Cataract
Conditions
Brief summary
Topical fluoroquinolones (FQs) have achieved widespread use in ophthalmology for both the treatment and prophylaxis of ocular infections. The present study is set to determine the bacteria present on the ocular surface in patients at the time of cataract surgery and to assess the rate of resistance of ocular isolates to commonly used topical antibiotics.
Interventions
None listed
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled to undergo cataract surgery * Able to provide written informed consent
Exclusion criteria
* NSAID in the eye to be swabbed within the past 30 days * Topical anesthetic, topical antibiotic or antiseptic, or dilating drops in the eye to the swabbed within the past 7 days * Over-the-counter artificial tear drops or astringent /redness reliever drops (e.g., Visine®, Clear eyes® in the eye to be swabbed on the day of trial * History of conjunctivitis or any ocular infection within the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid | Baseline | Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were \<= 0.25 ug/ml (susceptible) and \>= 0.50 ug/ml (resistant). |
| Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva | Baseline | Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the conjunctiva . The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were \<= 0.25 ug/ml (susceptible) and \>= 0.50 ug/ml (resistant). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid | Baseline | Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were \<= 2 ug/ml (susceptible) and \>= 4 ug/ml (resistant). |
| Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Conjunctiva | Baseline | Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the conjunctiva. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were \<= 2 ug/ml (susceptible) and \>= 4 ug/ml (resistant). |
Countries
United States
Participant flow
Pre-assignment details
This was a culture swab study at a single time-point. No medications were administered and patients were not followed beyond the initial culture.
Participants by arm
| Arm | Count |
|---|---|
| All Patients All patients receiving cataract surgery | 399 |
| Total | 399 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Customized < 50 years | 6 participants |
| Age, Customized Between 50 and 59 years | 61 participants |
| Age, Customized Between 60 and 69 years | 126 participants |
| Age, Customized Between 70 and 79 years | 138 participants |
| Age, Customized Between 80 and 89 years | 60 participants |
| Age, Customized Between 90 and 99 years | 8 participants |
| Sex: Female, Male Female | 224 Participants |
| Sex: Female, Male Male | 175 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva
Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the conjunctiva . The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were \<= 0.25 ug/ml (susceptible) and \>= 0.50 ug/ml (resistant).
Time frame: Baseline
Population: ITT population. All patients with cultures performed of the ocular surface.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva | Percentage of Species Oxacillin-Susceptible | 52 Percentage of Species |
| All Patients | Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva | Percentage of Species Oxacillin-Resistant | 45 Percentage of Species |
Primary
Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid
Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were \<= 0.25 ug/ml (susceptible) and \>= 0.50 ug/ml (resistant).
Time frame: Baseline
Population: ITT population. All patients with cultures performed of the ocular surface.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid | Percentage of Species Oxacillin-Susceptible | 51 Percentage of Species |
| All Patients | Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid | Percentage of Species Oxacillin-Resistant | 48 Percentage of Species |
Secondary
Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Conjunctiva
Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the conjunctiva. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were \<= 2 ug/ml (susceptible) and \>= 4 ug/ml (resistant).
Time frame: Baseline
Population: ITT population. All patients with cultures performed of the ocular surface.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Conjunctiva | Percentage of Species Oxacillin-Susceptible | 70 Percentage of Species |
| All Patients | Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Conjunctiva | Percentage of Species Oxacillin-Resistant | 21 Percentage of Species |
Secondary
Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid
Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were \<= 2 ug/ml (susceptible) and \>= 4 ug/ml (resistant).
Time frame: Baseline
Population: ITT population. All patients with cultures performed of the ocular surface.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid | Percentage of Species Oxacillin-Susceptible | 59 Percentage of Species |
| All Patients | Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid | Percentage of Species Oxacillin-Resistant | 34 Percentage of Species |