Development of the Glaucoma Visual Functioning Questionnaire-40 and Its Psychometric Properties

Zhongshan Ophthalmic Center, Sun Yat-sen University400 enrolled

Overview

The objective of this study is to develop and test the psychometric properties of a self-report questionaire, the Glaucoma Visual Functioning Questionnaire-40 (GVFQ-40), which was designed to measure the difficulty of daily activities of glaucoma patients and evaluate the effectiveness of clinical treatment or rehabilitation interventions.

Glaucoma is the leading cause of irreversible blindness in the world. It is estimated that by 2040, the number of glaucoma patients in the world's population aged 40-80 will exceed 110 million \[1\]. As a chronic progressive blindness disease, glaucoma can seriously damage visual function such as visual acuity, visual field and contrast sensitivity, restrict patients' daily life activities and leads to a serious decline in vision-related quality of life (VRQOL) and health-related quality of life (HRQOL) \[2-5\]. Comprehensive evaluation of the visual function of glaucoma patients can not only educate the impact of glaucoma, but also reflect the effect of clinical treatment or rehabilitation interventions. However, the objective testing methods commonly used in clinic, such as visual acuity, visual field and contrast sensitivity, can only be used to evaluate part of the visual function of patients, which can not reflect the impact of disease and corresponding interventions from the point of view of patients. The use of patient defined measures of vision function in ophthalmic assessment and treatment evaluation is now well accepted and a number of questionnaires have been developed, such as NEI VFQ-25, LVQOL and SF-36, which mostly focus on investigating VRQOL or HRQOL\[6-10\]. There are comparatively few vision function questionnaires developed to measure the visual ability for glaucoma patients. The objective of this study is to develop and test the psychometric properties of a self-report questionaire, the Glaucoma Visual Functioning Questionnaire-40 (GVFQ-40), which was designed to measure the difficulty of daily activities of glaucoma patients and evaluate the effectiveness of clinical treatment or rehabilitation interventions. The GVFQ-40 consists of 40 items and measures the impact of glaucoma on restriction of participation in daily activities in five domains of functioning (mobility, visual tracking, reading, identification and night vision ). Each item has six answer options, that is, no difficulty (score = 1), mild difficulty (score = 2), moderate difficulty (score = 3), extremely difficult (score = 4), completely unable to complete (score = 5), and do not performed for nonvisual reasons (no score).

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Primary Glaucoma Glaucoma Suspect

Interventions

GVFQ-40OTHER

GVFQ-40 is a 40-item questionnaire developed to evaluate the visual ability of glaucoma patients in detail. It consists of 40 items and measures the impact of glaucoma on restriction of participation in daily activities in five domains of functioning. Each item is rated on a five-level scale from ''no difficulty'' to ''can't do because of vision''. Another possible response is that the activity is not performed for nonvisual reasons.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1.1 Inclusion criteria of primary glaucoma group: 1. age ≥ 18 years old; 2. being able to express clearly and cooperate with the investigators; 3. diagnosed with primary glaucoma; 4. complete clinical data. 1.2 Inclusion criteria of glaucoma suspect controls: 1. age ≥ 18 years old; 2. being able to express clearly and cooperate with the investigators; 3. diagnosed with glaucoma suspect or ocular hypertension; 4. having a presenting Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity of 20/40 or better in both eyes; 5. complete clinical data. Exclusion Criteria: 1.1 Exclusion criteria for primary glaucoma group: 1. serious cognitive dysfunction, psychological dysfunction, or hearing impairment; 2. physical motor dysfunction, hyperthyroidism or hypothyroidism, malignant tumors and other serious systemic diseases; 3. complicated with other ophthalmopathy affecting visual function (except cataract, ametropia), such as age-related macular degeneration, diabetic retinopathy, optic nerve disease, retinal vascular disease, etc; 4. surgical intervention (incisional or laser) within 2 weeks of the date of completing questionnaires (before or after); 5. not complete the questionnaire. 1.2 Exclusion criteria for glaucoma suspect controls: 1. serious cognitive dysfunction, psychological dysfunction, or hearing impairment; 2. physical motor dysfunction, hyperthyroidism or hypothyroidism, malignant tumors and other serious systemic diseases; 3. complicated with other ophthalmopathy affecting visual function (except cataract, ametropia), such as age-related macular degeneration, diabetic retinopathy, optic nerve disease, retinal vascular disease, etc; 4. not complete the questionnaire.

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

GVFQ-40

Time frame: 1 day (Only once)

Secondary Outcomes

Diagnosis and treatment information of ophthalmopathy

The diagnosis and treatment information of ophthalmopathy, such as disease diagnosis name, time, history of drug treatment and history of operation, were obtained from the hospital electronic medical record system or outpatient medical record data.

Time frame: 1 day (Only once)

NEI VFQ-25

The National Eye Institute-Visual Function Questionnaire-25 (NEI VFQ-25) is a valid and reliable VRQOL questionnaire designed for persons who have chronic eye diseases or low vision.

Time frame: 1 day (Only once)

ETDRS visual acuity

The information of ETDRS visual acuity was obtained from the hospital electronic medical record system or outpatient medical record data.

Time frame: 1 day (Only once)

Intraocular pressure

The information of intraocular pressure was obtained from the hospital electronic medical record system or outpatient medical record data.

Time frame: 1 day (Only once)

Automatic perimetry report

Data from ClinicalTrials.gov

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