Effects of Sustained Reading on the Ocular Surface

NCT02031172 | Terminated

• 1 other identifier: 00048640
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye Syndromes; Sjogren's Syndrome

Keywords

Dry Eye Disease; Sjogren's Syndrome; Tear Film; Ocular Surface; Aqueous Tear Deficiency

Outcome Measures

Primary Outcomes (2)

• To see if changes in visual reading function correlate with changes in optical and retinal image quality, secondary to changes in tear film dynamics

  30 minutes

• To determine whether corneal sensation and corneal nerve morphology correlate with sustained reading function

  30 minutes

Study Arms (3)

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 Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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?")
• A previous diagnosis of dry eye syndrome by an eyecare specialist
• Ocular Surface Disease Index total scoring of 13 or above
• \- A previous diagnosis of Sjögren's syndrome by an immunology specialist, per ACR criteria 22
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Holly B Hindman, MD

  University of Rochester, Flaum Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: January 9, 2014
• Study Start: March 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 22, 2016

Record last verified: 2016-08

Locations

US (1)