Effects of Sustained Reading on the Ocular Surface

NCT ID: NCT02031172

Last Updated: 2016-08-22

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-06-30

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Holly Hindman

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Holly B Hindman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester, Flaum Eye Institute

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

00048640

Identifier Type: -

Identifier Source: org_study_id