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Effects of Sustained Reading on the Ocular Surface

19. august 2016 opdateret af: Holly Hindman, University of Rochester

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

Afsluttet

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

34

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • New York
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 89 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

We plan to recruit 50 subjects from 3 populations (dry eye, Sjogren's, and healthy controls). Subjects will be recruited regardless of gender, race, or ethnicity; and enrollment will based on specific criteria as described below.

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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
To determine whether corneal sensation and corneal nerve morphology correlate with sustained reading function
Tidsramme: 30 minutes
30 minutes

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Holly B Hindman, MD, University of Rochester, Flaum Eye Institute

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2014

Primær færdiggørelse (Faktiske)

1. juni 2016

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

2. december 2013

Først indsendt, der opfyldte QC-kriterier

7. januar 2014

Først opslået (Skøn)

9. januar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. august 2016

Sidst verificeret

1. august 2016

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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