- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01471561
Analysis of Cataract Surgery Induced Dry Eye
Retrospective Analysis of Cataract Surgery-induced Dry Eye Using Tear Osmolarity Testing
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Florida
-
Miami, Florida, Forenede Stater, 33176
- William Trattler, MD
-
-
Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55404
- David Hardten, MD
-
-
New York
-
New York, New York, Forenede Stater, 10021
- Chris Starr, MD
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Rockville Centre, New York, Forenede Stater, 11570
- Eric Donnenfeld, MD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
- Male or female, eighteen years of age or older
- Confirmed diagnosis of cataract with cataract surgery performed in at least one eye
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Post surgical tear osmolarity
Tidsramme: 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 |
90-Day post-surgical
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Post-surgical dry eye symptoms
Tidsramme: 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 |
90-Day post-surgical
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Gaston Lacayo, MD
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TP00099
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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