Effects of Sustained Reading on the Ocular Surface

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02031172

Enrollment

Registered

2014-01-09

Start date

2014-03-31

Completion date

2016-06-30

Last updated

2016-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes, Sjogren's Syndrome

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

50 Years to 89 Years

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results