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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03967145
Other study ID # ATADEK 2019-7/2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 27, 2019
Est. completion date March 1, 2020

Study information

Verified date April 2020
Source Acibadem University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 127
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Determining quality of life
Quality of Life

Locations

Country Name City State
Turkey Yücel Öztürk Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Acibadem University Haydarpasa Numune Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months
Primary 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. 6 months
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