Prospective Health Assessment of Cataract Patients' Ocular Surface

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01016405
• Other study ID #: 0167
• Status: Completed
• Phase: N/A
• First received: July 13, 2009
• Last updated: January 31, 2011
• Start date: June 2009
• Est. completion date: September 2010

Study information

• Verified date: January 2011
• Source: Innovative Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cataract
• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Locations

Country	Name	City	State
United States	The Center for Excellence in Eye Care	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dry eye as evaluated by grade on ITF (International Task Force) level.		One study visit	No
Secondary	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	No