Impairment of Reading Ability in Dry Eye Patients

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Esen K. Akpek, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01826812
First received: April 4, 2013
Last updated: February 24, 2016
Last verified: February 2016
  Purpose
To assess the reading function impairment in patients with dry eye and to assess the effects of reading on the ocular surface.

Condition Intervention
Dry Eye Syndromes
Other: 30 minutes sustained reading
Other: Dry eye exam

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Sustained Silent Reading Speed [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Total Ocular Staining Score (OSS) [ Time Frame: Before and after 30 minutes reading ] [ Designated as safety issue: No ]
    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 [ Time Frame: Before and after 30 minutes reading ] [ Designated as safety issue: No ]
  • Change in Visual Acuity [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Cytokines [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Identification of various inflammatory cytokines in tear film of dry eye patients comparing to controls and the effect of sustained reading to the levels of these cytokines.


Biospecimen Retention:   Samples With DNA
Tears

Enrollment: 200
Study Start Date: April 2013
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Esen K. Akpek, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01826812     History of Changes
Other Study ID Numbers: NA_00082755 
Study First Received: April 4, 2013
Results First Received: January 12, 2016
Last Updated: February 24, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
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

ClinicalTrials.gov processed this record on August 22, 2016