An observational study in Disorders of the Eye Following Cataract Surgery, sponsored by SIFI SpA. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-18.
Sponsored by SIFI SpA · Observational
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.
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 120 is above the median of 81 across 484 observational studies indexed under Cataract.
Browse Cataract studies →SIFI SpA is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing routine cataract surgery
Exclusion Criteria:
Patients undergone cataract surgery
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
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
Eradication Rate
Number of participants having positive culture at the screening visit with bacterial eradication before surgery
Time frame: Day of surgery
| Milestone | Single Group |
|---|---|
| Started | 120 |
| Completed | 120 |
| Not completed | 0 |
Number of participants with positive culture at the screening visit
| subjects | Single Group |
|---|---|
| Positive Culture in Subjects Scheduled for Cataract Surgery | 87 |
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.
| percentage of susceptible isolates | Single Group |
|---|---|
| netilmicin | 94 |
| moxifloxacin | 86 |
| chloramphenicol | 74 |
| levofloxacin | 70 |
| tobramycin | 59 |
| ofloxacin | 57 |
| azythromycin | 15 |
Number of participants having positive culture at the screening visit with bacterial eradication before surgery
| partecipants | Single Group |
|---|---|
| Eradication Rate | 80 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Group | — | 0/120 (0%) | 0/120 (0%) |
| Age, Continuous(years) | Single Group |
|---|---|
| Mean | 72.3 ± 8.4 |
| Sex: Female, Male(Participants) | Single Group |
|---|---|
| Female | 71 |
| Male | 49 |
| Region of Enrollment(participants) | Single Group |
|---|---|
| Italy | 120 |
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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SIFI SpA