Accuracy In Diagnosing Polypoidal Choroidal Vasculopathy By Using Color Fundus Photography And Optical Coherence Tomography : A Prospective Study

Purpose:This study were designed to conduct a prospective study based on our previous retrospective clinical research,to accurately diagnose polypoidal choroidal vasculopathy（PCV）in the absence of indocyanine green angiography（ICGA）by using color fundus photography（CFP）and optical coherence tomography（OCT）based on the pre-specified criteria,so as to establish a set of complete,practical and highly accurate diagnostic criteria on non-invasive multi-modal imaging examination,which is able to provide guidance for clinicians to diagnose PCV.Method:This study prospectively recruit patients with new onset of serous or serosanguinous maculopathy who came to the Ophthalmology Department of the Fourth Affiliated Hospital of China Medical University during March 1,2019 to December 31,2020.Each participant underwent CFP and SD-OCT（Spectralis;Heidelberg Engineering,Inc）first.A designated retina specialist made diagnosis whether the patient has PCV or not based on the pre-specified criteria(notched/hemorrhagic PED from CFP and sharp peak PED,notched PED,hyperreflective ring surrounding hyporeflectivity underneath RPE from OCT^[1]).Then,ICGA was required to be done on the same day of within a week.Eventually the clinician would compare the preliminary diagnosis by CFP and OCT with the final diagnosis by ICGA examination.Parameters including sensitivity,specificity,and predictive accuracy using the area under the receiver operating characteristic curve（AUC）,of each feature alone and features combination on CFP,OCT for the diagnosis of PCV（CFP）and optical coherence tomography（OCT）.Results:The study included 21 eyes of 21 Chinese patients（12 males（57.1%）and 9females（42.9%））,with an average age of 68.3（95%CI 64.8-71.8）years.Among these21 eyes,14 eyes（66.7%）were finally diagnosed by experts as PCV,1 eye（4.8%）was typical neovascular age-related macular degeneration,and 6 eyes（28.5%）were other diseases.Among the four main prespecified criteria in our study,the criteria of notched or hemorrhagic PED on CFP had a lower AUC（61.9%）and its accuracy in diagnosing PCV was low.All of the other three criteria,including sharp peak,notched PED and hyperreflective ring surrounding hyporeflectivity underneath RPE from OCT,had a high AUC above 0.8 indicating that these criteria had high accuracy in diagnosing PCV.Identifying PCV by at least one of the four pre-specified criteria provided a high sensitivity of 100%,a high positive predictive value of 87.5%,a high negative predictive value of 100%,and a high accuracy of 90.5%,but a lower specificity of 71.4%.Diagnosing PCV by at least 2 of the pre-specified criteria provided high sensitivity（92.9%）,high specificity（100%）,high positive predictive value（100%）,high negative predictive value（87.5%）and high accuracy（95.2%）.Increasing the minimum number of criteria for combined use,the specificity and positive predictive value of diagnosis were still high（both are still 100%）,but the sensitivity,negative predictive value and accuracy gradually decreased.Conclusion:The accuracy of pre-specified criteria on CFP and OCT to diagnose PCV is high.In the absence of ICGA,PCV can be diagnosed more accurately according to the diagnostic criteria of our study:When at least 2 of 4 main criteria（1.notched/hemorrhagic PED from CFP,2.sharp peak PED,3.notched PED,4.hyperreflective ring surrounding hyporeflectivity underneath RPE from OCT）appear,the diagnosis of PCV has 95.2%accuracy,92.9%sensitivity,100%specificity,100%positive predictive value and 87.5%negative predictive value.