This research project intends to observe patients with high myopia who show pathological retinal changes, in order to evaluate more data on the risk factors for developing mCNV within this research project population in Germany.
Study Type
OBSERVATIONAL
Enrollment
153
SD-OCT, fundus autofluorescence, fundus photography, optional microperimetry, ophthalmic exams (BCVA, optical biometry), blood sampling.
Novartis Investigative Site
Regensburg, Bavaria, Germany
Change in retinal morphology by SD-OCT
To exploratively determine the pathogenesis within the project population by assessing and evaluating the risk factors of myopic CNV by measuring the change in retinal morphology with spectral domain optical coherence tomography (SD-OCT). Risk factors are defined as choroidal thinning \< 50μm, choroidal curvature length \> 6300 μm (nasal temporal), lacquer cracks, patchy atrophy \> 5mm² and preexisting myopic CNV in second eye.
Time frame: Baseline, first year, 2nd year, 3rd year
Change in retinal morphology by fundus autofluorescence
To exploratively determine the pathogenesis within the project population by assessing and evaluating the risk factors of myopic CNV within the project population by measuring the change in retinal morphology with fundus autofluorescence. Risk factors are defined as choroidal thinning \< 50μm, choroidal curvature length \> 6300 μm (nasal temporal), lacquer cracks, patchy atrophy \> 5mm² and preexisting myopic CNV in second eye.
Time frame: Baseline, first year, 2nd year, 3rd year
Change in retinal morphology by fundus photography
To exploratively determine the pathogenesis within the project population by assessing and evaluating the risk factors of myopic CNV within the project population by measuring the change in retinal morphology with fundus photography. Risk factors are defined as choroidal thinning \< 50μm, choroidal curvature length \> 6300 μm (nasal temporal), lacquer cracks, patchy atrophy \> 5mm² and preexisting myopic CNV in second eye.
Time frame: Baseline, first year, 2nd year, 3rd year
Change in Best Corrected Visual Acuity (BCVA) by vision testing (Landolt chart or equivalent)
To exploratively determine the pathogenesis within the project population and within the individual patient by change of BCVA from baseline to 3rd year.
Time frame: Baseline, 3rd year
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Novartis Investigative Site
Ansbach, Germany
Novartis Investigative Site
Bad Rothenfelde, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Bochum, Germany
Novartis Investigative Site
Bonn, Germany
Novartis Investigative Site
Chemnitz, Germany
Novartis Investigative Site
Cologne, Germany
Novartis Investigative Site
Düsseldorf, Germany
...and 16 more locations
Change in refraction error by autorefractometer
To exploratively determine the pathogenesis within the project population and within the individual patient by change of refraction error from baseline to 3rd year.
Time frame: Baseline, 3rd year