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RecruitingNCT07160036AO-SLOUpdated Sep 15, 2025

Repeatability of AO-SLO (Mona IIa) Technology and Cone Cell Density of Individuals Use Repeated Low-level Red-light Therapy

An interventional study of RLRL(Model RS-200-2A, Eyerising; Suzhou Xuanjia Optoelectronic Technology Co., Ltd., Suzhou, China)) in Myopia, sponsored by Ruihua Wei. Recruiting at 1 site in China. Open to participants aged 6 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Ruihua Wei · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Non-randomized
Ages
6 Years to 55 Years
Sex
All
01

Study summary

To explore the repeatability of AO-SLO (Mona IIa) technology and the difference of cone cell density between individuals who used or not used repeated low-intensity red light treatment

Read the detailed description

This study focuses on the population with long-term use of repetitive low-intensity myopia, exploring the safety of repetitive low-intensity red light over a long period of use, and providing data support and clinical guidance for the field of repetitive low-intensity red light. It investigates the repeatability of adaptive optics scanning laser ophthalmoscope technology and observes the safety of repetitive low-intensity red light treatment for children over a long period of use.

02

Conditions studied

  • Myopia

Browse trials for

03

Who can participate

Ages eligible
6 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 6 - 55 years old, gender not limited; Obtained informed consent.

Exclusion criteria

Exclusion Criteria:

  • Children with obvious strabismus and amblyopia
  • With congenital eye disease, such as congenital cataract, congenital retinal disease
  • Secondary myopia (such as premature retinopathy or other eye diseases in infants and children caused secondary myopia), or myopia combined with systemic syndrome (such as Marfan syndrome)
  • Had internal eye surgery (such as cataract extraction, intraocular lens implantation, anti-glaucoma surgery, etc.)
  • Refractive medium opacity (such as corneal disease, crystal opacity, etc.)
  • Bnormal intraocular pressure and clinical significance (IOP \<10 mmHg or IOP>21mmHg or binocular IOP difference ≥5mmHg)
  • Fundus chorioretinopathy (except for high myopia fundus degenerative changes) or other intraocular diseases
  • Optic nerve damage or congenital optic nerve dysfunction
  • Can not be regularly checked
  • The adjustment range is less than 8D or obvious near difficulties
  • Other reasons researchers think it is not suitable for inclusion in researchers
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    RLRL group

    Use RLRL (Model RS-200-2A, Eyerising; Suzhou Xuanjia Optoelectronic Technology Co., Ltd., Suzhou, China)

    Device: RLRL(Model RS-200-2A, Eyerising; Suzhou Xuanjia Optoelectronic Technology Co., Ltd., Suzhou, China))

  • No intervention
    No RLRL Group

    No use RLRL

Interventions

  • DeviceRLRL(Model RS-200-2A, Eyerising; Suzhou Xuanjia Optoelectronic Technology Co., Ltd., Suzhou, China))

    use RLRL twice a day

05

What researchers measure

Primary outcomes

  1. The density of cone cells

    Time frame: From enrollment to the end of treatment at 3 weeks

Secondary outcomes

  1. Repeatability of adaptive optics scanning laser ophthalmoscope technology of cone cell density

    Time frame: From enrollment to the end of treatment at 3 weeks

06

Study locations

1 of 1 sites recruiting
  • Tianjin Medical University Eye Hospital
    Tianjin, Tianjin Municipality 120120, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07160036
Lead sponsor
Ruihua Wei
Collaborators
Tianjin Medical University Eye Hospital
Responsible party
Ruihua Wei (Professor, Tianjin Medical University Eye Hospital) — Sponsor-investigator
First posted
Sep 8, 2025
Start date
Sep 20, 2025 (estimated)
Primary completion
Nov 20, 2025 (estimated)
Completion
Dec 20, 2025 (estimated)
Last update
Sep 15, 2025

Study contacts

Guihua Liu
Contact
liuguihua1992@163.com
+8686428756
Ruihua Wei
principal investigator · Tianjin Medical University Eye Hospital, Tianjin, Tianjin 120120 Recruiting

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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