A Real-world Study to Evaluate the Efficacy and Safety of 9% Dexamethasone Intraocular Injection for the Treatment of Inflammation Associated With Cataract Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 263
- Locations
- 2
- Primary Endpoint
- Anterior Chamber Cell Clearing Rate
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Study Group
Single injection of DEXYCU in the treatment eye after cataract surgery.
Intervention: Dexycu (Drug)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported