A Real-world Study of DEXYCU in the Treatment of Inflammation After Cataract Surgery
- Conditions
- InflammationCataract
- Interventions
- Drug: Dexycu
- Registration Number
- NCT06497699
- Lead Sponsor
- Ocumension Therapeutics (Shanghai) Co., Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 263
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Group Dexycu Single injection of DEXYCU in the treatment eye after cataract surgery.
- Primary Outcome Measures
Name Time Method Anterior chamber cell clearing rate 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 Outcome Measures
Name Time Method Anterior chamber flare clearing rates DAY 1 & 8 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).Change in central macular thickness DAY 1 & 8 Compare the change in central macula thickness at Day 1 and 8 of the Dexycu group and external control group.
Anterior chamber cell clearing rates DAY 1 & 30 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).Mean anterior chamber cell score DAY 1 & 8 & 30 Compare the mean score of anterior chamber cell at Day 1 , 8 and 30 of the Dexycu group and external control group.
Mean anterior chamber flare score DAY 1 & 8 & 30 Compare the mean score of anterior chamber flare at Day 1, 8 and 30 of the Dexycu group and external control group.
Evaluate the ease of use of the Dexycu ejector DAY 0 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.
Change in vision DAY 1 & 8 & 30 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.
Trial Locations
- Locations (2)
Boao Super Hospital
🇨🇳Bo'ao, China
Hainan Traditional Chinese Medicine Hospital
🇨🇳Haikou, Hainan, China