Effects of Sustained Reading on the Ocular Surface

Dry Eye Syndromes Clinical Trial

Official title:

Effects of Sustained Reading on the Ocular Surface

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02031172
• Other study ID #: 00048640
• Status: Terminated
• Phase: N/A
• First received: December 2, 2013
• Last updated: August 19, 2016
• Start date: March 2014
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 89 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Sjogren's Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	To determine whether corneal sensation and corneal nerve morphology correlate with sustained reading function		30 minutes	No