- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04722861
Development of the Glaucoma Visual Functioning Questionnaire-40 and Its Psychometric Properties
Přehled studie
Detailní popis
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).
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
-
-
Guangdong
-
Guangzhou, Guangdong, Čína, 510060
- Zhongshan Ophthalmic Center, Sun Yat-sen University
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
- Primary glaucoma: patients with primary glaucoma diagnosed by glaucoma professionals
- 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.
Popis
Inclusion Criteria:
1.1 Inclusion criteria of primary glaucoma group:
- age ≥ 18 years old;
- being able to express clearly and cooperate with the investigators;
- diagnosed with primary glaucoma;
- complete clinical data.
1.2 Inclusion criteria of glaucoma suspect controls:
- age ≥ 18 years old;
- being able to express clearly and cooperate with the investigators;
- diagnosed with glaucoma suspect or ocular hypertension;
- having a presenting Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity of 20/40 or better in both eyes;
- complete clinical data.
Exclusion Criteria:
1.1 Exclusion criteria for primary glaucoma group:
- serious cognitive dysfunction, psychological dysfunction, or hearing impairment;
- physical motor dysfunction, hyperthyroidism or hypothyroidism, malignant tumors and other serious systemic diseases;
- 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;
- surgical intervention (incisional or laser) within 2 weeks of the date of completing questionnaires (before or after);
- not complete the questionnaire.
1.2 Exclusion criteria for glaucoma suspect controls:
- serious cognitive dysfunction, psychological dysfunction, or hearing impairment;
- physical motor dysfunction, hyperthyroidism or hypothyroidism, malignant tumors and other serious systemic diseases;
- 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;
- not complete the questionnaire.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
Primary Glaucoma
Patients with primary glaucoma diagnosed by glaucoma professionals
|
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.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
GVFQ-40
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Diagnosis and treatment information of ophthalmopathy
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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 contrast sensitivity
Časové okno: 1 day (Only once)
|
Pelli-Robson contrast sensitivity test card was used.
|
1 day (Only once)
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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. 2022 Apr 4:bjophthalmol-2021-320985. doi: 10.1136/bjophthalmol-2021-320985. Online ahead of print.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2020KYPJ186
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na GVFQ-40
-
Region Örebro CountyNáborMechanická ventilace | Atelektáza | Distribuce ventilaceŠvédsko
-
Yonsei UniversityNeznámý
-
Breas Medical S.A.R.L.StaženoSyndrom hypoventilace obezityFrancie
-
Daewoong Pharmaceutical Co. LTD.DokončenoErozivní ezofagitidaKorejská republika
-
Universidade Federal do Rio de JaneiroDokončenoÚprava stravyBrazílie
-
Hanlim Pharm. Co., Ltd.DokončenoZdravé mužské subjektyKorejská republika
-
University of ZurichDokončeno
-
South China Center For Innovative PharmaceuticalsXiangya Hospital of Central South UniversityDokončeno
-
Johns Hopkins UniversityNational Institute on Aging (NIA)Aktivní, ne nábor
-
Grupo Español de Tumores Huérfanos e InfrecuentesAstellas Pharma Inc; Apices Soluciones S.L.Dokončeno