Viewing Study NCT04722861



Ignite Creation Date: 2024-05-06 @ 3:42 PM
Last Modification Date: 2024-10-26 @ 1:54 PM
Study NCT ID: NCT04722861
Status: UNKNOWN
Last Update Posted: 2021-01-25
First Post: 2021-01-21

Brief Title: Development of the Glaucoma Visual Functioning Questionnaire-40 and Its Psychometric Properties
Sponsor: Zhongshan Ophthalmic Center Sun Yat-sen University
Organization: Zhongshan Ophthalmic Center Sun Yat-sen University

Study Overview

Official Title: Development of the Glaucoma Visual Functioning Questionnaire-40 and Its Psychometric Properties
Status: UNKNOWN
Status Verified Date: 2021-01
Last Known Status: ENROLLING_BY_INVITATION
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 worlds 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 HRQOL6-10 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None