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OpenTrials
Completed

NCT Number: NCT01016405

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Center for Excellence in Eye Care

Miami, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of dry eye as evaluated by grade on ITF (International Task Force) level.

    Time frame: One study visit

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Innovative Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 19, 2009
Registry last updated
Feb 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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