Impairment of Reading Ability in Dry Eye Patients

NCT01826812 | Completed Results

• 1 other identifier: NA_00082755
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Sustained Silent Reading Speed

  30 minutes

Secondary Outcomes (4)

• Change in Total Ocular Staining Score (OSS)

  Before and after 30 minutes reading

• Change in Tear Osmolarity

  Before and after 30 minutes reading

• Change in Visual Acuity

  30 minutes

• Cytokines

  Tear samples were collected on the day of the exam. The samples were frozen to be assayed upon completion of the study.

Study Arms (2)

Dry Eye

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; Other: Dry eye exam

Controls

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; Other: Dry eye exam

Interventions

30 minutes sustained reading OTHER

The participants will be given a text to read silently in 30 minutes.

Controls; Dry Eye

Dry eye exam OTHER

Tear break-up time, tear collection, osmolarity, Schirmer test, corneal and conjunctival staining.

Controls; Dry Eye

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with known dry eye as well as normal healthy control subjects with no ocular surface diseases will be recruited from the Ocular Surface Diseases and Dry Eye Clinic as well as Glaucoma Clinic of the Wilmer Eye Institute.

You may qualify if:

• age of 50 or greater,
• literacy in English language,
• ability to give informed consent

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johns Hopkins University: lead
• Allergan: collaborator

Study Sites (1)

The Wilmer Eye Institute, Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tears

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Dr. Esen K. Akpek
• Organization: The Wilmer Eye Institute, Johns Hopkins

esakpek@jhmi.edu

410-955-5214

Study Officials

• Esen K Akpek, MD

  The Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 9, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 15, 2018
• Results First Posted: March 24, 2016

Record last verified: 2017-08

Locations

US (1)