Are Corneal Epithelial Defects Related to Changes in Ocul... | NCT02234700

Studies
Are Corneal Epithelial Defects Related to Changes in Ocular Bacterial Flora in Patients With ANLDO

NCT02234700

Sponsor

Western Galilee Hospital-Nahariya

Status

Unknown status

Last Update Posted

Sep 9, 2014Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Acquired Nasolacrimal Duct Obstruction

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Feb 2015Estimated

Completion Date

Feb 2015Estimated

First Submitted Date

Aug 26, 2014

First Submission Date that Met QC Criteria

Sep 8, 2014

First Posted Date

Sep 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2014

Last Update Posted Date

Sep 9, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Comparison between patients with nasolacrimal duct obstruction and healthy patients and the influence of their bacterial flora on the corneal epithelium.

Detailed Description

Any patient with nasolacrimal duct obstruction above the age of 18 Comparing changes in their bacterial ocular flora to healthy patients without obstruction and above 18 years of age

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the change of ocular normal flora in patients with nasolacrimal duct obstruction as a comparison to general population.	as the literature suggests most of the ocular flora is composed of Staphylococcus and Haemophilus, any change in these composition will be considered abnormal.	6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or older, nasolacrimal duct obstruction

Exclusion Criteria:

younger then 18 years of age
ocular infections
patients after repair of lacrimal duct surgery
systemic active diseases
patients taking medication that are know to influence bacterial flora of the eye

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

30 patients with nasolacrimal duct obstruction and 30 healthy patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
abdelhakim Ayub, MD	Contact	0502999110		abedayub@gmail.com

Overall Officials

Name	Affiliation	Role
Yanir Kassif, M.D	Medical Center of the Galilee	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Western Galileeh Hospital	Recruiting	Naharya		22402	Israel