Protocol Number: 08-EI-0135

Title:

Pilot Validation Study of Computer Administration of Vision Targeted Quality of Life Instruments

Number:

08-EI-0135

Summary:

This study will test and compare computerized and paper versions of eye questionnaires. Questionnaires are used in medicine to gain a better understanding of how a disease can impact a person's quality of life. Computerized versions of such questionnaires are often as good as or better than paper versions, but there has been no direct comparison of the two. This study may help in the development of eye questionnaires used to understand symptoms and monitor patients in clinical trials.

People 21 years of age and older with ocular surface disease (OSD) and matched control subjects without OSD may be eligible for this study. All participants undergo the following procedures:

-Medical and eye history.

-Vision test and examination of the front part of the eye.

-Tear measurement: A small piece of paper is placed on the surface of the eye to measure the amount of tears produced. The consistency of the tears is measured by looking at how fast they evaporate from the surface of the eye.

-Completion of either paper-based or computer-based version of a questionnaire 15 minutes after the eye examination and completion of the other version within 1 week at home. (Subjects who complete the paper version in the clinic are told how to access the computer version online at home or on a library computer; those who complete the computer version in the clinic are given a paper version to take home.)

Sponsoring Institute:

National Eye Institute (NEI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

The study cohort will be comprised of eighty (80) participants diagnosed with OSD and 40 controls without OSD comprised of similar numbers of men and women.

INCLUSION CRITERIA FOR OSD GROUP:

-Patients greater than or equal to 21 years of age with a diagnosis of ocular surface disease confirmed by investigator.

-Schirmer I less than or equal to 10 mm wetting over 5 minutes or tear breakup time less than or equal to 10 seconds.

-Best corrected binocular visual acuity at intermediate and near equal to or greater than 20/40 (Jaeger 3).

-Literacy and fluency in English sufficient to follow study instructions and likely to be able to comprehend the questionnaires.

-Ability and willingness to complete the study protocol.

EXCLUSION CRITERIA FOR OSD GROUP:

-Ocular surgery or infection within 3 months of study enrollment.

-Inability to obtain appropriate consent.

-Allergy or sensitivity to any medication used in study.

-Subject has a situation or condition, which in the investigator's opinion, may put the subject at a significant risk, may confound the study result, or may interfere significantly with the participation in the study.

-Systemic anxiolytics or antidepressants.

-Uncontrolled systemic disease.

-Active ocular disease other then ocular surface disease.

-Any disability preventing timely, efficient completion of writing or keyboarding tasks.

-Incapable of providing informed consent.

-Monocular vision (legal blindness in one eye ).

INCLUSION CRITERIA FOR CONTROL GROUP:

-Age greater than 21 years.

-Schirmer I test greater than 10 mm wetting over 5 minutes and tear breakup time greater than 10 seconds.

-Best corrected binocular visual acuity at intermediate and near equal to or greater than 20/40 (Jaeger 3).

-Literacy and fluency in English sufficient to follow study instructions and likely to be able to comprehend the questionnaire.

-Ability and willingness to complete the study protocol.

EXCLUSION CRITERIA FOR CONTROL GROUP:

-A diagnosis of ocular surface disease made by a clinician.

-Ocular surgery or infection within 6 months of study enrollment.

-Pupillary, motility, convergence or accommodative ocular disorder judged by investigator to have potential to negatively impact ease of near and intermediate binocular visual function

-Inability to obtain appropriate consent.

-Allergy or sensitivity to any medication used in study.

-Monocular vision (legal blindness in one eye) or subject has a situation or condition, which in the investigator's opinion, may put the subject at a significant risk, may confound the study results, or may interfere significantly with the participation in the study.

-Systemic anxiolytics or antidepressants.

-Uncontrolled systemic disease.

-Active ocular disease other then ocular surface disease.

-Any disability preventing timely, efficient completion of writing or keyboarding tasks.

-Incapable of providing informed consent

Special Instructions:

Currently Not Provided

Keywords:

Questionnaire

Computer Assisted Interface

Quality of Life

Dry Eye

Recruitment Keyword(s):

Ocular Surface Disease

Dry Eye

Quality of Life

Healthy Volunteer

HV

Condition(s):

Eye Disease

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Eye Institute

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

[No authors listed] Study protocol for the World Health Organization project to develop a Quality of Life assessment instrument (WHOQOL). Qual Life Res. 1993 Apr;2(2):153-9.

Miljanovi? B, Dana R, Sullivan DA, Schaumberg DA. Impact of dry eye syndrome on vision-related quality of life. Am J Ophthalmol. 2007 Mar;143(3):409-15. Epub 2007 Jan 2.

Schiffman RM, Walt JG, Jacobsen G, Doyle JJ, Lebovics G, Sumner W. Utility assessment among patients with dry eye disease. Ophthalmology. 2003 Jul;110(7):1412-9.

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