Validation of Computerized Vision-Targeted Quality-of-Life Questionnaires

NCT00678860 | Completed

• 2 other identifiers: 08013508-EI-0135
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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.)

Conditions

Eye Disease

Keywords

Questionnaire; Computer Assisted Interface; Quality of Life; Dry Eye; Ocular Surface Disease; Healthy Volunteer; HV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients greater than or equal to 18 years of age with a diagnosis of ocular surface disease confirmed by investigator.
• Schirmer I less than 10 mm wetting over 5 minutes OR tear breakup time less than or equal to 5 seconds.
• Binocular visual acuity at near equal to or greater than 20/40 (Jaeger 3) with habitual correction.
• 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.

You may not qualify if:

• 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.
• Uncontrolled systemic disease.
• Active ocular disease other than ocular surface disease 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.
• Any disability preventing timely, efficient completion of writing or keyboarding tasks.
• Incapable of providing informed consent.
• Monocular vision (legal blindness in one eye).
• Age greater than or equal to 18 years.
• Schirmer I test greater than or equal to 10 mm wetting over 5 minutes OR tear breakup time greater than 5 seconds.
• Binocular visual acuity at near equal to or greater than 20/40 (Jaeger 3) with habitual correction
• 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
• A diagnosis of ocular surface disease made by a clinician

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 8518769 BACKGROUND

• Miljanovic 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. doi: 10.1016/j.ajo.2006.11.060. Epub 2007 Jan 2.

  PMID: 17317388 BACKGROUND

• 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. doi: 10.1016/S0161-6420(03)00462-7.

  PMID: 12867401 BACKGROUND

MeSH Terms

Conditions

Eye Diseases; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 16, 2008
• Study Start: May 9, 2008
• Study Completion: October 31, 2011
• Last Updated: July 2, 2017

Record last verified: 2011-10-31

Locations

US (1)