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:
The myopic CNV is a neovascularization starting from the choroid and growing into the space
between choroid and retina, based on pathological myopia (severe myopia). Choroidal
neovascularization secondary to pathological myopia (mCNV) is the most common cause of severe
visual impairment in myopic patients younger than 50 years old.1 As untreated subretinal
fibrovascular membranes cause rapid damage to the photoreceptors, timely treatment is
required in view of poor spontaneous prognosis.1
Metamorphopsia is the first functional impairment which occurs in mCNV - visual acuity loss
and scotoma follow later. The Amsler Grid, a qualitative paper test developed the swiss
ophthalmologist Marc Amsler (1891 - 1968), is a square-shaped grid used to detect or monitor
metamorphopsia or scotoma involving the central visual field in various disorders of the
macula and optic nerve head11.
Myopic CNV patients use the Amsler Grid as a home monitoring device for qualitative detection
of metamorphopsia by checking the grid regularly11. Due to subretinal scarring in mCNV
interpretation is often difficult and early changes cannot be detected and quantified. Until
now there are no quantitative measurements for mCNV monitoring in clinical use.
Recently, two devices to detect and monitor metamorphopsia using smart phones and PCs,
respectively, have been developed for use in choroidal neovascularization in age-related
macular degeneration.5,6
- 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.5
- 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.6
This study was designed to find out whether these metamorphopsia applications are suitable
for patients with mCNV and to find out if mCNV patients can benefit for a quicker detecting
of the metamorphopsia.
Therefore, 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.
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