Disorders of the Eye Following Cataract Surgery
Conditions
Keywords
cataract, prophylaxis, susceptibility
Brief summary
The purpose of the present study is to elucidate the spectrum of ocular flora and their antimicrobial susceptibility profiles in patients undergoing routine cataract surgery.
Detailed description
A conjunctival and palpebral swab will executed at least 14 days before routine cataract surgery. Isolates will be identified using standard microbiological protocols. In vitro susceptibility will be determined using a breakpoint minimal inhibitory concentrations. In case of positivity, the swab will be repeated the day of surgery. Topical antibiotic may be used in case of positivity at the discretion of the surgeon. Descriptive statistics will be calculated.
Interventions
None listed
Sponsors
SIFI SpA
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for cataract surgery * Age \> 18 years * Any gender and race * Willing to sign informed consent
Exclusion criteria
* Any antibiotics within 3 months * Any ocular infection within 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Culture in Subjects Scheduled for Cataract Surgery | At least 14 days before surgery | Number of participants with positive culture at the screening visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibiotic Susceptibility | At least 14 days before surgery | Isolated bacteria were tested for their in vitro susceptibility to commercially available ophthalmic antibiotics by the disk diffusion test and categorized as susceptible, intermediate or resistant. |
| Eradication Rate | Day of surgery | Number of participants having positive culture at the screening visit with bacterial eradication before surgery |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Group Consecutive patients scheduled for cataract surgery | 120 |
| Total | 120 |
Baseline characteristics
| Characteristic | Single Group |
|---|---|
| Age, Continuous | 72.3 years STANDARD_DEVIATION 8.4 |
| Region of Enrollment Italy | 120 participants |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 120 |
| serious Total, serious adverse events | 0 / 120 |
Outcome results
Primary
Positive Culture in Subjects Scheduled for Cataract Surgery
Number of participants with positive culture at the screening visit
Time frame: At least 14 days before surgery
Population: Number of participants with positive culture
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Group | Positive Culture in Subjects Scheduled for Cataract Surgery | 87 subjects |
Secondary
Antibiotic Susceptibility
Isolated bacteria were tested for their in vitro susceptibility to commercially available ophthalmic antibiotics by the disk diffusion test and categorized as susceptible, intermediate or resistant.
Time frame: At least 14 days before surgery
Population: Percentage of isolates susceptibility to antibiotics
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Group | Antibiotic Susceptibility | netilmicin | 94 percentage of susceptible isolates |
| Single Group | Antibiotic Susceptibility | moxifloxacin | 86 percentage of susceptible isolates |
| Single Group | Antibiotic Susceptibility | chloramphenicol | 74 percentage of susceptible isolates |
| Single Group | Antibiotic Susceptibility | levofloxacin | 70 percentage of susceptible isolates |
| Single Group | Antibiotic Susceptibility | tobramycin | 59 percentage of susceptible isolates |
| Single Group | Antibiotic Susceptibility | ofloxacin | 57 percentage of susceptible isolates |
| Single Group | Antibiotic Susceptibility | azythromycin | 15 percentage of susceptible isolates |
Secondary
Eradication Rate
Number of participants having positive culture at the screening visit with bacterial eradication before surgery
Time frame: Day of surgery
Population: Number of participants with positive culture at the screening visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Group | Eradication Rate | 80 partecipants |