How Has Glaucoma Affected Your Quality of Life?
1 november 2019 bijgewerkt door: George L. Spaeth MD, Wills Eye
A Prospective, Longitudinal, Observational Cohort Study Examining How Glaucoma Affects Quality of Life and Visual Function Over a 4-Year Period
Hypothesis 1: Self-reported health-related quality of life decreases as vision impairment worsens in subjects with glaucoma.
Hypothesis 2: Changes in health-related quality of life are associated with changes in clinical measures of vision and performance-based measures of visual function.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
You are being asked to participate in this research study because you have glaucoma, which is the second leading cause of blindness in the world and accounts for 15% of blindness worldwide. Vision loss caused by glaucoma can significantly worsen your health-related quality of life. Despite the fact that glaucoma has such a big impact on a large number of people, research examining the long-term effects of glaucoma-related vision loss on one's quality of life is scarce.
The purpose of this study is to look at the long-term effect of this condition on your quality of life so that we may gain valuable information about what factors influence the quality of life of people with glaucoma. To participate in this study, you will need to allow us to perform clinical tests on your eyes, to self-report your well-being and health-related quality of life, and to let us know how well you perform your daily life activities.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
161
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19107
- Wills Eye Institute
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 80 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Minimum 2-year diagnosis of primary open-angle glaucoma, chronic primary angle-closure glaucoma or exfoliation glaucoma
- Disk Damage Likelihood Scale stages 5 through 8 with visual field loss
- Age between 21 and 80 years
- Able to understand and speak English
Exclusion Criteria:
- Unlikely to be available for annual ocular examination and reassessment across a 4-year period
- Neurological or musculoskeletal problems that would influence performance on activities of daily living
- Cognitively impaired, as assessed by a face-to-face Mini-Mental State Examination
- Incisional eye surgery within the past three months
- Laser therapy within the previous month
- Any cause for visual reduction other than glaucoma
- Any medical condition which in the investigator's opinion would preclude the subject from providing reliable and valid data
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Ander: Glaucoma Patients
Moderate glaucoma patients with a minimum 2-year diagnosis of primary open-angle glaucoma, chronic primary angle-closure glaucoma or pseudoexfoliation glaucoma were included to complete annual visits over a 4 year period.
Each visit included (1) Clinical evaluation: a slit lamp examination, fundoscopy, intraocular pressure measurement, visual field examination, spectral domain optical coherence tomography, Pelli-Robson Contrast Sensitivity test and the Spaeth-Richman Contrast Sensitivity test; (2) a performance based measures: the Compressed Assessment of Ability Related to Vision; and (3) Subjective measures of vision-related quality of life (VRQoL) (the National Eye Institute Visual Functioning Questionnaire 25 and the Modified Glaucoma Symptom Scale).
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Biomicroscopy (look at front of eye), ophthalmoscopy (look at back of eye), visual acuity, visual fields, intraocular pressure, spectral domain optical coherence tomography, Pelli-Robson and the Spaeth-Richman Contrast Sensitivity tests
Andere namen:
Compressed Assessment of Ability Related to Vision (CAARV) items include: 1) computerized motion detection; 2) recognizing facial expressions; 3) reading street signs; and 4) finding objects in a room
Andere namen:
National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ-25) includes a series of questions pertaining to vision or feelings about a vision condition and the Modified Glaucoma Symptom Scale (MGSS) includes a series of questions pertaining to eye comfort.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Quality of Life With NEI VFQ-25
Tijdsspanne: 2 hours at each annual visit, visits 2 through 5
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National Eye Institute Visual Function-25 questionnaire (NEI VFQ-25) is a measurement of patients perception of their visually related quality of life.
Patients select answers from multiple choice lists of responses.
Values are re-coded and converted to a scale of 0 to 100 where 0 is extreme difficulty and 100 is no difficulty at all (or best quality of life).
Data from visits 2 through 5.
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2 hours at each annual visit, visits 2 through 5
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Eye Comfort With MGSS
Tijdsspanne: 2 hours at each annual visit, visits 2 through 5
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Modified Glaucoma Symptom Scale (MGSS), is patient perception of their eyes comfort.
Ten ocular complaints often associated with glaucoma each have a four level score (1 signifying very bothersome; 4 represents absence of problems).
Scores from 10 questions are added and range from 0 to 100 where 0 represents significant discomfort and 100 represents no problems at all.
The final MGSS score is an unweighted average of responses to 10 items, averaged between the 2 eyes.
Data from visits 2 through 5.
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2 hours at each annual visit, visits 2 through 5
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: George L Spaeth, MD, Glaucoma Service, Wills Eye Institute
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Sun Y, Erdem E, Wizov S, Kayak N, Wei H, Spaeth GL. Quality of life measures in moderate glaucoma: study design and methodology. Abstract submitted, Association for Research in Vision and Ophthalmology, Dec 2012.
- Ekici F, Sun Y, Taranum S, Martinez P, Erdem E, Nayak N, Wizov SS, Waisbourd M, Spaeth GL. Relationship between baseline clinical characteristics and vision-related quality of life in patients with glaucoma. ARVO Poster 176-A0363 May 2014.
- Gogte P., Hark LA., Spaeth E., Richman J., Wizov SS., Waisbourd M., Spaeth GL. Contrast Sensitivity - A Meaningful Way to Assess Health Related Quality of Life and Ability to Perform Daily Activities in Glaucoma Patients. ARVO Poster 2097-A0004 May 2015.
- Waisbourd M., Gogte P., Richman J., Spaeth E., Dai Y., Wizov SS., Hark LA., Spaeth GL. Comparative Results with Regards to Humphrey Visual Fields and the SPARCS Contrast Sensitivity Test in Patients with Glaucoma. AOS meeting April 2015.
- Waisbourd M, Parker S, Ekici F, Martinez P, Murphy R, Scully K, Wizov SS, Hark LA, Spaeth GL. A prospective, longitudinal, observational cohort study examining how glaucoma affects quality of life and visually-related function over 4 years: design and methodology. BMC Ophthalmol. 2015 Aug 1;15:91. doi: 10.1186/s12886-015-0088-x.
- Ekici F, Loh R, Waisbourd M, Sun Y, Martinez P, Nayak N, Wizov SS, Hegarty S, Hark LA, Spaeth GL. Relationships Between Measures of the Ability to Perform Vision-Related Activities, Vision-Related Quality of Life, and Clinical Findings in Patients With Glaucoma. JAMA Ophthalmol. 2015 Dec;133(12):1377-85. doi: 10.1001/jamaophthalmol.2015.3426.
- Sun Y, Lin C, Waisbourd M, Ekici F, Erdem E, Wizov SS, Hark LA, Spaeth GL. The Impact of Visual Field Clusters on Performance-based Measures and Vision-Related Quality of Life in Patients With Glaucoma. Am J Ophthalmol. 2016 Mar;163:45-52. doi: 10.1016/j.ajo.2015.12.006. Epub 2015 Dec 14.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 oktober 2011
Primaire voltooiing (Werkelijk)
1 juli 2016
Studie voltooiing (Werkelijk)
1 juni 2017
Studieregistratiedata
Eerst ingediend
31 oktober 2011
Eerst ingediend dat voldeed aan de QC-criteria
21 november 2011
Eerst geplaatst (Schatting)
22 november 2011
Updates van studierecords
Laatste update geplaatst (Werkelijk)
15 november 2019
Laatste update ingediend die voldeed aan QC-criteria
1 november 2019
Laatst geverifieerd
1 november 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB#11-128
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .