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

NCT07160036 | Recruiting

• 1 other identifier: 2025YK-52
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• The density of cone cells

  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

  From enrollment to the end of treatment at 3 weeks

Study Arms (2)

RLRL group

EXPERIMENTAL

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 RLRL Group

NO INTERVENTION

No use RLRL

Interventions

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

use RLRL twice a day

RLRL group

Eligibility Criteria

• Age: 6 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruihua Wei: lead
• Tianjin Medical University Eye Hospital: collaborator

Study Sites (1)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, 120120, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Ruihua Wei

  Tianjin Medical University Eye Hospital, Tianjin, Tianjin 120120 Recruiting

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guihua Liu

CONTACT

+8686428756; liuguihua1992@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: September 8, 2025
• Study Start: September 20, 2025
• Primary Completion: November 20, 2025
• Study Completion: December 20, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)