Vitrectomy
Conditions
Brief summary
This study will evaluate the degree of post-operative ocular inflammation in patients who are undergoing a pars plana vitrectomy.
Interventions
PROCEDUREPars Plana Vitrectomy
Pars plana vitrectomy performed in study eye on Day 0.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Require pars plana vitrectomy in at least 1 eye * Best corrected visual acuity in the study eye between 20/400 and 20/40
Exclusion criteria
* Use of any NSAIDs (topical or systemic) within 14 days * Use of topical or systemic steroids within 30 days * Active eye infection in either eye * Any eye surgery within 6 months * Prior pars plana vitrectomy, YAG capsulotomy or uveitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Vitreous Cell Count of 0 | Week 4 | The study eye was dilated and the investigator used an instrument to count the number of visible cells in the vitreous, the jelly-like fluid that fills the back of the eye, using the following scale: 0 (no cells) best, +1 (1-10 cells), +2 (11-30 cells), +3 (31-50 cells) and +4 (\>50 cells) worst. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pars Plana Vitrectomy Pars plana vitrectomy performed in study eye on Day 0. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Pars Plana Vitrectomy |
|---|---|
| Age Continuous | 69.6 Years STANDARD_DEVIATION 10.06 |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 25 |
| serious Total, serious adverse events | 1 / 25 |
Outcome results
Primary
Percentage of Participants With Vitreous Cell Count of 0
The study eye was dilated and the investigator used an instrument to count the number of visible cells in the vitreous, the jelly-like fluid that fills the back of the eye, using the following scale: 0 (no cells) best, +1 (1-10 cells), +2 (11-30 cells), +3 (31-50 cells) and +4 (\>50 cells) worst.
Time frame: Week 4
Population: Intent to treat population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pars Plana Vitrectomy | Percentage of Participants With Vitreous Cell Count of 0 | 88.0 Percentage of participants |