NCT03967145

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

May 27, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

9 months

First QC Date

May 27, 2019

Last Update Submit

April 7, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

Quality of Life

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Primary Open-Angle Glaucoma patients

You may qualify if:

  • Diagnosis of primary open angle glaucoma more than 6 months with visual field tests,
  • Have the sufficient cognitive level to answer the scale questions.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yücel Öztürk

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Özgül Öztürk

    Acibadem University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 27, 2019

First Posted

May 30, 2019

Study Start

May 27, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

April 8, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations