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

22. januar 2021 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Observasjonsmessig

Registrering (Forventet)

400

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

  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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Primary Glaucoma
Patients with primary glaucoma diagnosed by glaucoma professionals
Annen: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
GVFQ-40
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Diagnosis and treatment information of ophthalmopathy
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Pelli-Robson kontrastfølsomhet
Tidsramme: 1 dag (kun én gang)
Pelli-Robson testkort for kontrastfølsomhet ble brukt.
1 dag (kun én gang)

Samarbeidspartnere og etterforskere

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Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

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Studer hoveddatoer

Studiestart (Faktiske)

8. september 2020

Primær fullføring (Forventet)

30. april 2021

Studiet fullført (Forventet)

30. mai 2021

Datoer for studieregistrering

Først innsendt

21. januar 2021

Først innsendt som oppfylte QC-kriteriene

22. januar 2021

Først lagt ut (Faktiske)

25. januar 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. januar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. januar 2021

Sist bekreftet

1. januar 2021

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2020KYPJ186

Plan for individuelle deltakerdata (IPD)

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Nei

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Nei

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