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- Klinische proef NCT01471561
Analysis of Cataract Surgery Induced Dry Eye
Retrospective Analysis of Cataract Surgery-induced Dry Eye Using Tear Osmolarity Testing
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Florida
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Miami, Florida, Verenigde Staten, 33176
- William Trattler, MD
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55404
- David Hardten, MD
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New York
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New York, New York, Verenigde Staten, 10021
- Chris Starr, MD
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Rockville Centre, New York, Verenigde Staten, 11570
- Eric Donnenfeld, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
- Male or female, eighteen years of age or older
- Confirmed diagnosis of cataract with cataract surgery performed in at least one eye
Beschrijving
Inclusion Criteria:
- Male or female, eighteen years of age or older
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Post surgical tear osmolarity
Tijdsspanne: 90-Day post-surgical
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Post-surgical dry eye symptoms
Tijdsspanne: 90-Day post-surgical
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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
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Gaston Lacayo, MD
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TP00099
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Staar
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Colvard Kandavel Eye CenterAanmelden op uitnodigingStaar | Cataract Bilateraal | Cataract Chirurgie | Cataract (Follow-up na Cataractchirurgie)Verenigde Staten
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Matthew RauenNog niet aan het wervenNucleaire cataract | Cataract Chirurgie Anesthesie | Cataract en IOL-chirurgie | Ervaring met cataractchirurgieVerenigde Staten
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Stanford UniversityAanmelden op uitnodigingIntraoculaire lens | Cataract extractie | Cataract Chirurgie | Oogaandoeningen | Cataract en IOL-chirurgie | Ervaring met cataractchirurgieVerenigde Staten
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Züleyha SönmezAtaturk UniversityActief, niet wervendCataract Chirurgie | Cataractpatiënten | Cataract Na OperatieTurkije (Türkiye)
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Fundación Pública Andaluza para la Investigación...VoltooidStaar | Cataract volwassen | Cataract, nucleair
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Gemini Eye ClinicWervingBilaterale cataract | Eenzijdige cataractTsjechië
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Johannes Kepler University of LinzVoltooidCataract ingewikkeld | Cataract Complicaties OperatiesOostenrijk
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Fondation Ophtalmologique Adolphe de RothschildWervingCataract Bilateraal | Bilaterale cataract | Bilaterale cataractFrankrijk
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Centre hospitalier de l'Université de Montréal...Nog niet aan het wervenStaar | Cataract Bilateraal | Cataract Chirurgie
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Sohag UniversityNog niet aan het werven