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

22 de enero de 2021 actualizado por: Zhongshan Ophthalmic Center, Sun Yat-sen University
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.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

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).

Tipo de estudio

De observación

Inscripción (Anticipado)

400

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Porcelana
    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510060
        • Zhongshan Ophthalmic Center, Sun Yat-sen University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

  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.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Primary Glaucoma
Patients with primary glaucoma diagnosed by glaucoma professionals
Otro: GVFQ-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.
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.
Otro: GVFQ-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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
GVFQ-40
Periodo de tiempo: 1 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.
1 day (Only once)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Diagnosis and treatment information of ophthalmopathy
Periodo de tiempo: 1 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.
1 day (Only once)
NEI VFQ-25
Periodo de tiempo: 1 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.
1 day (Only once)
ETDRS visual acuity
Periodo de tiempo: 1 day (Only once)
The information of ETDRS visual acuity was obtained from the hospital electronic medical record system or outpatient medical record data.
1 day (Only once)
Intraocular pressure
Periodo de tiempo: 1 day (Only once)
The information of intraocular pressure was obtained from the hospital electronic medical record system or outpatient medical record data.
1 day (Only once)
Automatic perimetry report
Periodo de tiempo: 1 day (Only once)
Automatic perimetry reports were obtained from the hospital electronic medical record system or outpatient medical record data.
1 day (Only once)
Sensibilidad al contraste Pelli-Robson
Periodo de tiempo: 1 día (Solo una vez)
Se utilizó la tarjeta de prueba de sensibilidad al contraste Pelli-Robson.
1 día (Solo una vez)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Zhongshan Ophthalmic Center, Sun Yat-sen University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

8 de septiembre de 2020

Finalización primaria (Anticipado)

30 de abril de 2021

Finalización del estudio (Anticipado)

30 de mayo de 2021

Fechas de registro del estudio

Enviado por primera vez

21 de enero de 2021

Primero enviado que cumplió con los criterios de control de calidad

22 de enero de 2021

Publicado por primera vez (Actual)

25 de enero de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de enero de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

22 de enero de 2021

Última verificación

1 de enero de 2021

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2020KYPJ186

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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