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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single group | Patients undergone cataract surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Positive Culture in Subjects Scheduled for Cataract Surgery | Number of participants with positive culture at the screening visit | At least 14 days before surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At least 14 days before surgery |
| Eradication Rate |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing routine cataract surgery
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| Name | Affiliation | Role |
|---|---|---|
| Marcello Santocono, MD | Casa Di Cura Di Stefano Catania (Italy) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Casa di Cura Di Stefano | Catania | Catania | 95100 | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Group | Patients undergone cataract surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Group | Consecutive patients scheduled for cataract surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Positive Culture in Subjects Scheduled for Cataract Surgery | Number of participants with positive culture at the screening visit | Number of participants with positive culture | Posted | Number | subjects | At least 14 days before surgery |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Group | Patients to have to undergone cataract surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Marcello Santocono | Casa di Cura Di Stefano | +393356070002 | santocono.m@alice.it |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D004198 | Disease Susceptibility |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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Conjunctival and palpebral swab of the eye undergoing surgery
Number of participants having positive culture at the screening visit with bacterial eradication before surgery |
| Day of surgery |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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. | Percentage of isolates susceptibility to antibiotics | Posted | Number | percentage of susceptible isolates | At least 14 days before surgery | strains | Participants |
|
|
|
| Secondary | Eradication Rate | Number of participants having positive culture at the screening visit with bacterial eradication before surgery | Number of participants with positive culture at the screening visit | Posted | Number | partecipants | Day of surgery |
|
|
|
| 0 |
| 120 |
| 0 |
| 120 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| levofloxacin |
|
| tobramycin |
|
| ofloxacin |
|
| azythromycin |
|