- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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New York
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Rochester, New York, Forente stater, 14642
- University of Rochester
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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.
|
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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To see if changes in visual reading function correlate with changes in optical and retinal image quality, secondary to changes in tear film dynamics
Tidsramme: 30 minutes
|
30 minutes
|
To determine whether corneal sensation and corneal nerve morphology correlate with sustained reading function
Tidsramme: 30 minutes
|
30 minutes
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Holly B Hindman, MD, University of Rochester, Flaum Eye Institute
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Sykdommer i immunsystemet
- Autoimmune sykdommer
- Øyesykdommer
- Sykdom
- Leddsykdommer
- Muskel- og skjelettsykdommer
- Revmatiske sykdommer
- Bindevevssykdommer
- Leddgikt
- Stomatognatiske sykdommer
- Munnsykdommer
- Tåreapparatsykdommer
- Leddgikt, revmatoid
- Xerostomi
- Spyttkjertelsykdommer
- Syndrom
- Syndromer med tørre øyne
- Sjøgrens syndrom
Andre studie-ID-numre
- 00048640
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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