How Has Glaucoma Affected Your Quality of Life?

Wills Eye

Status: Completed

Conditions: Quality of Life; Glaucoma

Treatments: Other: Clinical evaluation; Other: Performance based measures; Other: Subjective measures of vision-related quality of life

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01476644

IRB#11-128

Details and patient eligibility

About

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.

Full 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.

Enrollment: 161 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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161 participants in 1 patient group

Glaucoma Patients

Other group

Description:

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).

Treatment:

Other: Subjective measures of vision-related quality of life

Other: Performance based measures

Other: Clinical evaluation