NCT02124603

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
12 months until next milestone

Results Posted

Study results publicly available

September 29, 2015

Completed
Last Updated

January 18, 2016

Status Verified

December 1, 2015

Enrollment Period

6 months

First QC Date

April 23, 2014

Results QC Date

July 20, 2015

Last Update Submit

December 15, 2015

Conditions

Disorders of the Eye Following Cataract Surgery

Keywords

cataractprophylaxissusceptibility

Outcome Measures

Primary Outcomes (1)

  • Positive Culture in Subjects Scheduled for Cataract Surgery

    Number of participants with positive culture at the screening visit

    At least 14 days before surgery

Secondary Outcomes (2)

  • Antibiotic Susceptibility

    At least 14 days before surgery

  • Eradication Rate

    Day of surgery

Study Arms (1)

single group

Patients undergone cataract surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing routine cataract surgery

You may qualify if:

  • Patients scheduled for cataract surgery
  • Age \> 18 years
  • Any gender and race
  • Willing to sign informed consent

You may not qualify if:

  • Any antibiotics within 3 months
  • Any ocular infection within 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Casa di Cura Di Stefano

Catania, Catania, 95100, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Conjunctival and palpebral swab of the eye undergoing surgery

MeSH Terms

Conditions

CataractDisease Susceptibility

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr.Marcello Santocono
Organization
Casa di Cura Di Stefano
santocono.m@alice.it
+393356070002

Study Officials

  • Marcello Santocono, MD

    Casa Di Cura Di Stefano Catania (Italy)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2014

First Posted

April 28, 2014

Study Start

April 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

January 18, 2016

Results First Posted

September 29, 2015

Record last verified: 2015-12

Locations

IT(1)