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

NCT ID: NCT07160036

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-20

Study Completion Date

2025-12-20

Brief Summary

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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

Detailed Description

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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.

Conditions

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Myopia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RLRL group

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

use RLRL twice a day

No RLRL Group

No use RLRL

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

use RLRL twice a day

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Eye Hospital

OTHER

Sponsor Role collaborator

Ruihua Wei

OTHER

Sponsor Role lead

Responsible Party

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Ruihua Wei

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ruihua Wei

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Eye Hospital, Tianjin, Tianjin 120120 Recruiting

Locations

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Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guihua Liu

Role: CONTACT

+8686428756

Facility Contacts

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Guihua Liu

Role: primary

8686428756

Other Identifiers

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2025YK-52

Identifier Type: -

Identifier Source: org_study_id

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