Clinical trial NCT04722861: Development of the Glaucoma Visual Functioning Questionnaire-40 and Its Psychometric Properties
Official title: Development of the Glaucoma Visual Functioning Questionnaire-40 and Its Psychometric Properties
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Glaucoma
Glaucoma Suspect
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Primary glaucoma: patients with primary glaucoma diagnosed by glaucoma professionals
2. Glaucoma Suspect Controls: glaucoma suspect controls had a diagnosis of glaucoma suspect or ocular hypertension, and also were required to have a presenting Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity of 20/40 or better in both eyes.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: GVFQ-40
timeFrame: 1 day (Only once)
Secondary outcomes:
measure: Diagnosis and treatment information of ophthalmopathy
timeFrame: 1 day (Only once)
measure: NEI VFQ-25
timeFrame: 1 day (Only once)
measure: ETDRS visual acuity
timeFrame: 1 day (Only once)
measure: Intraocular pressure
timeFrame: 1 day (Only once)
measure: Automatic perimetry report
timeFrame: 1 day (Only once)
measure: Pelli-Robson contrast sensitivity
timeFrame: 1 day (Only once)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
citation: Jones L, Garway-Heath DF, Azuara-Blanco A, Crabb DP; United Kingdom Glaucoma Treatment Study Investigators. Are Patient Self-Reported Outcome Measures Sensitive Enough to Be Used as End Points in Clinical Trials?: Evidence from the United Kingdom Glaucoma Treatment Study. Ophthalmology. 2019 May;126(5):682-689. doi: 10.1016/j.ophtha.2018.09.034. Epub 2018 Sep 28.
citation: Sivaprasad S, Tschosik E, Kapre A, Varma R, Bressler NM, Kimel M, Dolan C, Silverman D. Reliability and Construct Validity of the NEI VFQ-25 in a Subset of Patients With Geographic Atrophy From the Phase 2 Mahalo Study. Am J Ophthalmol. 2018 Jun;190:1-8. doi: 10.1016/j.ajo.2018.03.006. Epub 2018 Mar 10.
citation: Huang H, Lin J, Luo M, Li Z, Zhu Y, Han J, Jin L, Li Y, Zhuo Y. Development and validation of the 40-item Glaucoma Visual Functioning Questionnaire. Br J Ophthalmol. 2023 Aug;107(8):1086-1091. doi: 10.1136/bjophthalmol-2021-320985. Epub 2022 Apr 4.