NCT04112524|Completed
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Sponsor study identifier
observational
23
1 country
1
Study Start
October 8, 2019
Actual (reported)Primary Completion
February 2, 2021
Actual (reported)Study Completion
February 2, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 30, 2019
Actual (reported)October 2, 2019
Actual (reported)October 8, 2019
Actual (reported)February 2, 2021
Actual (reported)February 2, 2021
Actual (reported)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
CRT (central retinal thickness) measured in OCT
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
1 year
NEI VFQ-25 questionnaire -BCVA (best corrected visual acuity)
1 year
all 30 patients from Routine Treatment, only observational
* 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
patients in retina- routine control
Vista Klinik
Binningen, Basel-Landschaft, 4102, Switzerland
23 participants (actual enrollment reported by the registry).
First Submitted
September 30, 2019
First Posted
October 2, 2019
Study Start
October 8, 2019
Actual (reported)Reducing Anxiety Levels Through the Dharma Life App-Based and Mentor-Based Program Targeting Personality Characteristics: A Randomized Control Trial
Remote Symptom Review in Patients With Implantable Diagnostic Holter
Contact the study team to confirm eligibility.
Primary Completion
February 2, 2021
Actual (reported)Study Completion
February 2, 2021
Actual (reported)Last Updated
December 9, 2021
Record last verified: 2021-12
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Source: ClinicalTrials.gov.
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