Impairment of Reading Ability in Dry Eye Patients

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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Other: 30 minutes sustained reading; Other: Dry eye exam

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Wilmer Eye Institute, Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The participants will be given a text to read silently in 30 minutes.; Other: Dry eye exam; Tear break-up time, tear collection, osmolarity, Schirmer test, corneal and conjunctival staining.
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; The participants will be given a text to read silently in 30 minutes.; Other: Dry eye exam; Tear break-up time, tear collection, osmolarity, Schirmer test, corneal and conjunctival staining.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Allergan
• Investigators: Principal Investigator: Esen K Akpek, MD, The Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: April 4, 2013
• First Submitted That Met QC Criteria: April 8, 2013
• First Posted (Estimate): April 9, 2013

Study Record Updates

• Last Update Posted (Actual): February 15, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: NA_00082755

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED