GlaucomaNCT03967145
Turkish Version of the Glaucoma Quality of Life-15 Questionnaire
An observational study of Glaucoma and Quality of Life, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Glaucoma is a disease with irreversible loss of visual field and optic neuropathy and is the most important cause of irreversible vision loss after cataract in the world. Although clinical evaluations reveal the level of glaucoma quantitatively, it is necessary to evaluate the impact of this pathology on daily… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Glaucoma, Quality of Life
- What is being tested?
- Determining quality of life
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 127 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 May 2019to 1 Mar 2020
- 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 20 to 60 years
- All sexes
- Adult
Study population: Primary Open-Angle Glaucoma patients
Who may be able to join
- Diagnosis of primary open angle glaucoma more than 6 months with visual field tests,
- Have the sufficient cognitive level to answer the scale questions.
Who cannot join
- To have retinal or optic nerve pathologies that may cause loss of visual field or decrease in visual field except glaucoma,
- To undergo eye surgery in the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability and Validity of the Turkish Version of the Glaucoma Quality of Life-15 Questionnaire
Glaucoma is a disease with irreversible loss of visual field and optic neuropathy and is the most important cause of irreversible vision loss after cataract in the world. Although clinical evaluations reveal the level of glaucoma quantitatively, it is necessary to evaluate the impact of this pathology on daily functions and quality of life with a holistic perspective and to provide appropriate advice to patients according to the information obtained. Glaucoma Quality of Life -15 Questionnaire (GQoL-15) was developed by Nelson et al. in 2003 to evaluate the quality of life of glaucoma patients. The aim of this study is to translate GQoL-15 into Turkish and evaluate its test-retest reliability for Turkish-speaking population.
- Conditions
- Glaucoma, Quality of Life
- Being tested
- Determining quality of life
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determining quality of lifeBehavioural
Quality of Life
What is being measured
The primary outcome is the main question the study is designed to answer.
Glaucoma Quality of Life 15 Questionnaire total score
GQoL-15 total score was got after calculate the all subscale values. Subscales are as; 1) Central and near vision (two questions); 2) Peripheral vision (six questions); 3) Dark adaptation (six questions); 4) Outdoor mobility (one question). The item responses for each factor are marked on a five-point scale (1 meaning no difficulty and 5 meaning severe difficulty), 0 is marked if the participant does not perform the activity because of non-visual causes. Higher GQL-15 total scores and subscale scores are reveals lower QoL.
Measured: 6 months
25-item National Eye Institute Visual Functioning Questionnaire (NEI-VFQ 25)
NEI-VFQ 25 total score was got after calculate the all values. It is comprised of 25 items which are; general health and vision, ocular pain, difficulty with vision activities, distance-vision activities, limitation of social functioning, mental health problems, role limitations, dependency on others, driving difficulties, difficulty with color vision and difficulty with peripheral vision. A total score of NEI-VFQ 25 is generated by averaging the scores of all subscales except general health. The item responses for factors are marked on a five or six point scale. Subscale score can be calculated, overall total lower score indicates better vision-related QoL.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start27 May 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Haydarpasa Numune Training and Research Hospital
- Responsible party
- Principal investigator, Özgül Öztürk, Acibadem University
- Investigators
- Özgül Öztürk, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967145
- Sponsor's protocol ID
- ATADEK 2019-7/2
- Status last verified
- Apr 2020
- First submitted
- 27 May 2019
- Last updated
- 8 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Version of the Glaucoma Quality of Life-15 Questionnaire
- ClinicalTrials.gov ID
- NCT03967145
- Acronym / sponsor ID
- ATADEK 2019-7/2
- Conditions
- Glaucoma, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Collaborators
- Haydarpasa Numune Training and Research Hospital
- Study start
- 27 May 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 30 May 2019 (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.
Glaucoma is a disease with irreversible loss of visual field and optic neuropathy and is the most important cause of irreversible vision loss after cataract in the world. Although clinical evaluations reveal the level of glaucoma quantitatively, it is necessary to evaluate the impact of this pathology on daily functions and quality of life with a holistic perspective and to provide appropriate advice to patients according to the information obtained. Glaucoma Quality of Life -15 Questionnaire (GQoL-15) was developed by Nelson et al. in 2003 to evaluate the quality of life of glaucoma patients. The aim of this study is to translate GQoL-15 into Turkish and evaluate its test-retest reliability for Turkish-speaking population.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Primary Open-Angle Glaucoma patients
Key inclusion criteria (2 listed)
- Diagnosis of primary open angle glaucoma more than 6 months with visual field tests,
- Have the sufficient cognitive level to answer the scale questions.
Key exclusion criteria (2 listed)
- To have retinal or optic nerve pathologies that may cause loss of visual field or decrease in visual field except glaucoma,
- To undergo eye surgery in the last 3 months.
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 |
|---|---|---|
| Determining quality of lifeQuality of Life | Behavioural | – |
Primary outcome
Glaucoma Quality of Life 15 Questionnaire total score
Time frame: 6 months
GQoL-15 total score was got after calculate the all subscale values. Subscales are as; 1) Central and near vision (two questions); 2) Peripheral vision (six questions); 3) Dark adaptation (six questions); 4) Outdoor mobility (one question). The item responses for each factor are marked on a five-point scale (1 meaning no difficulty and 5 meaning severe difficulty), 0 is marked if the participant does not perform the activity because of non-visual causes. Higher GQL-15 total scores and subscale scores are reveals lower QoL.
25-item National Eye Institute Visual Functioning Questionnaire (NEI-VFQ 25)
Time frame: 6 months
NEI-VFQ 25 total score was got after calculate the all values. It is comprised of 25 items which are; general health and vision, ocular pain, difficulty with vision activities, distance-vision activities, limitation of social functioning, mental health problems, role limitations, dependency on others, driving difficulties, difficulty with color vision and difficulty with peripheral vision. A total score of NEI-VFQ 25 is generated by averaging the scores of all subscales except general health. The item responses for factors are marked on a five or six point scale. Subscale score can be calculated, overall total lower score indicates better vision-related QoL.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- 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.
Özgül Öztürk principal investigator
Acibadem University
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 Glaucoma and Quality of Life, run by Acibadem University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 8 Apr 2020. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glaucoma Quality of Life 15 Questionnaire total score (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2020.