Purpose
To report efficacy and safety outcomes of the PRESERFLO™ MicroShunt compared with trabeculectomy, the current gold‐standard treatment for advanced glaucoma, in the early and intermediate postoperative period.
Methods
Institutional prospective interventional cohort study of primary open‐angle glaucoma (POAG) patients scheduled for the PRESERFLO™ MicroShunt. The comparison group were POAG patients who had had received trabeculectomy and were matched for age, known duration of disease, number and classes of intraocular pressure (IOP)‐lowering medications to ensure a similar conjunctival condition. The study is part of the Dresden Glaucoma and Treatment Study (DGTS), was not randomized, but used a uniform study design, with the same inclusion and exclusion criteria as well as standardized definitions of success and failure. Main outcome measures: mean diurnal IOP (mdIOP, mean of 6 measurements), diurnal peak IOP, diurnal IOP fluctuations, glaucoma medical therapy, success rates, visual acuity, visual fields, surgical complications and interventions, and severe adverse events.
Results
Fifty‐two eyes of 52 patients, 26 in each group, were analysed. At 6 months, median [Q25, Q75] mdIOP was 10.8 [9.5–12.2] mmHg in the microshunt and 10.3 [7.6–11.8] mmHg in the trabeculectomy group. Reduction in mdIOP (p = 0.458), peak diurnal IOP (p = 0.539), and median diurnal fluctuation (p = 0.693) was not statistically significantly different between groups. The rate of interventions was statistically significantly higher in the trabeculectomy compared with the microshunt group (p = 0.004). None of the patients experienced severe adverse events.
Conclusion
Both procedures are equally effective and safe in lowering mdIOP in patients with POAG. Because the microshunt is less invasive with less follow‐up and interventions needed postoperatively, it might be recommended earlier in the treatment of glaucoma.
Background
To test the ability of the newly calculated Dresden biomechanical glaucoma factor (DBGF) based on dynamic corneal response (DCR) deformation and corneal thickness parameters, to discriminate between healthy and normal pressure glaucoma (NPG) eyes.
Methods
Seventy healthy and 70 NPG patients of Caucasian origin were recruited for this multicentre cross‐sectional pilot study, which included both eyes for analysis. Logistic regression analysis with generalized estimating equation (GEE) models to account for correlations between eyes and a threefold cross‐validation were performed to determine the optimal combination of Corvis ST parameters in order to separate normal from NPG eyes.
Results
The DBGF was calculated using 5 Corvis ST parameters, which showed the best discrimination power: deformation amplitude ratio progression, highest concavity time, pachymetry slope, the biomechanically corrected intraocular pressure and pachymetry. In a threefold cross‐validation, the receiver operating characteristic (ROC) curve confirmed an area under the curve (AUC) of 0.814 with a sensitivity of 76% and a specificity of 77% using a logit cut‐off value of a DBGF = 0.5.
Conclusion
The DBGF shows to be sensitive and specific to discriminate healthy from NPG eyes. Since diagnosis of NPG is often challenging, the DBGF may help with the differential diagnosis of NPG in daily clinical practice. Therefore, it might be considered as a new possible screening method for NPG.
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