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

NCT03438669 | Completed

• 1 other identifier: COSP /EKNZ2016-02216
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

visual acuity; ETDRS; quality of life

Outcome Measures

Primary Outcomes (1)

• The primary analysis will be to evaluate if there is a correlation between NEI-VFQ-25 near distance subscale and reading speed

  Pearson correlation between NEI VFQ-25 (National Eye Institute Visual Function Questionnaire) near visual acuity sub scale score (questions 5,6,7) (maximum score 1, minimum score 6, higher score indicates worse vision related to quality of life)

  2 hours

Secondary Outcomes (4)

• Correlation between NEI VFQ-25 near visual acuity subscale score and low luminance visual acuity score

  2 hours

• Correlation between NEI VFQ-25 near visual acuity subscale score and contrast sensitivity score

  2 hours

• Correlation between NEI VFQ-25 near visual acuity subscale score and near visual acuity subscale score

  2 hours

• Correlation between NEI VFQ-25 near visual acuity subscale score and size of hypo-autofluorescent lesions (mm2) at autofluorescence

  2 hours

Interventions

no intervention OTHER

no intervention

Eligibility Criteria

• Age: 55 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Age: ≥ 55 years ( to 100 years) * patients will be required to have a confirmed diagnosis of wet AMD (including early, intermediate and advanced) from an ophthalmologist at the Vista Klinik, Binningen.

Incl.Crit. * To be eligible for participation, patients will be required to have a confirmed diagnosis of wet AMD (including early, intermediate and advanced) from an ophthalmologist at the Vista Klinik, Binningen. * Best-corrected visual acuity letter score of ≥ 49 letters (Snellen equivalent of 20/100 or better) using ETDRS charts at a distance of 4m. * Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging * Age: ≥ 55 years ( to 100 years) * Wet AMD patients with lesions within the central 1mm ETDRS Grid subfield foveal zone. (The patient has to have a lesion within the 1mm central zone in the better eye). Although foveal involvement is required, lesions underneath the Foveola is not necessary. The maximum distance a lesion should be from the central point is 500µm. Excl. Crit. * Significant ocular disease, for example, recurrent infectious or inflammatory ocular disease. * Patients who received treatment for CNV within the previous 4 days or who had an acute illness or a history of neurologic disease or cognitive impairment that would interfere with study requirements will not be eligible * The research will be conducted in accordance with the tenets of the Declaration of Helsinki. Informed consent will be obtained from all patients before testing. Thus, all patients not signing informed consent will be excluded from the study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Dr. med. Katja Hatz: lead
• Vista Klinik: collaborator

Study Sites (1)

Vista Klinik

Binningen, Basel-Landschaft, 4102, Switzerland

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Medical Retina Department

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: February 20, 2018
• Study Start: February 24, 2017
• Primary Completion: May 30, 2017
• Study Completion: October 27, 2017
• Last Updated: February 20, 2018

Record last verified: 2018-01

Locations

CH (1)