Impairment of Reading Ability in Dry Eye Patients

NCT ID: NCT01826812

Last Updated: 2018-02-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Dry Eye Syndromes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

30 minutes sustained reading

Intervention Type OTHER

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

Dry eye exam

Intervention Type OTHER

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.

30 minutes sustained reading

Intervention Type OTHER

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

Dry eye exam

Intervention Type OTHER

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

Interventions

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30 minutes sustained reading

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

Intervention Type OTHER

Dry eye exam

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

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Allergan

INDUSTRY

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Esen K Akpek, MD

Role: PRINCIPAL_INVESTIGATOR

The Johns Hopkins University

Locations

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The Wilmer Eye Institute, Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA_00082755

Identifier Type: -

Identifier Source: org_study_id

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