PRESERFLO ™ MicroShunt versus trabeculectomy: 1-year results on efficacy and safety.

PURPOSE: To compare the efficacy and safety of the PRESERFLO™ MicroShunt versus trabeculectomy in patients with primary open-angle glaucoma (POAG) after one year. PATIENTS AND METHODS: Institutional prospective interventional cohort study comparing eyes with POAG, which had received the PRESERFLO™ MicroShunt versus trabeculectomy. The MicroShunt group was matched with the trabeculectomy group for age, known duration of disease, and number and classes of intraocular pressure (IOP) lowering medications to have similar conjunctival conditions. The study is part of the Dresden Glaucoma and Treatment Study, using a uniform study design, with the same inclusion and exclusion criteria, follow-ups and standardized definitions of success and failure for both procedures. PRIMARY OUTCOME MEASURES: mean diurnal IOP (mdIOP, mean of 6 measurements), peak IOP, and IOP fluctuations. SECONDARY OUTCOME MEASURES: success rates, number of IOP lowering medications, visual acuity, visual fields, complications, surgical interventions, and adverse events. RESULTS: Sixty eyes of 60 patients, 30 in each group, were analyzed after 1-year follow-ups. Median [Q25, Q75] mdIOP (mmHg) dropped from 16.2 [13.8-21.5] to 10.5 [8.9-13.5] in the MicroShunt and from 17.6 [15.6-24.0] to 11.1 [9.5-12.3] in the trabeculectomy group, both without glaucoma medications. Reduction of mdIOP (P = .596), peak IOP (P = .702), and IOP fluctuations (P = .528) was not statistically significantly different between groups. The rate of interventions was statistically significantly higher in the trabeculectomy group, especially in the early postoperative period (P = .018). None of the patients experienced severe adverse events. CONCLUSION: Both procedures are equally effective and safe in lowering mdIOP, peak IOP and IOP fluctuations in patients with POAG, one year after surgery. CLINICAL TRIAL REGISTRATION: NCT02959242.

Evaluation of corneal biomechanical properties using the ocular response analyzer and the dynamic Scheimpflug-Analyzer Corvis ST in high pressure and normal pressure open-angle glaucoma patients.

PURPOSE: To characterize differences in corneal biomechanics in high (HPG) and normal pressure (NPG) primary open-angle glaucoma, and its association to disease severity. METHODS: Corneal biomechanical properties were measured using the Ocular Response Analyzer (ORA) and the dynamic Scheimpflug-Analyzer Corvis ST (CST). Disease severity was functionally assessed by automated perimetry (Humphrey field analyzer) and structurally with the Heidelberg Retina Tomograph. To avoid a possible falsification by intraocular pressure, central corneal thickness and age, which strongly influence ORA and CST measurements, group matching was performed. Linear mixed models and generalized estimating equations were used to consider inter-eye correlation. RESULTS: Following group matching, 60 eyes of 38 HPG and 103 eyes of 60 NPG patients were included. ORA measurement revealed a higher CRF in HPG than in NPG (P < 0.001). Additionally, the CST parameter integrated radius (P < 0.001) was significantly different between HPG and NPG. The parameter SSI (P < 0.001) representing corneal stiffness was higher in HPG than in NPG. Furthermore, regression analysis revealed associations between biomechanical parameters and indicators of disease severity. In HPG, SSI correlated to RNFL thickness. In NPG, dependencies between biomechanical readings and rim area, MD, and PSD were shown. CONCLUSION: Significant differences in corneal biomechanical properties were detectable between HPG and NPG patients which might indicate different pathophysiological mechanisms underlying in both entities. Moreover, biomechanical parameters correlated to functional and structural indices of diseases severity. A reduced corneal deformation measured by dynamic methods was associated to advanced glaucomatous damage.

Efficacy of selective laser trabeculoplasty on lowering intraocular pressure fluctuations and nocturnal peak intraocular pressure in treated primary open-angle glaucoma patients.

PURPOSE: To investigate the efficacy of adjunctive selective laser trabeculoplasty (SLT) in reducing 24-h intraocular pressure (IOP) fluctuations and nocturnal IOP peaks. METHODS: In this prospective interventional case series, 157 medically treated eyes of 157 patients with primary open-angle glaucoma (POAG) who were assigned SLT to further reduce IOP were consecutively included. Each patient had a complete glaucoma work-up and 24-h IOP monitoring (6 measurements, including one in the supine position) taken before and on average 6 months after SLT. The main outcome measures were the reduction of 24-h IOP fluctuations and nocturnal peak IOP. Secondary outcome measures were success rates, factors influencing the reduction of high 24-h IOP fluctuations and nocturnal peak IOP, complications, and severe adverse events. RESULTS: Medicated mean 24-h IOP (mmHg) was statistically significantly reduced from 15.1 ± 2.6 to 13.8 ± 2.4 (P < 0.001) and IOP fluctuations from 6.5 ± 2.7 to 5.4 ± 2.6 (P < 0.001) 6 months after SLT. Ninety-four eyes (59.9%) initially had high IOP fluctuations (more than 5 mmHg). These were reduced from 8.1 ± 2.3 to 5.6 ± 2.7 at 6 months (P < 0.001). Fifty-two eyes (55.3%) had fluctuations below 5 mmHg post-SLT which was defined as success. Fifty-one patients (32.5%) had nocturnal IOP peaks. In these cases, nocturnal IOP was reduced by 19.2% from 20.1 ± 3.4 to 16.2 ± 3.3 mmHg at 6 months (P = 0.001). CONCLUSIONS: The current study demonstrates that adjunctive SLT not only reduces mean 24-h IOP in treated POAG patients, but also has an additional benefit in reducing IOP fluctuations and nocturnal peak IOP. TRIAL REGISTRATION: Clinical trial registration: NCT02959242.

Two-Year Follow-up of MicroPulse Transscleral Laser Therapy in Patients with Primary Open-Angle Glaucoma. / 2-Jahres-Ergebnisse nach transskleraler MicroPulse-Lasertherapie bei Patienten mit primärem Offenwinkelglaukom.

PURPOSE: To determine the long-term efficacy and safety of MicroPulse transscleral laser therapy (TLT) over a 24-month period in patients with primary open angle glaucoma. METHODS: This prospective interventional case series evaluated data from 44 medically treated eyes of primary open angle glaucoma (POAG) patients who received MicroPulse TLT to achieve further reduction in IOP. The reduction in 24-hr mean diurnal intraocular pressure (IOP), diurnal IOP fluctuations, and peak IOP were monitored after 3, 12, and 24 months. Postoperative complications, failure rates, and factors influencing IOP reduction were also evaluated. RESULTS: IOP decreased from 16.1 ± 3.4 mmHg preoperatively to 13.0 ± 2.9 mmHg (n = 31; p < 0.001), 12.3 ± 3.0 mmHg (n = 27; p < 0.001), and 13.1 ± 2.6 mmHg (n = 23; p < 0.001) at the 3-month, 12-month and 24-month follow-ups. At 24 months, 23 eyes (52%) had a sufficient IOP reduction to reach the individual target pressure. No severe complications were observed. No parameters could be identified that correlated with successful IOP reduction after treatment. The highest failure rate was observed during the first 3 months and remained stable thereafter. CONCLUSION: For about 50% of POAG eyes receiving the maximum tolerated treatment, MicroPulse TLT proved an effective method of further lowering IOP so as to reach the individual target pressure.

PRESERFLO™ MicroShunt versus trabeculectomy: first results on efficacy and safety.

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.

Efficacy of Selective Laser Trabeculoplasty on Circadian Intraocular Pressure Following Trabeculectomy in Advanced Primary Open-angle Glaucoma.

PRCIS: In about 50% of post-trabeculectomy (TE) eyes, selective laser trabeculoplasty (SLT) is effective in further lowering intraocular pressure (IOP). PURPOSE: To investigate the efficacy and safety of SLT in post-TE eyes, uncontrolled on maximum tolerated medication, and/or with progression of visual field loss. PATIENTS AND METHODS: This retrospective study consecutively included post-TE eyes of patients diagnosed with primary open-angle glaucoma who had been treated with 360 degrees SLT and had a follow-up after 12 months. Primary endpoints were the reduction of mean diurnal intraocular pressure (mdIOP, mean of 6 measurements), peak IOP, and diurnal IOP fluctuations. Secondary outcomes were factors influencing IOP reduction, SLT success, and failure rates. RESULTS: Forty-three eyes of 43 patients were included. During the first year, 10 eyes (23%) needed additional procedures to reduce mdIOP and were accounted as failures and excluded from final analysis. Of the remaining 33 eyes (77%) mdIOP [Q25, Q75] dropped from 15.2 [12.2 to 16.5] to 13.2 [11.6 to 15.3] mm Hg (P=0.027), 23 eyes (54%) showed a sufficient mdIOP reduction, 1 year after SLT. CONCLUSION: SLT is effective and safe in lowering mdIOP to target IOP in about 50% of eyes after prior incisional glaucoma surgery.

Nocturnal blood pressure in primary open-angle glaucoma.

PURPOSE: To evaluate the nocturnal blood pressure (BP) dipping-pattern in patients with manifest primary open-angle glaucoma (POAG) and to find possible associations with the severity of visual field damage. METHODS: A number of 314 patients suffering from POAG were consecutively enrolled in this cross-sectional hospital-based study. Each patient had diurnal intraocular pressure (IOP) measurements, 24-hr BP monitoring and computerized perimetry with the Humphrey 30-2 sita Standard program. Inclusion criteria were a mean IOP of less than 15 mmHg with fluctuations of less than 5 mmHg and a visual acuity of at least 20/40. One eye was randomly selected. Based on the night-day BP ratio, a mean arterial nocturnal BP drop of less than 10% was considered as non-dipping, between 10% and 20% as physiological dipping and of more than 20% as over-dipping. RESULTS: Glaucoma patients with daytime systemic normotension on the average had more visual field loss in the over-dipper group (MD = - 16.6 dB, IQR = -18.9 to -2.7 dB) than glaucoma patients with daytime systemic hypertension, who had less visual field defects in the over-dipper group (MD = -3.9 dB, IQR = -6.2 to -1.9 dB) (p = 0.004). This result was also found taking age, glaucoma duration, visual acuity, gender, systemic and topical medication as covariates into account. CONCLUSIONS: To judge the nocturnal BP situation of an individual patient, it is important to do this in relation to the daytime BP level. Twenty-four-hour BP evaluation might be important for all patients with POAG, as nocturnal BP could be a modifiable risk factor for glaucoma severity and progression.