How Has Glaucoma Affected Your Quality of Life?

Study Overview
=================
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.

Official Title
-----------------
A Prospective, Longitudinal, Observational Cohort Study Examining How Glaucoma Affects Quality of Life and Visual Function Over a 4-Year Period

Conditions
-----------------
Glaucoma, Quality of Life

Intervention / Treatment
-----------------
* Other: Clinical evaluation
* Other: Performance based measures
* Other: Subjective measures of vision-related quality of life


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Glaucoma Patients<br>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). | Other: Clinical evaluation<br>* 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<br>* Other names: Ophthalmic examination;Other: Performance based measures<br>* 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<br>* Other names: Compressed Assessment of Ability Related to Vision;Other: Subjective measures of vision-related quality of life<br>* 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.<br>* Other names: Visual Functioning Questionnaire; Modified Glaucoma Symptom Scale;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life With NEI VFQ-25 | 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. | 2 hours at each annual visit, visits 2 through 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye Comfort With MGSS | 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. | 2 hours at each annual visit, visits 2 through 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health related quality of life, Clinical measures of vision