- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02031172
Effects of Sustained Reading on the Ocular Surface
This research is being done to to see if changes in visual reading function correlate with changes in optical and retinal image quality. We hypothesize that changes and deterioration in tear film quality and dynamics may have a negative effect on reading function.
People with or without dry eye syndrome may enroll.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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New York
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Rochester, New York, Stati Uniti, 14642
- University of Rochester
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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
Descrizione
General inclusion criteria for all subjects will include:
- Ages 50 to 89 years
- Capacity to give informed consent.
- Self-reported literacy (i.e. a "Yes" answer to the question "Have you learned how to read?")
Additional inclusion criteria for the dry eye group will include both of the below:
- A previous diagnosis of dry eye syndrome by an eyecare specialist
- Ocular Surface Disease Index total scoring of 13 or above
Additional inclusion criteria for the Sjögren's syndrome group will include:
- A previous diagnosis of Sjögren's syndrome by an immunology specialist, per ACR criteria 22
Additional inclusion criteria for normal control subjects will include:
- No previous history of dry eye diagnosis
- Ocular Surface Disease Index total scoring of 12 or under
- Total corneal and conjunctival staining score of 0
Exclusion criteria will include:
- A binocular vision below 20/25 (with habitual correction)
- Any ocular surgery within the last 3 months.
- Mental issues, illiteracy, or language problems which might possibly interfere with reading ability
- History of taking or current use of topical prescription anti-inflammatory eyedrops (including, cyclosporine and steroids as well as any glaucoma eyedrops). Subjects who are willing to discontinue their treatment for at least a period of 30 days can be placed on a "wash out period" as per the discretion of the investigator and subject safety, and be eligible at the end of this period, given all other criteria have been met. Otherwise, subjects on these medications will be excluded.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Subjects with Dry Eye Disease
Measures tear film stability, and visual function will be taken before and after a sustained silent reading task.
The reading task will take place over 30 minutes, and a comprehension assessment will be given after reading.
After completion of the reading task, measures of corneal sensation and structural imaging will be performed.
The results from each of 3 cohorts will be compared to ascertain the differences between those populations with and without dry eye.
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Subjects with Sjogren's Syndrome
Measures tear film stability, and visual function will be taken before and after a sustained silent reading task.
The reading task will take place over 30 minutes, and a comprehension assessment will be given after reading.
After completion of the reading task, measures of corneal sensation and structural imaging will be performed.
The results from each of 3 cohorts will be compared to ascertain the differences between those populations with and without dry eye.
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Healthy Controls
Measures tear film stability, and visual function will be taken before and after a sustained silent reading task.
The reading task will take place over 30 minutes, and a comprehension assessment will be given after reading.
After completion of the reading task, measures of corneal sensation and structural imaging will be performed.
The results from each of 3 cohorts will be compared to ascertain the differences between those populations with and without dry eye.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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To see if changes in visual reading function correlate with changes in optical and retinal image quality, secondary to changes in tear film dynamics
Lasso di tempo: 30 minutes
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30 minutes
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To determine whether corneal sensation and corneal nerve morphology correlate with sustained reading function
Lasso di tempo: 30 minutes
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30 minutes
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Holly B Hindman, MD, University of Rochester, Flaum Eye Institute
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
- Processi patologici
- Malattie del sistema immunitario
- Malattie autoimmuni
- Malattie degli occhi
- Patologia
- Malattie articolari
- Malattie muscoloscheletriche
- Malattie reumatiche
- Malattie del tessuto connettivo
- Artrite
- Malattie stomatognatiche
- Malattie della bocca
- Malattie dell'apparato lacrimale
- Artrite, reumatoide
- Xerostomia
- Malattie delle ghiandole salivari
- Sindrome
- Sindromi dell'occhio secco
- Sindrome di Sjogren
Altri numeri di identificazione dello studio
- 00048640
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 .
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