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Clinical study of wearable low-intensity pulsed ultrasound to improve retinal microcirculation and visual function of diabetic retinopathy

Clinical study of wearable low-intensity pulsed ultrasound to improve retinal microcirculation and visual function of diabetic retinopathy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070664
Enrollment
Unknown
Registered
2023-04-19
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Interventions

Treatment group(1.0W/cm2):low-intensity pulse ultrasound treatment (1.0W/cm2)
Treatment group (0.5W/cm2):low-intensity pulse ultrasound treatment (0.5W/cm2)
control:none

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed as non-proliferative diabetic retinopathy by fundus fluorescein angiography; (2) Patients diagnosed as proliferative diabetic retinopathy by fundus fluorescein angiography have no vitreous hemorrhage, proliferative membranes, or traction retinal detachment; (3) Patients aged 18-70 years old and volunteer to participate. Patient or patient's family agrees and signs an informed consent form; (4) Patients are able to cooperate with various studies in clinical trials.

Exclusion criteria

Exclusion criteria: (1) Patients with proliferative diabetic retinopathy who need vitrectomy according to clinical judgment; (2) Patients who were scheduled to undergo anti-VEGF therapy or retinal laser photocoagulation therapy at the time of enrollment; (3) Patients with diabetic macular edema; (4) Patients with refractive medium opacity; (5) Pre-exsiting ophthalmic diseases: glaucoma, other fundus diseases except diabetes retinopathy; (6) Previous intraocular surgery history; (7) Patients with poor compliance; (8) Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
retinal blood flow density;result of multifocal electroretinogram;

Secondary

MeasureTime frame
best corrected visual acuity;Number of retinal microangiomas;areas of retinal non-perfusion;areas of foveal avascular zone;Choroidal capillary blood flow density;

Countries

China

Contacts

Public ContactLu Xinmin

Shanghai Sixth People's Hospital

xinmin.lu@hotmail.com+86 13482307327

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026