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Prospective Health Assessment of Cataract Patients' Ocular Surface

This study has been completed.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01016405
First received: July 13, 2009
Last updated: January 31, 2011
Last verified: January 2011
History of Changes

July 13, 2009
January 31, 2011
June 2009
September 2010   (final data collection date for primary outcome measure)
Incidence of dry eye as evaluated by grade on ITF (International Task Force) level. [ Time Frame: One study visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01016405 on ClinicalTrials.gov Archive Site
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. [ Time Frame: One study visit ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prospective Health Assessment of Cataract Patients' Ocular Surface
Cataract and Dry Eye The PHACO Study (Prospective Health Assessment of Cataract Patients' Ocular Surface)

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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Primary care clinic.
Dry Eye
Not Provided
Severity of dry eye in patients undergoing cataract surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01016405
0167
Not Provided
William Trattler, M.D, The Center for Excellence in Eye Care
Innovative Medical
Not Provided
Principal Investigator: William Trattler, MD The Center for Excellence in Eye Care
Innovative Medical
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP