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

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

Study Overview

• Status: Completed
• Conditions: Inflammation; Cataract
• Intervention / Treatment: Drug: Dexycu

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.

• Study Type: Interventional
• Enrollment (Actual): 263
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Bo'ao, China
    • Boao Super Hospital
  • Hainan
    • Haikou, Hainan, China
      • Hainan Traditional Chinese Medicine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; Single injection of DEXYCU in the treatment eye after cataract surgery.	Drug: Dexycu; single injection,5ul solution,concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone
No Intervention: Control Group; The clinical routine treatment after cataract surgery was adopted without intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anterior Chamber Cell Clearing Rate	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).	DAY 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anterior chamber cell clearing rates	Compare the percentage of subjects with anterior chamber clearing grade 0 at Day 1 and 30 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).	DAY 1 & 30
Anterior chamber flare clearing rates	Compare the percentage of subjects with anterior chamber flare grade 0 at Day 1 and 8 after cataract surgery of both Dexycu group and external control group. The slit lamp examination for anterior chamber flare (ACF) 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), grade 1 (trace), grade 2 (mild intensity), grade 3 (moderate intensity), or grade 4 (strong intensity). Anterior chamber flare clearing occurs when all the ACC are absent (grade 0).	DAY 1 & 8
Mean anterior chamber cell score	Compare the mean score of anterior chamber cell at Day 1 , 8 and 30 of the Dexycu group and external control group.	DAY 1 & 8 & 30
Mean anterior chamber flare score	Compare the mean score of anterior chamber flare at Day 1, 8 and 30 of the Dexycu group and external control group.	DAY 1 & 8 & 30
Change in central macular thickness	Compare the change in central macula thickness at Day 1 and 8 of the Dexycu group and external control group.	DAY 1 & 8
Change in vision	Use standard logarithmic visual acuity chart to measure and compare the change in vision of the Dexycu group and external control group, before and after cataract surgery.	DAY 1 & 8 & 30
Evaluate the ease of use of the Dexycu ejector	After the cataract surgery, surgeons are asked to fill in a questionaire designed to collect subjective assessment on the experience of using the drug ejector. 30 questionaires in total were collected.	DAY 0

Collaborators and Investigators

• Sponsor: Ocumension Therapeutics (Shanghai) Co., Ltd
• Investigators: Study Director: Zhixun Li, Ocumension Therapeutics (Shanghai) Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2021
• Primary Completion (Actual): July 8, 2023
• Study Completion (Actual): December 14, 2023

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Cataract Surgery; Postoperative Inflammation
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Lens Diseases; Pathological Conditions, Signs and Symptoms; Inflammation; Cataract; Sulfur Compounds; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Benzene Derivatives; Sulfonic Acids; Sulfur Acids; Benzenesulfonates; Arylsulfonates; Arylsulfonic Acids; Calcium Dobesilate
• Other Study ID Numbers: OT-502-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes