Primary GlaucomaNCT04722861
Development of the Glaucoma Visual Functioning Questionnaire-40 and Its Psychometric Properties
An observational study of Primary Glaucoma and Glaucoma Suspect, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Glaucoma, Glaucoma Suspect
- What is being tested?
- GVFQ-40
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 8 Sep 2020to 30 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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:
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
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.
Read the 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 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).
- Conditions
- Primary Glaucoma, Glaucoma Suspect
- Being tested
- GVFQ-40
- Medical subject headings
- Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GVFQ-40Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Primary Glaucoma | Patients with primary glaucoma diagnosed by glaucoma professionals Receives: Other: GVFQ-40 | |
| 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. Receives: Other: GVFQ-40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. 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.
Measured: 1 day (Only once)
Secondary outcomes (6)
Diagnosis and treatment information of ophthalmopathy
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.
Measured: 1 day (Only once)
NEI VFQ-25
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.
Measured: 1 day (Only once)
ETDRS visual acuity
The information of ETDRS visual acuity was obtained from the hospital electronic medical record system or outpatient medical record data.
Measured: 1 day (Only once)
Intraocular pressure
The information of intraocular pressure was obtained from the hospital electronic medical record system or outpatient medical record data.
Measured: 1 day (Only once)
Automatic perimetry report
Automatic perimetry reports were obtained from the hospital electronic medical record system or outpatient medical record data.
Measured: 1 day (Only once)
Pelli-Robson contrast sensitivity
Pelli-Robson contrast sensitivity test card was used.
Measured: 1 day (Only once)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start8 Sep 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion30 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722861
- Sponsor's protocol ID
- 2020KYPJ186
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2021
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30273622Sivaprasad 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.
PubMed 29530781Huang 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. 2023 Aug;107(8):1086-1091. doi: 10.1136/bjophthalmol-2021-320985. Epub 2022 Apr 4.
PubMed 35379597
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the Glaucoma Visual Functioning Questionnaire-40 and Its Psychometric Properties
- ClinicalTrials.gov ID
- NCT04722861
- Acronym / sponsor ID
- 2020KYPJ186
- Conditions
- Primary Glaucoma, Glaucoma Suspect
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Glaucoma | – | Other: GVFQ-40Patients with primary glaucoma diagnosed by glaucoma professionals |
| Glaucoma Suspect Controls | – | Other: GVFQ-40Glaucoma 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (11 listed)
- age ≥ 18 years old;
- being able to express clearly and cooperate with the investigators;
- diagnosed with primary glaucoma;
- complete clinical data.
- age ≥ 18 years old;
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GVFQ-40GVFQ-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. | Other | Glaucoma Suspect Controls, Primary Glaucoma |
Primary outcome
GVFQ-40
Time frame: 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.
6 secondary outcomes
Diagnosis and treatment information of ophthalmopathy
Time frame: 1 day (Only once)
NEI VFQ-25
Time frame: 1 day (Only once)
ETDRS visual acuity
Time frame: 1 day (Only once)
Intraocular pressure
Time frame: 1 day (Only once)
Automatic perimetry report
Time frame: 1 day (Only once)
Pelli-Robson contrast sensitivity
Time frame: 1 day (Only once)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Background: PubMed 30273622Jones 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.
- Results publication: PubMed 29530781Sivaprasad 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.
- Derived from this study: PubMed 35379597Huang 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. 2023 Aug;107(8):1086-1091. doi: 10.1136/bjophthalmol-2021-320985. Epub 2022 Apr 4.
- VFQ-25Link provided by the sponsor.
- Randomized Controlled TrialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Glaucoma and Glaucoma Suspect, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GVFQ-40 (time frame: 1 day (Only once)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04722861, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.