- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04112524
Comparison of Quantitative Metamorphopsia- Measurements in Patients With mCNV
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.
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Baselland
-
Binningen, Baselland, Switzerland, 4102
- Vista Klinik
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- diagnosis of mCNV involving the juxtafoveal or/and foveal region
- BCVA >0.1 (20/200, Snellen)
- ability to follow the study procedures
- given written consent to participation
- >18 years
Exclusion Criteria:
- history of vitreoretinal surgery (including membrane peeling and retinal detachment surgery) to the study eye
- presence of macula foramen or epiretinal membrane with significant distortion of retinal architecture
- history of any side effects to Tropicamide eye drops
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients from routine treatment
all 30 patients from Routine Treatment, only observational
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 1 year
|
Metamorphopsia index change (disease activity)
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CRT (central retinal thickness) measured in OCT
Time Frame: 1 year
|
CRT change (disease activity)
|
1 year
|
-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
Time Frame: 1 year
|
Change of outer Retina disruption score and maximum CNV thickness
|
1 year
|
NEI VFQ-25 questionnaire -BCVA (best corrected visual acuity)
Time Frame: 1 year
|
Change in BCVA
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Metamorphopsia Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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