Status:
COMPLETED
Correlation Between Visual Acuity Measurements, Quality of Life and Morphological Parameters in Wet AMD Patients
Lead Sponsor:
Dr. med. Katja Hatz
Collaborating Sponsors:
Vista Klinik
Conditions:
Macular Degeneration
Eligibility:
All Genders
55-100 years
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...
Detailed Description
3.1 Background and Rationale AGE-RELATED MACULAR Degeneration (AMD) is the leading cause of blindness among European descended people older than 65 years. Today, the average life expectancy in develo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 24 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 27 2017
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03438669
Start Date
February 24 2017
End Date
October 27 2017
Last Update
February 20 2018
Active Locations (1)
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1
Vista Klinik
Binningen, Basel-Landschaft, Switzerland, 4102