Subjective evaluation of visual acuity is not reliable to detect disease activity in different exudative maculopathies.
BACKGROUND
Patients with exudative maculopathies (neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO)) are faced with a high burden of examinations and treatments. This study was conceived to analyze the accuracy of a subjective evaluation of visual acuity (VA) and metamorphopsia to detect disease reactivation, compared to morphological signs of reactivation assessed by means of SD-OCT.


METHODS
Retrospective study of 888 patients treated for nAMD (n = 638), DME (84), BRVO (110), and CRVO (56) was conducted. Subjective evaluation of the patient at an examination (i.e., change of VA and/or metamorphopsia) was compared to clinical evaluation of disease activity as assessed by SD-OCT. Sensitivity and specificity, negative and positive predictive values (PPV/NPV) for detection of active disease were calculated. Factors associated with false-negative subjective evaluation were analyzed by regression analysis.


RESULTS
The sensitivity of the subjective evaluation to detect disease reactivation was < 0.50 in all exudative maculopathies. Sensitivity was increased to ≥ 0.60 by combining subjective worsening with loss of 1 line in the VA test in RVO, but not in DME and nAMD. The specificity was > 0.85 in all patients. PPV was > 0.85 in patients with RVO. Regression analysis did not reveal any factors that could reliably identify patient subgroups in which OCT could be omitted, though CRVO patients with a visual acuity of < 0.3 logMAR had an odds ratio of 0.20 for false-negative subjective evaluation (p = 0.009).


CONCLUSION
The accuracy of subjective evaluation to discriminate disease activity in patients with different exudative maculopathies was low and cannot substitute for frequent SD-OCT exams. Routinely assessed clinical parameters such as age, visual acuity, or treatment experience were of no use to predict the validity of subjective evaluation of disease activity.


TRIAL REGISTRATION
This trial was registered at the DRKS (Deutsches Register Klinischer Studien, drks.de; No 00006851) prior to the inclusion of the first patient.
['Bruender|Marie-Christine|MC|', 'Benjamin|Nicola|N|', 'Agostini|Hansjuergen Thomas|HT|', 'Stahl|Andreas|A|', 'Ehlken|Christoph|C|http://orcid.org/0000-0001-7388-7173']
D000368:Aged D000369:Aged, 80 and over D003930:Diabetic Retinopathy D003937:Diagnosis, Differential D005260:Female D005500:Follow-Up Studies D006801:Humans D008269:Macular Edema D008297:Male D015203:Reproducibility of Results D012160:Retina D012189:Retrospective Studies D012720:Severity of Illness Index D013997:Time Factors D041623:Tomography, Optical Coherence D014786:Vision Disorders D014792:Visual Acuity D057135:Wet Macular Degeneration
Maculopathy Macular edema Sensitivity Specificity Diagnosis Diagnostic accuracy