Prospective Health Assessment of Cataract Patients' Ocula... | NCT01016405

Studies
Prospective Health Assessment of Cataract Patients' Ocular Surface

NCT01016405

Sponsor

Innovative Medical

Status

Completed

Last Update Posted

Feb 1, 2011Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Dry Eye

Interventions

Not provided

Countries

United States

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

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Jul 13, 2009

First Submission Date that Met QC Criteria

Nov 18, 2009

First Posted Date

Nov 19, 2009Estimated

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

Jan 31, 2011

Last Update Posted Date

Feb 1, 2011Estimated

Description Module

Brief Summary

This study will determine the incidence and severity of dry eye in patients undergoing cataract surgery as determined by grade on the International Task Force (ITF) scale.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Label	Type	Description	Intervention Names
Severity of dry eye in patients undergoing cataract surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of dry eye as evaluated by grade on ITF (International Task Force) level.		One study visit

Secondary Outcomes

Measure	Description	Time Frame
TBUT (tear break-up time), OSDI (Ocular surface disease index), corneal staining with fluorescein, conjunctival staining with lissamine, Schirmer's, and a patient questionnaire. These are all standard operations of care.		One study visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients should be at least 55 years old.
Patients must be scheduled to undergo cataract surgery.

Exclusion Criteria:

No previous intraocular surgery in the previous 3 months in either eye.
No previous Corneal laser vision correction in either eye within the last one year.
No previous lid surgery within the past 3 months.
Patients may not have used topical antibiotics, topical NSAIDs or topical steroid in either eye in the past month.
Patients are not eligible if they have recently been started on Restasis solely as a perioperative treatment regimen.
Patients presently using Restasis in either eye will not undergo any of the study testing but a questionnaire should be completed for these patients regarding use of these medications.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primary care clinic.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William Trattler, MD	The Center for Excellence in Eye Care	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Center for Excellence in Eye Care		Miami	Florida		United States

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided