Repeatability of AO-SLO (Mona IIa) Technology and Cone Cell Density of Individuals Use Repeated Low-level Red-light Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RLRL(Model RS-200-2A, Eyerising; Suzhou Xuanjia Optoelectronic Technology Co., Ltd., Suzhou, China)).
- Who it may be relevant to
- Registry conditions: Myopia. Basic parameters: 6 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
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.
Interventions
- Device RLRL(Model RS-200-2A, Eyerising; Suzhou Xuanjia Optoelectronic Technology Co., Ltd., Suzhou, China))
use RLRL twice a day
Primary outcome measures
- The density of cone cells [Time frame: From enrollment to the end of treatment at 3 weeks]
Secondary outcome measures (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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tianjin Medical University Eye Hospital — Tianjin
Identifiers
NCT: NCT07160036 · 2025YK-52