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

22 januari 2021 uppdaterad 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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).

Studietyp

Observationell

Inskrivning (Förväntat)

400

Kontakter och platser

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Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

  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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Primary Glaucoma
Patients with primary glaucoma diagnosed by glaucoma professionals
Övrig: 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.
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
GVFQ-40
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Diagnosis and treatment information of ophthalmopathy
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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 kontrastkänslighet
Tidsram: 1 dag (endast en gång)
Pelli-Robson testkort för kontrastkänslighet användes.
1 dag (endast en gång)

Samarbetspartners och utredare

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Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Publikationer och användbara länkar

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Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

8 september 2020

Primärt slutförande (Förväntat)

30 april 2021

Avslutad studie (Förväntat)

30 maj 2021

Studieregistreringsdatum

Först inskickad

21 januari 2021

Först inskickad som uppfyllde QC-kriterierna

22 januari 2021

Första postat (Faktisk)

25 januari 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 januari 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 januari 2021

Senast verifierad

1 januari 2021

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2020KYPJ186

Plan för individuella deltagardata (IPD)

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NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

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Nej

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