Impairment of Reading Ability in Dry Eye Patients

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826812
• Other study ID #: NA_00082755
• Status: Completed
• Phase: N/A
• First received: April 4, 2013
• Last updated: August 16, 2017
• Start date: April 2013
• Est. completion date: November 2015

Study information

• Verified date: August 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Other:
• 30 minutes sustained reading
The participants will be given a text to read silently in 30 minutes.
• Dry eye exam
Tear break-up time, tear collection, osmolarity, Schirmer test, corneal and conjunctival staining.

Locations

Country	Name	City	State
United States	The Wilmer Eye Institute, Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Silent Reading Speed		30 minutes
Secondary	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
Secondary	Change in Tear Osmolarity		Before and after 30 minutes reading
Secondary	Change in Visual Acuity		30 minutes
Secondary	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.