Eye DiseaseNCT00678860
Validation of Computerized Vision-Targeted Quality-of-Life Questionnaires
An observational study of Eye Disease, run by National Eye Institute (NEI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Disease
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2008to 31 Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- Any disability preventing timely, efficient completion of writing or keyboarding tasks.
- Incapable of providing informed consent.
- Monocular vision (legal blindness in one eye).
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Pilot Validation Study of Computer Administration of Vision Targeted Quality of Life Instruments
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.)
Read the 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.
- Conditions
- Eye Disease
- Keywords
- Questionnaire, Computer Assisted Interface, Quality of Life, Dry Eye, Ocular Surface Disease, Healthy Volunteer, HV
- Medical subject headings
- Eye Diseases, Dry Eye Syndromes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study start9 May 2008
- Study completion31 Oct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678860
- Sponsor's protocol ID
- 080135
- Other IDs
- 08-EI-0135
- Status last verified
- 31 Oct 2011
- First submitted
- 14 May 2008
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 8518769Miljanovic 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.
PubMed 17317388Schiffman 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.
PubMed 12867401
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Validation Study of Computer Administration of Vision Targeted Quality of Life Instruments
- ClinicalTrials.gov ID
- NCT00678860
- Acronym / sponsor ID
- 080135
- Conditions
- Eye Disease
- Keywords
- Questionnaire, Computer Assisted Interface, Quality of Life, Dry Eye, Ocular Surface Disease, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 9 May 2008
- Study completion
- 31 Oct 2011
- First posted
- 16 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 8518769Study 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.
- Background: PubMed 17317388Miljanovic 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.
- Background: PubMed 12867401Schiffman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Disease, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00678860, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.