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Intravitreal and Intracameral DEX in NPDR

Effect of Intravitreal and Intracameral Injection of Dexamethasone Sodium Phosphate on Mild to Moderate NPDR During Cataract Phacoemulsification

Status
Enrolling by invitation
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06951087
Enrollment
80
Registered
2025-04-30
Start date
2022-01-31
Completion date
2025-06-01
Last updated
2025-04-30

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

Conditions

Non-Proliferative Diabetic Retinopathy

Keywords

non-proliferative diabetic retinopathy, cataract phacoemulsification, cystoid macular edema

Brief summary

To investigate the effects of intravitreal and intracameral injection of dexamethasone during cataract phacoemulsification in patients with mild to moderate non-proliferative diabetic retinopathy

Detailed description

The study aims to analyze the impact of intravitreal and intracameral DEX in diabetic patients with NPDR who are undergoing phacoemulsification surgery. Specifically, the investigators will investigate its effects on postoperative macular central thickness, the development of DME, and the progression of DR.

Interventions

DRUGDexamethasone sodium phosphate

In patients with stable DR and no significant macular edema, intravitreal anti-VEGF injections after phacoemulsification surgery can prevent the worsening of postoperative macular edema and potentially improve final visual outcomes while maintaining safety. Laser coagulation and intravitreal anti-VEGF injections are currently considered the standard treatments for PDR. However, the cost of anti-VEGF drugs often prevents many patients from receiving regular and timely injections. Intravitreal corticosteroids may be used as an alternative to anti-VEGF agents.

Sponsors

Affiliated Hospital of Nantong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

type 2 diabetic cataracts patients who were diagnosed with mild to moderate NPDR

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
measure the central point thickness (CPT) and central foveal thickness (CFT)From enrollment to the end of treatment at 3 monthsoptical coherence tomography (OCT) was used to perform the retinal examination, macular cube scans (512 × 128) and measure the central point thickness (CPT) and central foveal thickness (CFT). The CPT measurement focused on a central circle with a diameter of 1mm, and the CFT was calculated as the average of three consecutive measurements

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026