- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01471561
Analysis of Cataract Surgery Induced Dry Eye
Retrospective Analysis of Cataract Surgery-induced Dry Eye Using Tear Osmolarity Testing
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Florida
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Miami, Florida, Stati Uniti, 33176
- William Trattler, MD
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55404
- David Hardten, MD
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New York
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New York, New York, Stati Uniti, 10021
- Chris Starr, MD
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Rockville Centre, New York, Stati Uniti, 11570
- Eric Donnenfeld, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
- Male or female, eighteen years of age or older
- Confirmed diagnosis of cataract with cataract surgery performed in at least one eye
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Post surgical tear osmolarity
Lasso di tempo: 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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Post-surgical dry eye symptoms
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Gaston Lacayo, MD
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- TP00099
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cataratta
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