NCT06497699

A Real-world Study of DEXYCU in the Treatment of Inflammation After Cataract Surgery

A Real-world Study to Evaluate the Efficacy and Safety of 9% Dexamethasone Intraocular Injection for the Treatment of Inflammation Associated With Cataract Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: Ocumension Therapeutics (Shanghai) Co., Ltd · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, real-world study aimed to evaluate the efficacy and safety of Dexycu in treating postoperative inflammation of cataracts.

Detailed description

To evaluate the efficacy and safety of Dexycu in treating postoperative inflammation of cataracts in real-world clinical settings, medical history and follow-up data from 113 subjects of Dexycu group and 150 subjects of external control group will be prospectively collected in Hainan, China. Additionally, questionnaires will be collected from surgeons on 30 cases to evaluate the difficulty, duration and safety of the Dexycu injector.

Conditions

• Inflammation
• Cataract

Interventions

Type	Name	Description
DRUG	Dexycu	single injection,5ul solution,concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone

Timeline

• Start date: 2021-10-28
• Primary completion: 2023-07-08
• Completion: 2023-12-14
• First posted: 2024-07-12
• Last updated: 2025-09-03
• Results posted: 2025-09-03

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study