Trial record 15 of 84 for:    Open Studies | "Lacrimal Apparatus Diseases"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Johns Hopkins University
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: April 8, 2013
Last verified: April 2013
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Reading Speed [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Do individuals with dry eye have impaired sustained silent reading function when compared to controls?


Secondary Outcome Measures:
  • Ocular Surface Score [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Is there a change in the Ocular Surface Score with reading as a stressor in patients with dry eye compared to controls?

  • Tear Osmolarity [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Is there a change in osmolarity with reading as a stressor in patients with dry eye comparing to controls?

  • Visual Acuity [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Is there a change in visual acuity and contrast sensitivity with reading as a stressor in patients with dry eye comparing to controls?

  • 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


Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Dry Eye
Patients with Sjogren Syndrome related or non-Sjogren Syndrome related dry eye.
Other: 30 minutes sustained reading
Controls
Patients without dry eye.
Other: 30 minutes sustained reading

  Eligibility

Ages Eligible for Study:   50 Years and older
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 eyedrops (including, cyclosporine and steroids as well as any glaucoma eyedrops).
  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

Contacts
Contact: Esen K Akpek, MD 410 955-5214 esakpek@jhmi.edu

Locations
United States, Maryland
The Wilmer Eye Institute, Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Allergan
  More Information

No publications provided

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
Last Updated: April 8, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014