Cataract
Conditions
Keywords
DEXYCU, Cataract, dexamethasone intraocular suspension
Brief summary
Retrospective study to provide clinical outcomes with DEXYCU (dexamethasone intraocular suspension) 9%.
Detailed description
This retrospective study is intended to provide large-scale, real-world data on clinical outcomes with DEXYCU (dexamethasone intraocular suspension) 9%.
Interventions
DRUGDEXYCU (dexamethasone intraocular suspension) 9%.
DEXYCU contains dexamethasone 9% w/w (103.4 mg/mL) as a sterile suspension for intraocular ophthalmic administration. DEXYCU is provided as a kit for administration of a single dose of 0.005 mL of 9% dexamethasone (equivalent to 517 micrograms of dexamethasone).
Sponsors
EyePoint Pharmaceuticals, Inc.
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and Female subjects at least 18 years of age * Subjects who underwent cataract surgery from 12Mar2019 to 15Dec2019 and received DEXYCU
Exclusion criteria
• Subjects who underwent cataract surgery and did not receive DEXYCU
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With Anterior Chamber Cell Grade 0 | Postoperative day 8 | Of eyes with a record at postoperative day 8, percentage with anterior chamber cell grade 0. Cells in the anterior chamber of the eye are indicative of intraocular inflammation and are evaluated using a slit-lamp biomicroscope; a grade of 0 indicates that no inflammatory cells were visible in a 1 mm by 1 mm slit beam. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DEXYCU (Dexamethasone Intraocular Suspension) 9% All participants received DEXYCU (dexamethasone intraocular suspension) 9% as a single dose, administered intraocularly into the posterior chamber at the end of surgery. | 527 |
| DEXYCU (Dexamethasone Intraocular Suspension) 9% All participants received DEXYCU (dexamethasone intraocular suspension) 9% as a single dose, administered intraocularly into the posterior chamber at the end of surgery. | 641 |
| Total | 1,168 |
Baseline characteristics
| Characteristic | DEXYCU (Dexamethasone Intraocular Suspension) 9% |
|---|---|
| Age, Continuous | 71.5 years STANDARD_DEVIATION 8.35 |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 74 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 327 Participants |
| Race/Ethnicity, Customized Ethnicity Not Reported | 100 Participants |
| Race/Ethnicity, Customized Ethnicity Unknown | 26 Participants |
| Sex: Female, Male Female | 308 Participants |
| Sex: Female, Male Male | 219 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 527 |
| other Total, other adverse events | 20 / 527 |
| serious Total, serious adverse events | 0 / 527 |
Outcome results
Primary
Percentage of Eyes With Anterior Chamber Cell Grade 0
Of eyes with a record at postoperative day 8, percentage with anterior chamber cell grade 0. Cells in the anterior chamber of the eye are indicative of intraocular inflammation and are evaluated using a slit-lamp biomicroscope; a grade of 0 indicates that no inflammatory cells were visible in a 1 mm by 1 mm slit beam.
Time frame: Postoperative day 8
Population: eyes with a record at postoperative day 8
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DEXYCU (Dexamethasone Intraocular Suspension) 9% | Percentage of Eyes With Anterior Chamber Cell Grade 0 | 65 percentage of eyes |