Inflammation, Cataract
Conditions
Keywords
Cataract Surgery, Postoperative Inflammation
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.
Interventions
DRUGDexycu
single injection,5ul solution,concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone
Sponsors
Ocumension Therapeutics (Shanghai) Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Study group:Dexycu interventional group External control group;without intervention
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China
Participant flow
Recruitment details
113 recruited to the study group treat with DEXYCU postsurgerically. 150 recruited to control group which observation study was conducted.
Participants by arm
| Arm | Count |
|---|---|
| Control Group The clinical routine treatment after cataract surgery was adopted without intervention | 150 |
| Study Group Single injection of DEXYCU in the treatment eye after cataract surgery.
Dexycu: single injection,5ul solution,concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone | 113 |
| Total | 263 |
Baseline characteristics
| Characteristic | Control Group | Study Group | Total |
|---|---|---|---|
| Age, Customized < = 60 years | 15 Participants | 17 Participants | 32 Participants |
| Age, Customized > 60 years | 135 Participants | 96 Participants | 231 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 150 Participants | 113 Participants | 263 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 149 participants | 113 participants | 262 participants |
| Sex: Female, Male Female | 84 Participants | 55 Participants | 139 Participants |
| Sex: Female, Male Male | 66 Participants | 58 Participants | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 150 | 1 / 113 |
| other Total, other adverse events | 14 / 150 | 15 / 113 |
| serious Total, serious adverse events | 5 / 150 | 1 / 113 |
Outcome results
Primary
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).
Time frame: DAY 8
Population: 1 control group participant loss to follow up before reaching DAY 8.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Anterior Chamber Cell Clearing Rate | 119 Participants |
| Study Group | Anterior Chamber Cell Clearing Rate | 95 Participants |