Effects of Sustained Reading on the Ocular Surface

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Sustained Reading on the Ocular Surface

Conditions
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Dry Eye Syndromes, Sjogren's Syndrome

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with Dry Eye Disease<br>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<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye Disease, Sjogren's Syndrome, Tear Film, Ocular Surface, Aqueous Tear Deficiency