents' understanding and acceptance of random allocation of grouping

Exclusion Criteria:

1. Strabismus and binocular vision abnormalities.

2. Ocular or systemic abnormalities.

3. Prior treatment of myopia control in the past three months, e.g. drugs, progressive addition lenses, bifocal lenses, etc.

4. Other contraindications.

Related Conditions & MeSH terms

• Eye Diseases
• Myopia
• Myopia, Degenerative
• Myopia, Progressive
• Refractive Errors

Intervention

Device:
• Ortho-k lenses
Ortho-k lenses will be administered nightly.
• RLRL
RLRL will be performed twice a day with an interval of at least 4 hours, each treatment last 3 minutes. Nightly treatment should be performed at least 30 minutes before ortho-k lens insertion.

Locations

Country	Name	City	State
China	The Second People's Hospital of Foshan	Foshan	Guangdong
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong
China	Tianjin Medical University Eye Center	Tianjin	Tianjin

Sponsors (3)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University	The Second People's Hospital of Foshan, Tianjin Medical University Eye Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial length change	Axial length change (mm) is characterized as the difference between 12-month follow-up visit and baseline values. The Lenstar is used to measure axial length (mm).	12 months
Secondary	Changes in other ocular parameters	The Lenstar is used to measure ocular parameters (e.g., cornea thickness, lens thickness). Change of each parameter is characterized as the difference between its 12-month follow-up visit and baseline values.	12 months
Secondary	Incidence of treatment-emergent adverse events	Incidence of treatment-emergent adverse events is the rate of treatment-emergent adverse events over the study period for subjects in both arms.	12 months