AO-SLO repeatability and cone cell density after repeated low-intensity red-light therapy
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 6 Years to 55 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Eye Hospital Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT07160036 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Tianjin, Tianjin Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.