Clinical Trial: Analysis of Cataract Surgery Induced Dry Eye

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Retrospective Analysis of Cataract Surgery-induced Dry Eye Using Tear Osmolarity Testing

Brief Summary: This is a retrospective study to determine if rates of osmolarity and dry eye disease symptoms increase following cataract surgery.

Detailed Summary:

The objective of this study is to determine if tear osmolarity is a good predictor for dry eye following cataract surgery.

The practice will retrospectively identify patients that have had cataract surgery from billing records. This will be cross referenced with patients that have had the diagnosis of dry eye and have had tear osmolarity testing, also from billing or electronic records analysis. The studies will be done at sites that have inclusion of a general statement about record review for research in the patient intake information at the practice. Information will be taken from the baseline visit at the final pre-operative examination prior to cataract surgery from these patients who have had tear osmolarity measured on each eye using the TearLab osmolarity device.

Because this is a retrospective study, patients will have followed each surgeon's typical pre-operative and post-operative protocol (i.e., lid cleansing, topical antibiotics, steroids, NSAIDS, etc.) without other peri-surgical complications, and followed at the normal post-operative follow-up appointments. Whenever tear osmolarity measurements had been taken and recorded in the patient's chart, this information will be collected from the patient's chart and recorded in a database. Information from visits up to and including the 3 month postoperative interval will be recorded. Additional information recorded will be demographic information such as age, corrected vision before and after the cataract surgery at the one month visit as well as at any time that tear osmolarity is measured. Additionally, any comments made in the history of present illness statement regarding dryness will be recorded in the database. Presence of other ocular surface disease present such as blepharitis, allergic disease, or anterior basement membrane dystrophy will be recorded. Sys
Sponsor: TearLab Corporation

Current Primary Outcome: Post surgical tear osmolarity [ Time Frame: 90-Day post-surgical ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Post-surgical dry eye symptoms [ Time Frame: 90-Day post-surgical ]

Original Secondary Outcome: Same as current

Information By: TearLab Corporation

Dates:
Date Received: November 10, 2011
Date Started: October 2011
Date Completion:
Last Updated: February 2, 2016
Last Verified: February 2016