Abstract
Purpose :
To study differences in intraocular pressure (IOP) lowering efficacy and safety after 2-year follow-up of the PRESERFLOTM MicroShunt compared to the gold standard glaucoma surgery, which is trabeculectomy, in patients with primary open-angle glaucoma (POAG).
Methods :
In this institutional prospective interventional cohort study, the MicroShunt group was consecutively included and matched with the trabeculectomy group for age, known duration of disease, as well as number and classes of topical IOP-lowering medication to assure similar conjunctival conditions. Although the study was not randomized, it is part of a large study using a uniform study design, with the same criteria for inclusion and exclusion, follow-up intervals as well as standardized definitions of success and failure. The reduction of mean diurnal IOP (mdIOP, mean of 6 measurements), peak IOP, and IOP fluctuations, the use of glaucoma medical therapy, and adverse events after 2 years were the main outcome measures. Statistical analyses used SPSS 28, Mann-Whitney U test, and Wilcoxon test.
Results :
Twenty-six eyes of 26 POAG patients were analyzed in each group after 2-year follow-up. Median [Q25, Q75] mdIOP was reduced from 16.3 [13.8-20.8] mmHg using 4.0 [3.0 - 4.0] glaucoma medications to 11.8 [10.7-12.8] mmHg with no glaucoma medications in the MicroShunt group, and in the trabeculectomy group from 17.3 [15.2-21.8] mmHg with 4.0 [3.0 - 4.0] glaucoma medications to 11.2 [8.8-13.0] mmHg without any glaucoma medications. There was no statistical significant difference between both groups regarding the reduction of mdIOP (p=0.204), peak IOP (p=0.112), and IOP fluctuations (p=0.889). No severe adverse events were seen.
Conclusions :
Both procedures show equal efficacy and safety in lowering mdIOP, peak IOP and IOP fluctuations in patients with POAG after 2 years.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.