Cataract and Dry Eye The PHACO Study (Prospective Health Assessment of Cataract Patients' Ocular Surface)

Innovative Medical1 site in 1 country200 target enrollmentJune 2009

ConditionsDry Eye

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dry Eye
Sponsor: Innovative Medical
Enrollment: 200
Locations: 1
Primary Endpoint: Incidence of dry eye as evaluated by grade on ITF (International Task Force) level.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

September 2010

Last Updated

15 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Innovative Medical

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.

Outcomes

Primary Outcomes

Incidence of dry eye as evaluated by grade on ITF (International Task Force) level.

Time Frame: One study visit

Secondary Outcomes

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)