Effects of Sustained Reading on the Ocular Surface

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Rochester
Sponsor:
Information provided by (Responsible Party):
Holly Hindman, University of Rochester
ClinicalTrials.gov Identifier:
NCT02031172
First received: December 2, 2013
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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.


Condition
Dry Eye Syndromes
Sjogren's Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Effects of Sustained Reading on the Ocular Surface

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To determine whether corneal sensation and corneal nerve morphology correlate with sustained reading function [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   50 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

We plan to recruit 30 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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02031172

Contacts
Contact: Christine L Callan 585-276-3426 christine_callan@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Chrys Callan    585-276-3426      
Principal Investigator: Holly B Hindman, MD         
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Holly B Hindman, MD University of Rochester, Flaum Eye Institute
  More Information

No publications provided

Responsible Party: Holly Hindman, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT02031172     History of Changes
Other Study ID Numbers: 00048640
Study First Received: December 2, 2013
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Dry Eye Disease
Sjogren's Syndrome
Tear Film
Ocular Surface
Aqueous Tear Deficiency

Additional relevant MeSH terms:
Sjogren's Syndrome
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Syndrome
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014