Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04722861
Enrollment
400
Registered
2021-01-25
Start date
2020-09-08
Completion date
2021-05-30
Last updated
2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma Suspect, Primary Glaucoma

Brief summary

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.

Detailed description

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).

Interventions

OTHERGVFQ-40

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.

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
GVFQ-401 day (Only once)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. The GVFQ-40 is administered by a trained interviewer to all enrolled participants. A subset of participants (35 subjects) will complete the GVFQ-40 twice 2 to 3 weeks apart.

Secondary

MeasureTime frameDescription
NEI VFQ-251 day (Only once)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.
ETDRS visual acuity1 day (Only once)The information of ETDRS visual acuity was obtained from the hospital electronic medical record system or outpatient medical record data.
Diagnosis and treatment information of ophthalmopathy1 day (Only once)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.
Automatic perimetry report1 day (Only once)Automatic perimetry reports were obtained from the hospital electronic medical record system or outpatient medical record data.
Pelli-Robson contrast sensitivity1 day (Only once)Pelli-Robson contrast sensitivity test card was used.
Intraocular pressure1 day (Only once)The information of intraocular pressure was obtained from the hospital electronic medical record system or outpatient medical record data.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026