How Has Glaucoma Affected Your Quality of Life?

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Factors Influencing Patient Satisfaction in a Glaucoma Population

NCT02628327

Glaucoma

COMPLETED

Does Glaucoma Cause Loss of Brain Function?

NCT01303939

Glaucoma

COMPLETED NA

Impact of Meditation on Improving Quality of Life Among Glaucoma Patients: An Electronic Pilot Feasibility Study

NCT05697094

Glaucoma Depression Anxiety +2 more

NOT_YET_RECRUITING NA

Impact of Glaucoma and Visual Field Loss on Life Space

NCT03673644

Primary Open-angle Glaucoma

ACTIVE_NOT_RECRUITING

Interest in Electronic Applications for Patients With Glaucoma

NCT02659709

Glaucoma

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type OTHER

Clinical evaluation

Intervention Type OTHER

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

Performance based measures

Intervention Type OTHER

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

Subjective measures of vision-related quality of life

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clinical evaluation

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

Intervention Type OTHER

Performance based measures

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

Intervention Type OTHER

Subjective measures of vision-related quality of life

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ophthalmic examination Compressed Assessment of Ability Related to Vision Visual Functioning Questionnaire; Modified Glaucoma Symptom Scale

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No