MedTrace Logo

Correlation Between Visual Acuity Measurements, Quality of Life and Morphological Parameters in Wet AMD Patients

NCT03438669 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 53

Last updated 2018-02-20

No results posted yet for this study

Summary

Patient-reported vision-related quality of life (QOL) outcomes are increasingly incorporated into clinical trials of new treatments for age-related macular degeneration (AMD). In patients with central visual field defects they often do not correlate with distance visual acuity changes as evaluated according to the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Therefore there is the need for better correlated visual acuity (VA) outcome measures for these patients. In a current big trial for treatment of dry AMD (geographic atrophy) reading speed and low luminance visual acuity are used as outcome measures for the first time. However, limited information is available regarding the associations between distance ETDRS visual acuity, reading speed, low luminance visual acuity, contrast sensitivity, morphological parameters and the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) subscales judged relevant to these measures. Evaluating these correlations could provide the basis for objective study outcome parameters which are better correlated to patient-reported outcomes. Further it increases the understanding of the impact of visual impairment on activities and functioning in patients with eye diseases.

There is an immediate benefit to the study patients, as they might gain information regarding their individual results regarding objective VA measures, contrast sensitivity (and their impact on reading ability). Furthermore, the results of the study could be beneficial for future patients due to, e.g., a better understanding of the disease, especially regarding factors which have an impact on their near vision ability and therefore their quality of life. The study could provide a basis to find and include outcome measures which are correlated better with quality of life than ETDRS distance VA for further AMD trials.

Conditions

  • Macular Degeneration

Interventions

OTHER

no intervention

no intervention

Sponsors & Collaborators

  • Vista Klinik

    collaborator OTHER

  • Dr. med. Katja Hatz

    lead OTHER

Eligibility

Min Age
55 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-24
Primary Completion
2017-05-30
Completion
2017-10-27

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03438669 on ClinicalTrials.gov