Status:
COMPLETED
Validation of Computerized Vision-Targeted Quality-of-Life Questionnaires
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Eye Disease
Eligibility:
All Genders
18+ years
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 qualit...
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 ...
Eligibility Criteria
Inclusion
- 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 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.
- 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 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).
- INCLUSION CRITERIA FOR CONTROL GROUP:
- 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
- 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
Exclusion
Key Trial Info
Start Date :
May 9 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2011
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00678860
Start Date
May 9 2008
End Date
October 31 2011
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892