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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
  Purpose

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
Dry Eye

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cataract and Dry Eye The PHACO Study (Prospective Health Assessment of Cataract Patients' Ocular Surface)

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Incidence of dry eye as evaluated by grade on ITF (International Task Force) level. [ Time Frame: One study visit ] [ Designated as safety issue: No ]

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. [ Time Frame: One study visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Severity of dry eye in patients undergoing cataract surgery

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016405

Locations
United States, Florida
The Center for Excellence in Eye Care
Miami, Florida, United States
Sponsors and Collaborators
Innovative Medical
Investigators
Principal Investigator: William Trattler, MD The Center for Excellence in Eye Care
  More Information

No publications provided

Responsible Party: William Trattler, M.D, The Center for Excellence in Eye Care
ClinicalTrials.gov Identifier: NCT01016405     History of Changes
Other Study ID Numbers: 0167
Study First Received: July 13, 2009
Last Updated: January 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Innovative Medical:
Dry eye
incidence and severity
cataract surgery

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Cataract
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
 Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Lens Diseases

ClinicalTrials.gov processed this record on May 16, 2013