Impairment of Reading Ability in Dry Eye Patients

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Other: 30 minutes sustained reading; Other: Dry eye exam

• Registration Number: NCT01826812
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-08
• Study First Posted: 2013-04-09
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Results First Submitted: 2016-01-12
• Results First Submitted QC: 2016-02-24
• Results First Posted: 2016-03-24
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2018-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Dry eye exam	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.
Dry Eye	Dry eye exam	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.
Dry Eye	30 minutes sustained reading	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.
Controls	30 minutes sustained reading	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.

Primary Outcome Measures

Name	Time	Method
Sustained Silent Reading Speed	30 minutes

Secondary Outcome Measures

Name	Time	Method
Change in Visual Acuity	30 minutes
Change in Total Ocular Staining Score (OSS)	Before and after 30 minutes reading	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.
Change in Tear Osmolarity	Before and after 30 minutes reading
Cytokines	Tear samples were collected on the day of the exam. The samples were frozen to be assayed upon completion of the study.	Identification of various inflammatory cytokines in tear film of dry eye patients comparing to controls.

Trial Locations

Locations (1)

The Wilmer Eye Institute, Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States