Mid-Term Evaluation of iStent Inject® Trabecular Micro-Bypass Stent Implantation with or without Phacoemulsification: A Retrospective Study.

INTRODUCTION: This study evaluated the 6-month performance and safety of micro-invasive glaucoma surgery (MIGS) with iStent inject either with or without cataract surgery. MATERIAL AND METHODS: Longitudinal retrospective study of 86 surgeries in 49 patients with inadequately controlled open-angle glaucoma (OAG) or ocular hypertension who underwent iStent inject trabecular micro-bypass implantation either alone (isolated group) or combined with cataract surgery (combined group). The two primary outcomes included an intraocular pressure (IOP) drop of ≥20% versus preoperative values (adequate drop) and IOP maintenance between 6 and 18 mmHg (adequate Range). For both outcomes, we determined "complete" and "qualified" success if patients did not require or did require glaucoma medications, respectively, at the end of follow-up. Safety outcomes included best-corrected visual acuity, adverse events, and secondary surgeries. RESULTS: In the adequate drop analysis, 30.2% achieved "complete success," and 37.2% achieved "qualified success." For adequate range, 40.7% achieved "complete success" and 39.5% achieved "qualified success." There was no difference in medication decrease (p=0.77) nor IOP reduction (p=0.46) between the isolated and combined groups. Safety was generally favorable and similar between groups, with mild transient adverse events that resulted in no sequelae. DISCUSSION/CONCLUSION: iStent inject implantation either with or without cataract surgery was able to safely decrease IOP and medication requirements through 6 months after surgery.

Safety and efficacy of fixed-combination travoprost/timolol in patients with open-angle glaucoma or ocular hypertension not controlled with timolol monotherapy.

OBJECTIVE: To assess the intraocular pressure (IOP)-lowering effect of travoprost 0.004%/timolol 0.5% fixed-dose combination (TRAV/TIM-FC) in patients not achieving the target IOP of ≤18 mmHg while on timolol 0.5% (TIM) monotherapy. METHODS: A multicenter, prospective, open-label study (NCT01336569) was conducted in patients with open-angle glaucoma or ocular hypertension. Eligible patients were receiving TIM monotherapy with a screening/baseline IOP of 19-35 mmHg in ≥1 eye. TIM was discontinued on the baseline visit day (no washout period) and TRAV/TIM-FC was initiated and administered once daily at 8 pm for 4-6 weeks. The primary efficacy variable was mean change in IOP from TIM-treated baseline to study end, measured by Goldmann applanation tonometry. Results were analyzed by analysis of variance and paired samples t-test (5% significance). RESULTS: A total of 49 patients were enrolled (mean age, 63 [range, 42-82] years; 55.1% White; 73.5% women), and 45 were included in the intent-to-treat (ITT) population. Mean duration of treatment with TRAV/TIM-FC was 31 days. Mean ± standard deviation IOP reduction from baseline (TIM) to the follow-up visit (TRAV/TIM-FC) was -5.0±3.6 mmHg. IOP decreased significantly (P<0.0001) from baseline (22.1±2.6 mmHg) to study end (17.1±3.9 mmHg) in the ITT population, with a mean IOP reduction of 22.3%. Most patients (n=33/45; 73.3%) achieved IOP ≤18 mmHg. Two patients experienced a total of four adverse events (AEs), including a patient who reported one serious AE (enterorrhagia) that was considered unrelated to treatment, and a patient who reported one event each of drug-related redness, pruritus, and foreign body sensation. Most patients (n=47/49; 95.9%) reported no AEs. CONCLUSIONS: TRAV/TIM-FC lowered IOP in patients who were not at target IOP while receiving TIM monotherapy, with most patients achieving an IOP ≤18 mmHg with TRAV/TIM-FC. TRAV/TIM-FC was well tolerated in this population.

Comparison of dynamic contour tonometry and Goldmann applanation tonometry in relation to central corneal thickness in primary congenital glaucoma.

BACKGROUND: To compare intraocular pressure (IOP) measurements obtained with dynamic contour tonometer (DCT) and Goldmann applanation tonometer (GAT), and to investigate their relationship to central corneal thickness (CCT) in primary congenital glaucoma (PCG) eyes. METHODS: Thirty-one eyes of 31 PCG patients (25.7 ± 7.2 years old) were examined. PCG was defined as elevated IOP, enlarged corneal diameter (buphthalmos), Haab's striae and abnormal findings at gonioscopy. The mean of three measurements of GAT, DCT (quality scores 1 and 2), and CCT were obtained and assessed for agreement by means of Bland-Altman plot and for Spearman correlation test. RESULTS: Mean CCT was 534 ± 72.3 µm (range: 430 to 610 µm). Mean IOP measurements were 15.1 ± 4.2 mmHg (range: 5.5 to 22.7 mmHg) for DCT and 14.5 ± 5.6 mmHg (range: 7.0 to 34.0 mmHg) for GAT (P = 0.244). Spearman correlation tests showed that IOP difference (DCT - GAT) was not correlated with CCT (r (2) = 0.023, P = 0.417). IOP measurements by DCT were weakly but statistically correlated with those obtained with GAT (r(2) = 0.213, P = 0.0089). Bland-Altman analysis revealed poor agreement between DCT and GAT readings, considering the 95 % confidence intervals of ± 10.45 mmHg. CONCLUSIONS: The differences between DCT and GAT readings were not influenced by CCT in this series of patients. Considering the weak correlation and the poor agreement observed between GAT and DCT measurements and that they both may be affected by corneal biomechanical changes, these methods should not be used interchangeably, and may possibly give no meaningful IOP values in PCG patients.

An eight-week, multicentric, randomized, interventional, open-label, phase 4, parallel comparison of the efficacy and tolerability of the fixed combination of timolol maleate 0.5%/brimonidine tartrate 0.2% versus fixed combination of timolol maleate 0.5%/dorzolamide 2% in patients with elevated intraocular pressure.

PURPOSE: To compare the efficacy and tolerability of the fixed combination of timolol maleate 0.5%/brimonidine tartrate 0.2% versus fixed combination of timolol maleate 0.5%/dorzolamide 2% in patients with elevated intraocular pressure (IOP) over 8 weeks. PATIENTS AND METHODS: This 8-week, multicentric, interventional, randomized, open-label, parallel group study was conducted at 4 centers in Brazil and 1 center in Argentina. Patients with open-angle glaucoma or ocular hypertension were randomized to receive bilaterally fixed combination of brimonidine/timolol maleate 0.5% or fixed combination of dorzolamide 2%/timolol 0.5% twice daily at 8:00 AM and 8:00 PM. A modified diurnal tension curve (8:00 AM, 10:30 AM, 02:00 PM, and 4:00 PM) followed by the water drinking test (WDT), which estimates IOP peak of diurnal tension curve, were performed in the baseline and week-8 visits. Adverse events data were recorded at each visit. RESULTS: A total of 210 patients were randomized (brimonidine/timolol, n=111; dorzolamide/timolol, n=99). Mean baseline IOP was 23.43+/-3.22 mm Hg and 23.43+/-4.06 mm Hg in the patients treated with brimonidine/timolol and dorzolamide/timolol, respectively (P=0.993). Mean diurnal IOP reduction after 8 weeks were 7.02+/-3.06 mm Hg and 6.91+/-3.67 mm Hg, respectively (P=0.811). The adjusted difference between groups (analysis of covariance) at week 8 was not statistically significant (P=0.847). Mean baseline WDT peak was 27.79+/-4.29 mm Hg in the brimonidine/timolol group and 27.68+/-5.46 mm Hg in the dorzolamide/timolol group. After 8 weeks of treatment, mean WDT peaks were 20.94+/-3.76 mm Hg (P<0.001) and 20.98+/-4.19 (P<0.001), respectively. The adjusted difference between groups (analysis of covariance) was not statistically significant (P=0.469). No statistical difference in terms of adverse events was found between groups. CONCLUSIONS: Both fixed combinations were capable of significantly reducing the mean diurnal IOP, mean diurnal peak, and mean WDT peak after 8 weeks of treatment. Also, both fixed combinations are well tolerated with few side effects.

Intraocular pressure fluctuations in response to the water-drinking provocative test in patients using latanoprost versus unoprostone.

Impairment of outflow facility in glaucoma causes large intraocular pressure (IOP) fluctuations that have been shown to be a risk factor for disease progression. The water-drinking provocative test (WDT) has been proposed as an indirect measurement of outflow facility to compare intraocular pressure responses of glaucoma eyes to different drugs. This study was a double-masked, randomized, parallel-group clinical trial comparing the IOP fluctuations in response to the WDT in patients using latanoprost versus unoprostone. After completing a wash-out of ocular hypotensive medications, patients with primary openangle glaucoma or ocular hypertension were randomized to receive either latanoprost (N=40) or unoprostone (N=42). IOP was measured before treatment and at 8 weeks after treatment (baseline IOP for WDT), followed by the WDT. IOP fluctuations and maximum IOP after water ingestion were compared between the two groups. Analysis of covariance was used to adjust for the effects of baseline IOP and treatment efficacy. The mean percentage reduction of IOP was 27% in patients using latanoprost, as compared to 13% in patients using unoprostone (p<0.001). Patients on treatment with latanoprost had significantly less IOP fluctuations in response to the WDT, compared to patients using unoprostone. From an overall baseline IOP of 20.0 mmHg and an overall treatment efficacy of 20%, the mean+/-standard error of the mean (SEM) of the IOP fluctuation during the WDT was 5.3+/-0.4 mmHg in the unoprostone group, and 3.6+/-0.4 mmHg in the latanoprost group (p=0.005, ANCOVA). This could represent an additional benefit of latanoprost over unoprostone in controlling the intraocular pressure of glaucomatous patients.