Impairment of Reading Ability in Dry Eye Patients

Study Overview
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Brief Summary
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To assess the reading function impairment in patients with dry eye and to assess the effects of reading on the ocular surface.

Detailed Description
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This study is being done to understand how reading is affected in people with dry eye in comparison with healthy controls and what effect reading has on the ocular surface in patients with dry eye.

Official Title
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Functional Impairment of Reading Ability in Dry Eye Patients and Effects of Sustained Reading on the Ocular Surface

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Other: 30 minutes sustained reading
* Other: Dry eye exam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age of 50 or greater, literacy in English language, ability to give informed consent Exclusion Criteria: binocular vision below 20/25, any ocular surgery within the last 3 months, mental issues, illiteracy, language problems which might possibly interfere with reading ability, history of taking or current use of topical prescription anti-inflammatory eye drops (including, cyclosporine and steroids as well as any glaucoma eye drops).

Ages Eligible for Study
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Minimum Age: 50 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 |
| --- | --- |
| Dry Eye<br>The patients with Sjogren Syndrome related or non-Sjogren Syndrome related dry eye. The participants will be asked some questions. Before and after reading a text silently in 30 minutes 30 minutes sustained reading, a detailed dry eye exam will be performed. | Other: 30 minutes sustained reading<br>* The participants will be given a text to read silently in 30 minutes.<br>Other: Dry eye exam<br>* Tear break-up time, tear collection, osmolarity, Schirmer test, corneal and conjunctival staining.<br>|
| Controls<br>The patients without dry eye. The participants will be asked some questions. Before and after reading a text silently in 30 minutes 30 minutes sustained reading, a detailed dry eye exam will be performed. | Other: 30 minutes sustained reading<br>* The participants will be given a text to read silently in 30 minutes.<br>Other: Dry eye exam<br>* Tear break-up time, tear collection, osmolarity, Schirmer test, corneal and conjunctival staining.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Silent Reading Speed |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Ocular Staining Score (OSS) | Ocular staining score (OSS) is sum of the corneal and conjuctival staining scores with a total possible maximum score of 12 for each eye. Corneal staining is graded with a maximum possible fluorescein score of 6 for each cornea (the punctate epithelial erosions grade between 0-3 plus any extra points for modifiers up to 3). Nasal and temporal conjunctiva are graded separately with a score range between 0 and 3 for each area after instillation of lissamine green. An abnormal OSS is defined as being a total score of 3 or more. | Before and after 30 minutes reading | 
| Change in Tear Osmolarity |  | Before and after 30 minutes reading | 
| Change in Visual Acuity |  | 30 minutes | 
| Cytokines | Identification of various inflammatory cytokines in tear film of dry eye patients comparing to controls. | Tear samples were collected on the day of the exam. The samples were frozen to be assayed upon completion of the study. |