Prospective Health Assessment of Cataract Patients' Ocular Surface
Completed
- Conditions
- Dry Eye
- Registration Number
- NCT01016405
- Lead Sponsor
- Innovative Medical
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of dry eye as evaluated by grade on ITF (International Task Force) level. One study visit
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
The Center for Excellence in Eye Care
🇺🇸Miami, Florida, United States