NCT05427994

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
458

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

April 5, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2022

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

1.3 years

First QC Date

June 15, 2022

Last Update Submit

August 31, 2022

Conditions

Keywords

age-related macular degenerationquality of lifesocial supportreliability of social supportvision related quality of life

Outcome Measures

Primary Outcomes (1)

  • Quality of life of AMD patients

    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

    at the recruitment to the study

Secondary Outcomes (3)

  • Social Support

    at the recruitment to the study

  • Reliability of Social Support

    at the recruitment to the study

  • Relationship between QOL and social support

    at the recruitment to the study

Study Arms (1)

Patients with age-related macular degeneration

Patients with age-related macular degeneration who fill out the quality of life questionnaire, and answer questions about social support and reliability of social support

Other: National Eye Institute Visual Function Questionnaire

Interventions

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.

Also known as: NEI-VFQ-25
Patients with age-related macular degeneration

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with diagnosed age-related macular degeneration

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kazakh Scientific - Research Institute of Eye Diseases

Almaty, 050012, Kazakhstan

Location

Medical Centre Hospital of President'S Affairs Administration of the Republic of Kazakhstan

Astana, 010000, Kazakhstan

Location

Related Publications (1)

  • Ismayilova I, Turdaliyeva B, Aldasheva N, Veselovskaya N. Assessing the quality of life in age-related macular degeneration patients: a cross-sectional study in Kazakhstan. Acta Biomed. 2022 Dec 16;93(6):e2022299. doi: 10.23750/abm.v93i6.13580.

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Inara Isamyilova, PhD

    Asfendiyarov Kazakh National Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 22, 2022

Study Start

April 5, 2021

Primary Completion

July 27, 2022

Study Completion

July 27, 2022

Last Updated

September 1, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

According to the patient consent form data is not available for scientific use by others than the project group members.

Locations