Intraocular pressure control after combined phacotrabeculectomy versus trabeculectomy alone.

PURPOSE: We compared the efficacy and safety of trabeculectomy and phacotrabeculectomy in patients with glaucoma. MATERIALS AND METHODS: We retrospectively analyzed consecutive patients who underwent trabeculectomy or phacotrabeculectomy. Patients in the trabeculectomy group were pseudophakic. We established three different intraocular pressure (IOP) thresholds (A: <21 mmHg, B: <18 mmHg, and C: <15 mmHg) to measure complete (without medication) and qualified (with medication) success. Success criteria were analyzed through Kaplan-Meier survival curves. RESULTS: Sixty-seven eyes were included (40 trabeculectomy, 27 phacotrabeculectomy). The mean follow-up period was 25.70 ± 14.439 months. The baseline characteristics were similar between the groups. The complete and qualified success rates according to criterion C were significantly higher in the trabeculectomy group (p = 0.033, p = 0.021, respectively); however, there was a trend toward a higher success rate for all criteria in favor of trabeculectomy. Bleb needling was more frequent in the phacotrabeculectomy group. The mean IOP significantly decreased from 26.46 ± 7.07 to 12.27 ± 4.06 at 12 months (p < 0.001). The final mean IOP was significantly lower in the trabeculectomy than in the phacotrabeculectomy group (10.95 ± 3.08 vs 13.00 ± 4.56, p = 0.0003). CONCLUSION: In pseudophakic eyes, trabeculectomy alone achieves a higher success rate, lower mean IOP, and less frequent bleb needlings. More frequent follow-up and prolonged postoperative use of high-dose topical steroids should be considered in patients undergoing phacotrabeculectomy.

Endothelial Cell Density After XEN Implant Surgery: Short-term Data From the Italian XEN Glaucoma Treatment Registry (XEN-GTR).

PRECIS: XEN implant was associated with low endothelial cell density (ECD) reduction. In fact, when combined with phacoemulsification, the reduction in ECD was similar to that expected after phacoemulsification alone. PURPOSE: The purpose of this study was to assess the impact of XEN implant, either alone or in combination with phacoemulsification, on ECD. METHODS: Multicenter, prospective, observational study conducted on consecutive open-angle glaucoma patients, who were enrolled in the Italian XEN Glaucoma Treatment Registry and have complete endothelial cell count data at baseline and at 6 months after implantation. The primary endpoint was the mean percentage change in ECD between baseline and month 6. RESULTS: The study included 108 open-angle glaucoma eyes (68 in the XEN-solo and 40 eyes in the XEN+phaco groups) and 60 control eyes (phaco-solo group). As compared with baseline, mean (95% confidence interval, CI) ECD reduction was -5.6% (-7.0% to -4.9%), -11.3% (-13.8% to -10.9%), and -13.0% (14.8% to -11.8%) in the XEN-solo, XEN+phaco, and phaco-solo groups, respectively (P=0.0004, <0.0001, and <0.0001, respectively). As compared with the XEN-solo group, the ECD reduction was significantly greater in the XEN+phaco group (mean difference=5.7%; 95% CI: 4.1%-7.3%, P<0.0001) and in the phaco-solo group (mean difference=7.4%; 95% CI: 5.7%-9.1%, P<0.0001). ECD reduction was similar in XEN+phaco and phaco-solo groups (P=0.9). In absolute terms, ECD reduction was significantly greater in the XEN+phaco (mean difference=169±306, P=0.021) and in the phaco-solo (mean difference=192±302, P=0.0022) groups than in the XEN-solo group. CONCLUSIONS: The mean ECD reduction 6 months after XEN implantation was low. The ECD reduction in the XEN+phaco group was larger than in the XEN-solo group but was similar to that observed in the phaco-solo group.

Medical management of pediatric glaucoma: lessons learned from randomized clinical trials.

PURPOSE: To critically discuss the randomized clinical trials (RCTs) on glaucoma medical therapy for the management of pediatric glaucoma. METHODS: RCTs on glaucoma drugs carried out on pediatric subjects with ocular hypertension and glaucoma were identified through systematic searches. The methods of the RCTs and the safety and the efficacy of the glaucoma drugs were reviewed and discussed. RESULTS: We included five RCTs. One study compared dorzolamide with 0.5% timolol gel; one brinzolamide with 0.5% levobetaxolol; one 0.25% betaxolol, 0.25% timolol gel, and 0.5% timolol gel; one latanoprost with 0.5% timolol; and one travoprost with 0.5% timolol. The primary outcome was safety for two studies and efficacy for three studies. None of the RCTs was powered to detect statistically significant differences in intraocular pressure (IOP) between treatments. In total, 658 subjects received at least one dose of study medication. Beta-blockers were administered to 359 patients, carbonic anhydrase inhibitor (CAI) to 154, and prostaglandins to 145 patients. IOP-lowering efficacy ranged from 20 to 23% for CAI, from 9 to 36% for beta-blockers, and from 26 to 27% for prostaglandins. The percentage of responders was 50% for CAI, ranged from 38 to 74% for beta-blockers and from 60 to 83% for prostaglandins. Two patients receiving timolol experienced a systemic, drug-related serious adverse event (one patient bradycardia and one pneumonia). Systemic, nonserious drug-related events occurred in 15 patients randomized to beta-blockers and in 8 patients randomized to CAI. No adverse events occurred in children treated with prostaglandins. CONCLUSION: RCTs that are available on medical therapy for glaucoma are few and underpowered. The proportion of responders is lower in children; however, in subjects who are responders, the efficacy of glaucoma drugs seemed to be comparable to that in adults. As systemic adverse events have been reported, including serious events with timolol, a particular attempt to minimize the absorption of the drug (using the lowest dose and the gel formulation of beta-blockers or considering the lacrimal punctum occlusion) and a follow-up that is more frequent and more focused on safety should be considered in pediatric subjects who are on topical glaucoma medications.