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OpenTrials
Enrolling by Invitation

NCT Number: NCT06951087

Intravitreal and Intracameral DEX in NPDR

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

Enrolling by Invitation

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Eye Institute, Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Dexamethasone sodium phosphate

Drug

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.

Primary outcomes

  1. measure the central point thickness (CPT) and central foveal thickness (CFT)

    Time frame: From enrollment to the end of treatment at 3 months

    optical 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

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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