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OpenTrials
Completed

NCT Number: NCT01826812

Impairment of Reading Ability in Dry Eye Patients

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

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Wilmer Eye Institute, Johns Hopkins University

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

30 minutes sustained reading

Other

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

Dry eye exam

Other

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

Primary outcomes

  1. Sustained Silent Reading Speed

    Time frame: 30 minutes

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Allergan

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 9, 2013
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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