Trial Outcomes & Findings for Microbiological Evaluation of the Ocular Flora Before Cataract Surgery (NCT NCT02124603)

Results Overview

Number of participants with positive culture at the screening visit

Recruitment status

COMPLETED

Target enrollment

120 participants

Primary outcome timeframe

At least 14 days before surgery

Results posted on

2016-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	Single Group Patients undergone cataract surgery
Overall Study STARTED	120
Overall Study COMPLETED	120
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Microbiological Evaluation of the Ocular Flora Before Cataract Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Group n=120 Participants Consecutive patients scheduled for cataract surgery
Age, Continuous	72.3 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Region of Enrollment Italy	120 participants n=5 Participants

PRIMARY outcome

Timeframe: At least 14 days before surgery

Population: Number of participants with positive culture

Number of participants with positive culture at the screening visit

Outcome measures

Outcome measures
Measure	Single Group n=120 Participants Patients undergone cataract surgery
Positive Culture in Subjects Scheduled for Cataract Surgery	87 subjects

SECONDARY outcome

Timeframe: At least 14 days before surgery

Population: Percentage of isolates susceptibility to antibiotics

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.

Outcome measures

Outcome measures
Measure	Single Group n=131 strains Patients undergone cataract surgery
Antibiotic Susceptibility netilmicin	94 percentage of susceptible isolates
Antibiotic Susceptibility moxifloxacin	86 percentage of susceptible isolates
Antibiotic Susceptibility chloramphenicol	74 percentage of susceptible isolates
Antibiotic Susceptibility levofloxacin	70 percentage of susceptible isolates
Antibiotic Susceptibility tobramycin	59 percentage of susceptible isolates
Antibiotic Susceptibility ofloxacin	57 percentage of susceptible isolates
Antibiotic Susceptibility azythromycin	15 percentage of susceptible isolates

SECONDARY outcome

Timeframe: Day of surgery

Population: Number of participants with positive culture at the screening visit

Number of participants having positive culture at the screening visit with bacterial eradication before surgery

Outcome measures

Outcome measures
Measure	Single Group n=87 Participants Patients undergone cataract surgery
Eradication Rate	80 partecipants

Adverse Events

Single Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Marcello Santocono

Casa di Cura Di Stefano

Phone: +393356070002

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place