Intravitreous, Injections
Conditions
Brief summary
Evaluation of efficacy of topical preoperative antibiotics in patients undergoing intravitreous injections.
Interventions
DRUGgatifloxacin
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* intravitreous injection
Exclusion criteria
* antibiotic use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Culture | Study day 1, assessed following administration of study treatment | The percentage of patients with a positive bacterial culture following administration of study treatment is presented. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Topical Antibiotic topical gatifloxacin 4 times per day
gatifloxacin | 129 |
| Total | 129 |
Baseline characteristics
| Characteristic | Topical Antibiotic |
|---|---|
| Age, Continuous | 77 years STANDARD_DEVIATION 13 |
| Conjunctival Bacterial Flora Coagulase-negative staphylococcus | 75 percentage of patients |
| Conjunctival Bacterial Flora Gram-negative rods | 6 percentage of patients |
| Conjunctival Bacterial Flora Staphylococcus aureus | 7 percentage of patients |
| Conjunctival Bacterial Flora Streptococcus species | 7 percentage of patients |
| Sex: Female, Male Female | 81 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 129 |
| serious Total, serious adverse events | 0 / 129 |
Outcome results
Primary
Positive Culture
The percentage of patients with a positive bacterial culture following administration of study treatment is presented.
Time frame: Study day 1, assessed following administration of study treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topical Antibiotic | Positive Culture | 8 percentage of patients |