Analysis of Cataract Surgery Induced Dry Eye



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2011
End Date:September 2012

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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.

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.

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.
We found this trial at
4
sites
Rockville Centre, New York 11570
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Rockville Centre, NY
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Miami, Florida 33176
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Miami, FL
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Minneapolis, Minnesota 55404
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Minneapolis, MN
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New York, New York 10021
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New York, NY
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