- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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New York
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Rochester, New York, Forenede Stater, 14642
- University of Rochester
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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 undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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.
|
Hvad måler undersøgelsen?
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
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To determine whether corneal sensation and corneal nerve morphology correlate with sustained reading function
Tidsramme: 30 minutes
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30 minutes
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Holly B Hindman, MD, University of Rochester, Flaum Eye Institute
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
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Sygdomme i immunsystemet
- Autoimmune sygdomme
- Øjensygdomme
- Sygdom
- Ledsygdomme
- Muskuloskeletale sygdomme
- Reumatiske sygdomme
- Bindevævssygdomme
- Gigt
- Stomatognatiske sygdomme
- Mundsygdomme
- Sygdomme i tåreapparatet
- Gigt, reumatoid
- Xerostomi
- Spytkirtelsygdomme
- Syndrom
- Syndromer med tørre øjne
- Sjøgrens syndrom
Andre undersøgelses-id-numre
- 00048640
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