Clinical trial NCT01476644: How Has Glaucoma Affected Your Quality of Life?
Official title: A Prospective, Longitudinal, Observational Cohort Study Examining How Glaucoma Affects Quality of Life and Visual Function Over a 4-Year Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Quality of Life
Keywords: Health related quality of life
Clinical measures of vision
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-11-22
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, longitudinal,observational cohort study to investigate how glaucoma affects patients' quality of life and visually-related function. Annual visits 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 measure: the Compressed Assessment of Ability Related to Vision; and (3) Subjective measures of vision-related quality of life (the National Eye Institute Visual Functioning Questionnaire 25 and the Modified Glaucoma Symptom Scale).
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life With NEI VFQ-25
timeFrame: 2 hours at each annual visit, visits 2 through 5
Secondary outcomes:
measure: Eye Comfort With MGSS
timeFrame: 2 hours at each annual visit, visits 2 through 5
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Institute
state: Pennsylvania
Study officials:
affiliation: Glaucoma Service, Wills Eye Institute
name: George L Spaeth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.