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

September 8, 2025 updated by: Ruihua Wei

Exploring the Repeatability of Adaptive Optics Scanning Laser Ophthalmoscope Technology (AO-SLO Mona IIa) and the Differences in Cone Cell Density Between Individuals Who Undergone and Not Undergone Repeated Low-level Red-light

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 120120
        • Recruiting
        • Tianjin Medical University Eye Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No RLRL Group
No use RLRL
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))
use RLRL twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The density of cone cells
Time Frame: From enrollment to the end of treatment at 3 weeks
From enrollment to the end of treatment at 3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Repeatability of adaptive optics scanning laser ophthalmoscope technology of cone cell density
Time Frame: From enrollment to the end of treatment at 3 weeks
From enrollment to the end of treatment at 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruihua Wei

Collaborators

Tianjin Medical University Eye Hospital

Investigators

  • Principal Investigator: Ruihua Wei, Tianjin Medical University Eye Hospital, Tianjin, Tianjin 120120 Recruiting

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 20, 2025

Primary Completion (Estimated)

November 20, 2025

Study Completion (Estimated)

December 20, 2025

Study Registration Dates

First Submitted

August 30, 2025

First Submitted That Met QC Criteria

August 30, 2025

First Posted (Estimated)

September 8, 2025

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025YK-52

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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