Analysis of Cataract Surgery Induced Dry Eye

Sponsor
TearLab Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01471561
Collaborator
(none)
61
Enrollment
4
Locations
11
Duration (Months)
15.3
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    61 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Retrospective Analysis of Cataract Surgery-induced Dry Eye Using Tear Osmolarity Testing
    Study Start Date :
    Oct 1, 2011
    Actual Primary Completion Date :
    Sep 1, 2012
    Actual Study Completion Date :
    Sep 1, 2012

    Outcome Measures

    Primary Outcome Measures

    1. Post surgical tear osmolarity [90-Day post-surgical]

      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

    1. Post-surgical dry eye symptoms [90-Day post-surgical]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    SiteCityStateCountryPostal Code
    1William Trattler, MDMiamiFloridaUnited States33176
    2David Hardten, MDMinneapolisMinnesotaUnited States55404
    3Chris Starr, MDNew YorkNew YorkUnited States10021
    4Eric Donnenfeld, MDRockville CentreNew YorkUnited States11570

    Sponsors and Collaborators

    • TearLab Corporation

    Investigators

    • Principal Investigator: Gaston Lacayo, MD,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TearLab Corporation
    ClinicalTrials.gov Identifier:
    NCT01471561
    Other Study ID Numbers:
    • TP00099
    First Posted:
    Nov 16, 2011
    Last Update Posted:
    Feb 4, 2016
    Last Verified:
    Feb 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by TearLab Corporation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 4, 2016