Skip to main content
OpenTrials
Completed

NCT Number: NCT05427994

Assessing the Quality of Life and Social Support in Age-Related Macular Degeneration Patients

The aim of this study is to evaluate the quality of life of AMD patients related to vision using the short version of the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25), patients' social support, and their relationship with demographic and clinical variables.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kazakh Scientific - Research Institute of Eye Diseases, Almaty, Kazakhstan

Loading trial locations.

About this study

Background and study aims. Age-related macular degeneration (AMD) is the most prevalent chronic progressive ocular disease. It has been shown in several studies that AMD affects the quality of life of patients. The aim of this study is to evaluate the quality of life of AMD patients related to vision using the short version of the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25), patients' social support, and their relationship with demographic and clinical variables.

Who can participate? Patients with AMD, who wish to participate, will be recruited. Patients will be recruited from three locations of the Kazakh Scientific - Research Institute of Eye Diseases in Almaty, Nur-Sultan and Shymkent.

What does the study involve? The study involves collecting demographic data of the participants, collecting baseline visual testing data from medical records, filling out of the NEI-VFQ-25, and answering two yes/no questions related to the social support and reliability of social support.

What are possible benefits and risks of participating? Assessment of quality of life and social support of the AMD patients is a first step of developing targeted psycho-social support programs for AMD patients.

Where is the study run from? Patients will be recruited from three locations of the Kazakh Scientific - Research Institute of Eye Diseases in Almaty, Nur-Sultan and Shymkent.

When is the study starting and how long it is expected to run for? Start date 03/02/2020. End date 27/08/2022.

Who is funding the study? No funding for this study. Who is the main contact? Principal investigator: Inara Ismailova; +380 73 200 0688; [email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age-related macular degeneration; ability to speak and understand Russian and/or Kazakh language; willingness to participate

Exclusion criteria

  • Presence of glaucoma, cataracts of grade 2 or more according to the Lens Opacities Classification System (LOCS) III, and the presence of corneal opacities or any other retinal diseases

Treatment and study plan

National Eye Institute Visual Function Questionnaire

Other

National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) measures the quality of life related to vision. This questionnaire has been validated for use on low vision patients.

Other names: NEI-VFQ-25

Primary outcomes

  1. Quality of life of AMD patients

    Time frame: at the recruitment to the study

    Vision related Quality of life (QOL) of AMD patients related to vision assessed by NEI-VFQ-25 total score at the recruitment. NEI-VFQ-25 has 38 questions with multiple choice answers, each rated 0,25, 50, 75 or 100. The overall score is measured as a mean of all answers

Secondary outcomes

  1. Social Support

    Time frame: at the recruitment to the study

    Percentage of AMD patients with Social Support. Social Support of AMD patients at the recruitment assessed by answering a yes/no question.

  2. Reliability of Social Support

    Time frame: at the recruitment to the study

    Percentage of AMD patients with a reliable Social Support. Reliability of Social Support of AMD patients at the recruitment assessed by answering a yes/no question.

  3. Relationship between QOL and social support

    Time frame: at the recruitment to the study

    Correlation between the overall quality of life of AMD patients and demographic, visual characteristics, and social support tested with multiple linear regression model. The Hosmer-Lemeshow goodness-of-fit test will be used to test the model's fit. All tests will be two-tailed with a significance level of 0.05.

Sponsors and collaborators

Lead sponsor

Asfendiyarov Kazakh National Medical University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 22, 2022
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.