Analysis of Cataract Surgery Induced Dry Eye

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

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

Study Overview

• Status: Completed
• Conditions: Cataract

Detailed Description

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. Systemic medications that the patient is taking will also be recorded. Presence or absence of diabetes mellitus will also be recorded. The database will be kept in a password protected computer in a locked office location, and every precaution will be taken to prevent identification of any patient specific identifiers. Information will be de-identified as soon as possible by using codes to identify the data rather than patient names or chart numbers.

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33176
      • William Trattler, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • David Hardten, MD
  • New York
    • New York, New York, United States, 10021
      • Chris Starr, MD
    • Rockville Centre, New York, United States, 11570
      • Eric Donnenfeld, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1. Male or female, eighteen years of age or older
2. Confirmed diagnosis of cataract with cataract surgery performed in at least one eye

Description

Inclusion Criteria:

1. Male or female, eighteen years of age or older
2. Confirmed diagnosis of cataract with cataract surgery performed in at least one eye

Exclusion Criteria:

1. Any complications of cataract surgery that have required a sclera incision rather than a clear corneal incision.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post surgical tear osmolarity	Correlation between pre-surgery value and development of dry eye disease post surgery 1) Comparison of Osmolarity measurement pre to post-op, as well as over time, to determine change and statistical significance	90-Day post-surgical

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-surgical dry eye symptoms	Correlation between pre-surgery value and development of dry eye disease post surgery. 1) Subjective patient reporting on dry eye symptoms from pre to postoperative	90-Day post-surgical

Collaborators and Investigators

• Sponsor: TearLab Corporation
• Investigators: Principal Investigator: Gaston Lacayo, MD

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: November 10, 2011
• First Submitted That Met QC Criteria: November 10, 2011
• First Posted (Estimate): November 16, 2011

Study Record Updates

• Last Update Posted (Estimate): February 4, 2016
• Last Update Submitted That Met QC Criteria: February 2, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Cataract; Dry Eye; Osmolarity
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Lacrimal Apparatus Diseases; Cataract; Dry Eye Syndromes
• Other Study ID Numbers: TP00099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No data will be shared.