Analysis of Cataract Surgery Induced Dry Eye

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
TearLab Corporation
ClinicalTrials.gov Identifier:
NCT01471561
First received: November 10, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
  Purpose

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


Condition
Cataract

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Analysis of Cataract Surgery-induced Dry Eye Using Tear Osmolarity Testing

Resource links provided by NLM:


Further study details as provided by TearLab Corporation:

Primary Outcome Measures:
  • Post surgical tear osmolarity [ Time Frame: 90-Day post-surgical ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Post-surgical dry eye symptoms [ Time Frame: 90-Day post-surgical ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 80
Study Start Date: October 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01471561

Locations
United States, Florida
William Trattler, MD
Miami, Florida, United States, 33176
United States, Minnesota
David Hardten, MD
Minneapolis, Minnesota, United States, 55404
United States, New York
Chris Starr, MD
New York, New York, United States, 10021
Eric Donnenfeld, MD
Rockville Centre, New York, United States, 11570
Sponsors and Collaborators
TearLab Corporation
Investigators
Principal Investigator: Gaston Lacayo, MD
  More Information

No publications provided

Responsible Party: TearLab Corporation
ClinicalTrials.gov Identifier: NCT01471561     History of Changes
Other Study ID Numbers: TP00099
Study First Received: November 10, 2011
Last Updated: November 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by TearLab Corporation:
Osmolarity
Cataract
Dry Eye

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014