Clinical trial NCT02031172: Effects of Sustained Reading on the Ocular Surface
Official title: Effects of Sustained Reading on the Ocular Surface
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dry Eye Syndromes
Sjogren's Syndrome
Keywords: Dry Eye Disease
Sjogren's Syndrome
Tear Film
Ocular Surface
Aqueous Tear Deficiency
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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.

Primary outcomes:
measure: To see if changes in visual reading function correlate with changes in optical and retinal image quality, secondary to changes in tear film dynamics
timeFrame: 30 minutes
measure: To determine whether corneal sensation and corneal nerve morphology correlate with sustained reading function
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester, Flaum Eye Institute
name: Holly B Hindman, MD
role: PRINCIPAL_INVESTIGATOR
References: