- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03967145
Turkish Version of the Glaucoma Quality of Life-15 Questionnaire
April 7, 2020 updated by: Özgül Öztürk, Acibadem University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
127
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
İstanbul, Turkey
- Yücel Öztürk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 58 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Primary Open-Angle Glaucoma patients
Description
Inclusion Criteria:
- Diagnosis of primary open angle glaucoma more than 6 months with visual field tests,
- Have the sufficient cognitive level to answer the scale questions.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Özgül Öztürk, Acibadem University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 27, 2019
Primary Completion (Actual)
March 1, 2020
Study Completion (Actual)
March 1, 2020
Study Registration Dates
First Submitted
May 27, 2019
First Submitted That Met QC Criteria
May 29, 2019
First Posted (Actual)
May 30, 2019
Study Record Updates
Last Update Posted (Actual)
April 8, 2020
Last Update Submitted That Met QC Criteria
April 7, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATADEK 2019-7/2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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