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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04112524
Other study ID # Metamorphopsia Study
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 8, 2019
Est. completion date February 2, 2021

Study information

Verified date December 2021
Source Vista Klinik
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The myopic CNV (mCNV) is a blood vessel neoplasm starting from the choroid, based on pathological myopia (severe myopia). Choroidal neovascularization secondary to pathological myopia is the most common cause of severe visual impairment in myopic patients younger than 50 years old. Because untreated small fibrovascular membranes cause rapid damage to the photoreceptors, timely treatment is required in view of poor spontaneous prognosis1. Metamorphopsia is the first functional impairment which occurs in mCNV - visual acuity loss and scotoma follow later. There is a need for better and quicker quantifying of the metamorphopsia in mCNV patients. The aim of this study is to detect metamorphopsia and verify correlations of different indexes with disease activity or not, measured in Optical Cohorence Tomography (OCT), best corrected visual acuity (BCVA), Vision related quality of life questionnaire (NEI-VFY-25) and quantify severity of metamophopsia.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
App
Alleye® Test Alleye® Test is a mobile medical software application indicated for the detection and characterization of metamorphopsia. For the mean Alleye score (±standard deviation (SD) deviations of dots from an ideal line are calculated for each eye. AMD-A Metamorphopsia Detector® Is based on the Amsler grid. The software uses the concept of a negative image: a distorted image can be straightened by moving the mouse. Degree and dimension of distorted lines or scotoma are transformed into indices.

Locations

Country Name City State
Switzerland Vista Klinik Binningen Baselland

Sponsors (1)

Lead Sponsor Collaborator
PD Dr. med. Katja Hatz

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Metamorphopsia index change from baseline (no mCNV activity) to month 6 and 12 and all visits in between (disease activity dependent) for the following two devices - AMD-A Metamorphopsia Detector® (app4eyes - TEST) - Alleye® Test Metamorphopsia index change (disease activity) 1 year
Secondary CRT (central retinal thickness) measured in OCT CRT change (disease activity) 1 year
Secondary -outer retina disruption score within central 1mm (measured in OCT) -maximum CNV thickness within central 1mm (measured in OCT) -area of pigment epithelium atrophy within central 1mm measured in autofluorescence imaging Change of outer Retina disruption score and maximum CNV thickness 1 year
Secondary NEI VFQ-25 questionnaire -BCVA (best corrected visual acuity) Change in BCVA 1 year
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