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The Efficacy and Safety of Subretinal Balanced Salt Solution Injection in Diabetic Macular Edema with Hard Exudates

The Efficacy and Safety of Subretinal Balanced Salt Solution Injection in Diabetic Macular Edema with Hard Exudates

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102626
Enrollment
Unknown
Registered
2025-05-16
Start date
2020-04-15
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

Diabetic Macular Edema with Hard Exudates

Interventions

Injection group:Subretinal balanced salt solution injection with pars plana vitrectomy and internal limiting membrane peeling
Control group:Pars plana vitrectomy and internal limiting membrane peeling

Sponsors

The People’s Hospital of Dehong Prefecture
Lead Sponsor

Eligibility

Sex/Gender
All
Age
33 Years to 75 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria were as follows: patients with DME with vision impairment (Snellen visual acuity <20/60) and foveal hard exudates. The patient with DME underwent anti-VEGF therapy three times, and vision was not rescued. Optical coherence tomography (OCT) revealed a central macular thickness (CMT) exceeding 250 µm and hyperreflective material around the fovea.

Exclusion criteria

Exclusion criteria: The exclusion criteria were as follows: patients with other fundus disorders, such as retinal detachment or severe vitreous haemorrhage that prevented fundus examination; patients with a follow-up time of less than six months; and those who underwent retinal surgery before this study.

Design outcomes

Primary

MeasureTime frame
Best corrected visual acuity ;

Secondary

MeasureTime frame
Central macular thickness;Mean macular thickness;Foveal avascular zone;

Countries

China

Contacts

Public ContactBoai Li

The People’s Hospital of Dehong Prefecture

liboai93@163.com+86 692 210 4005

Outcome results

None listed

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