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NCT Number: NCT06497699

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

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

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hainan Traditional Chinese Medicine Hospital, Haikou, Hainan, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects must be able to understand and sign the informed consent form and be able to follow the study procedures.
  • Male or female subjects over 40 years of age who are scheduled to undergo cataract phacoemulsification surgery combined with intraocular lens implantation.

Exclusion criteria

  • Known hypersensitivity to dexamethasone or any component of the Dexycu.
  • History of intraocular inflammation of any cause in either eye, presence of corneal abnormalities or malnutrition.
  • Have high intraocular pressure, with an IOP(intraocular pressure) of > 21 mmHg in the test eye at screening, regardless of whether receiving anti-glaucoma monotherapy therapy.
  • Posterior capsule rupture or lens dislocation, anterior vitreal membrane rupture, vitreous prolapse and intraoperative floppy iris syndrome during cataract surgery.
  • Other conditions that the investigator considers inappropriate to participate the study.

Treatment and study plan

Dexycu

Drug

single injection,5ul solution,concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone

Primary outcomes

  1. Anterior Chamber Cell Clearing Rate

    Time frame: DAY 8

    The primary outcome is to compare the ratio of subjects with anterior chamber cell grade 0 at day 8 after cataract surgery of both Dexycu group and external control group.

    The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).

Sponsors and collaborators

Lead sponsor

Ocumension Therapeutics (Shanghai) Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2024
Registry last updated
Sep 3, 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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