Validation of Computerized Vision-Targeted Quality-of-Life Questionnaires - Full Text View

Sponsored by:	National Eye Institute (NEI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00678860

Purpose

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.)

Condition
Eye Disease

MedlinePlus related topics: Eye Diseases

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Pilot Validation Study of Computer Administration of Vision Targeted Quality of Life Instruments

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	120
Study Start Date:	May 2008

Detailed Description:

The purpose of this protocol is to compare the health-related quality of life (visual function) reported by participants when using web-based questionnaires versus their responses obtained when using standard paper versions of the questionnaires. This comparison will be performed in a population of patients diagnosed with ocular surface disease (OSD) and in age- and gender-matched controls by using a randomized, cross-over study design. This type of comparative study of patient-reported outcomes has been reported for rheumatology, cardiology, psychiatry, asthma, alcoholism, pain assessment, gastrointestinal disease, diabetes, and allergy populations; however, to our knowledge there have been no reports of such a study from patients with ocular disease. The study will evaluate the agreement between scores reported via two modes of administration: a web-based version and a paper-and-pencil version. Components of three questionnaires commonly used to evaluate visual function, symptoms, and vision-related quality of life in OSD will be included: the initial 5 questions of the Ocular Surface Index (OSDI), question #15 of the National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25), and specified domains of the National Eye Institute Refractive Error Quality Of Life Instrument-42 (RQL-42) (clarity of vision, near vision, far vision, glare, symptoms, worry, and satisfaction with correction).

The study will also evaluate whether there are differences in mean overall score by age, gender, order of administration, or disease severity.

Ocular surface disease, which includes dry eye disease secondary to a variety of etiologies, is an ophthalmic condition which places a burden not just on functional vision, but also on overall health related quality of life (HRQoL), with an impact similar to that of moderate angina3. This study will add to the body of knowledge in the field of patient-reported outcome measures (PROs), and will be the first to compare the computerized, web-based and paper-based versions of previously validated questionnaires used to assess QoL in subjects with ocular disease.

There has been an increasing interest in assessing PROs in many fields of medicine, especially in the context of clinical trials where HRQoL is an important component of the overall evaluation of an intervention or treatment. As the use of computers increases and accessibility to the internet broadens, there is a tremendous potential in harnessing this technology in the future as a cost-effective, efficient way to gather clinical data on PROs for future ophthalmic clinical trials and studies.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 18 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.
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.

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.
Uncontrolled systemic disease.
Active ocular disease other then ocular surface disease 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 ).

INCLUSION CRITERIA FOR CONTROL GROUP:

Age greater than or equal to 18 years.
Schirmer I test greater than 10 mm wetting over 5 minutes and tear breakup time greater than 10 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.

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.
Uncontrolled systemic disease.
Active ocular 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678860

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Eye Institute (NEI)

More Information

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

[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.

Miljanović 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.

Study ID Numbers:	080135, 08-EI-0135
Study First Received:	May 14, 2008
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00678860
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Questionnaire
Computer Assisted Interface
Quality of Life
Dry Eye
Ocular Surface Disease

Dry Eye
Quality of Life
Healthy Volunteer
HV

Study placed in the following topic categories:

Eye Diseases
Quality of Life
Healthy

ClinicalTrials.gov processed this record on January 15, 2009