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Effects of Sustained Reading on the Ocular Surface

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ClinicalTrials.gov Identifier: NCT02031172
Recruitment Status : Terminated (PI is moving to a different institution.)
First Posted : January 9, 2014
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):
Holly Hindman, University of Rochester

December 2, 2013
January 9, 2014
August 22, 2016
March 2014
June 2016   (Final data collection date for primary outcome measure)
  • To see if changes in visual reading function correlate with changes in optical and retinal image quality, secondary to changes in tear film dynamics [ Time Frame: 30 minutes ]
  • To determine whether corneal sensation and corneal nerve morphology correlate with sustained reading function [ Time Frame: 30 minutes ]
Change in tear film stability [ Time Frame: 30 minutes ]
To observe the change in tear film stability, thickness, volume and quality from baseline to after 30 minutes of reading.
Complete list of historical versions of study NCT02031172 on ClinicalTrials.gov Archive Site
Not Provided
Change in visual function [ Time Frame: 30 minutes ]
To observe the change in wavefront aberrations root mean square and mean transfer function from baseline to 30 minutes after of sustained silent reading.
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Effects of Sustained Reading on the Ocular Surface
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample
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.
  • Dry Eye Syndromes
  • Sjogren's Syndrome
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
34
30
June 2016
June 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years to 89 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02031172
00048640
No
Not Provided
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Holly Hindman, University of Rochester
University of Rochester
Not Provided
Principal Investigator: Holly B Hindman, MD University of Rochester, Flaum Eye Institute
University of Rochester
August 2016