Analysis of Cataract Surgery Induced Dry Eye

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471561
• Other study ID #: TP00099
• Status: Completed
• Phase: N/A
• First received: November 10, 2011
• Last updated: February 2, 2016
• Start date: October 2011
• Est. completion date: September 2012

Study information

• Verified date: February 2016
• Source: TearLab Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cataract

Locations

Country	Name	City	State
United States	William Trattler, MD	Miami	Florida
United States	David Hardten, MD	Minneapolis	Minnesota
United States	Chris Starr, MD	New York	New York
United States	Eric Donnenfeld, MD	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
TearLab Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No