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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01016405
Other study ID # 0167
Secondary ID
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


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
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