Prospective Health Assessment of Cataract Patients' Ocular Surface

Sponsor

Innovative Medical (Industry)

Overall Status

Completed

CT.gov ID

NCT01016405

Collaborator

(none)

200

Enrollment

Location

Duration (Months)

13.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Severity of dry eye in patients undergoing cataract surgery

Outcome Measures

Primary Outcome Measures

Incidence of dry eye as evaluated by grade on ITF (International Task Force) level. [One study visit]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.