AO-SLO repeatability and cone cell density after repeated low-intensity red-light therapy
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
Run by Tianjin Medical University Eye Hospital · NCT07160036 · Data updated 2026-11-12
This test will see whether a high-resolution eye imaging device (AO-SLO) gives consistent cone cell density measurements and whether people with myopia aged 6–55 who used repeated low-intensity red-light therapy have different cone density.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 55 Years |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Tianjin Medical University Eye Hospital Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Status | Recruiting |
| Started | September 20, 2025 |
| Main results expected | November 20, 2025 |
| Study ends | December 20, 2025 |
| Registry record updated | September 15, 2025 |
| Trial ID | NCT07160036 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 6–55 with myopia who can attend regular visits and do not have congenital eye disease, prior intraocular surgery, significant strabismus/amblyopia, media opacity, optic nerve disease, or secondary myopia.
✕Probably not a fit
Patients with secondary myopia, congenital ocular disease, prior intraocular surgery, significant media opacity, abnormal intraocular pressure, optic nerve damage, or those unable to comply with regular visits are unlikely to benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study uses adaptive optics scanning laser ophthalmoscopy (AO-SLO, Mona IIa) to obtain high-resolution images of the cone photoreceptor mosaic and evaluates the repeatability of those measurements. It compares cone cell density between people with myopia who have used repeated low-intensity red-light therapy (RLRL, RS-200-2A) and those who have not, with imaging repeated over time. Participants aged 6–55 who meet ophthalmic inclusion criteria will undergo standardized imaging and clinical exams while investigators monitor ocular safety measures over long-term RLRL exposure. The trial excludes subjects with secondary or congenital eye disease, prior intraocular surgery, significant media opacity, optic nerve pathology, or those unable to attend regular follow-up.
Why it matters
Potential benefit: If successful, this work could validate a reliable imaging method and provide safety data to help clinicians decide whether repeated low-intensity red-light therapy is appropriate for managing myopia.
How similar studies have gone: Previous clinical work has shown repeated low-intensity red-light therapy can slow myopia progression in children, but using AO-SLO to measure cone density and long-term safety data remain relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China Recruiting
Study contacts
- Principal investigator: Ruihua Wei — Tianjin Medical University Eye Hospital, Tianjin, Tianjin 120120 Recruiting
- Study coordinator: Guihua Liu
- Email: liuguihua1992@163.com
- Phone: +8686428756
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.