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Impairment of Reading Ability in Dry Eye Patients

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ClinicalTrials.gov Identifier: NCT01826812
Recruitment Status : Completed
First Posted : April 9, 2013
Results First Posted : March 24, 2016
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Dry Eye Syndromes 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
Actual Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Functional Impairment of Reading Ability in Dry Eye Patients and Effects of Sustained Reading on the Ocular Surface
Study Start Date : April 2013
Primary Completion Date : November 2015
Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Sustained Silent Reading Speed [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. Change in Total Ocular Staining Score (OSS) [ Time Frame: 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.

  2. Change in Tear Osmolarity [ Time Frame: Before and after 30 minutes reading ]
  3. Change in Visual Acuity [ Time Frame: 30 minutes ]
  4. Cytokines [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Tears


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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826812


Locations
United States, Maryland
The Wilmer Eye Institute, Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Allergan
Investigators
Principal Investigator: Esen K Akpek, MD The Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01826812     History of Changes
Other Study ID Numbers: NA_00082755
First Posted: April 9, 2013    Key Record Dates
Results First Posted: March 24, 2016
Last Update Posted: February 15, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases