Surgeon Experience as a Risk Factor for Short-Term Failure for Ab Interno Gelatin Microstent: A Canadian Multicenter Propensity-Matched Study.

PURPOSE: To compare the efficacy and safety of early versus later ab interno gelatin microstent placement with mitomycin C. DESIGN: Canada-wide, multicenter, retrospective propensity score-matched cohort study. PARTICIPANTS: Two hundred seventy eyes (135 early cases and 135 later cases) with no prior incisional surgery. METHODS: Surgeons' first 20 patients (early cases group), from 6 glaucoma surgeons across 4 Canadian sites, were matched 1:1 to patients with the closest propensity score from the later (21+) patients (later cases group). MAIN OUTCOME MEASURES: Primary outcome was hazard ratio (HR) of failure of the early versus later cases groups, with failure defined as IOP of less than 6 mmHg with more than 2 lines of vision loss or more than 17 mmHg with no medications (complete success) on 2 consecutive visits despite in-clinic maneuvers (including needling) more than 1 month after surgery. Secondary outcomes were HRs for failure, defined as IOP outside the range of 6 to 14 mmHg and 6 to 21 mmHg with and without allowing for medications (qualified success), interventions, complications, and reoperations. RESULTS: Hazard ratio of failure for early versus later cases groups was 1.38 (95% confidence interval [CI], 0.97-1.96) for the IOP range of 6 to 17 mmHg, 1.29 (95% CI, 0.90-1.84) for 6 to 14 mmHg, and 1.48 (95% CI, 1.03-2.13) for 6 to 21 mmHg without medication and 0.95 (95% CI, 0.55-1.64), 0.95 (95% CI, 0.61-1.48), and 0.95 (95% CI, 0.52-1.75) for the same IOP ranges allowing for medications. Needling rates were 43.0% (early cases group) and 41.5% (later cases group). Complication rates after 1 month occurred in 9.6% (early cases group) and 11.1% (later cases group; P = 0.69). Reoperation rates were 14.8% (early cases group) and 8.1% (later cases group; P = 0.08). CONCLUSIONS: There is some evidence for improved success in the later cases group. Similar needling rates, similar complication rates, and a slightly higher reoperation rate were found for the early cases group. The results suggest that this procedure can be adopted by existing surgeons with current training regimens, although they may see an improvement in their success outcomes over time.

Prospective randomized comparison of one- versus two-site Phacotrabeculectomy two-year results.

PURPOSE: Previous studies have failed to find a significant difference in intraocular pressure (IOP) between one- and two-site phacotrabeculectomy. A possible explanation has been relatively small samples and short follow-up. We prospectively observed 80 patients for 2 years randomized to one- versus two-site phacotrabeculectomy with the primary outcome measure being IOP. DESIGN: Prospective randomized controlled study. PARTICIPANTS: Eighty eyes were randomized and 79 underwent phacotrabeculectomy; 76 completed 24 months' follow-up. METHODS: Eligible patients scheduled for phacotrabeculectomy were randomized to one- or two-site phacotrabeculectomy after giving informed consent. A sample size of 54 was calculated to detect a difference of 2 mmHg between the groups with a power of 80%. Data recorded included demographics, visual acuity, IOP, endothelial cell counts, glaucoma medications, phacoemulsification settings, iris manipulation, suture lysis, needling, and complications. Follow-up data were obtained at 3, 6, 12, and 24 months. MAIN OUTCOME MEASURE: Mean IOP at 24 months. RESULTS: There were no significant differences between the groups preoperatively. Mean IOPs were 17.6 versus 17.6, 12.6 versus 12.5, 13.1 versus 11.7, 13.1 versus 12.7, and 12.5 versus 12.9 mmHg for one- versus two-site at baseline and 3, 6, 12, and 24 months. There was a significant lowering of IOP compared with baseline at all time points (P<0.05). There was no significant difference in mean IOP between the groups at any time. The mean number of glaucoma medications decreased from 3.0 in each group to 0.2 and 0.4 for one- and two-site, respectively, at 24 months (P = 0.20). At 3 and 12 months, the endothelial counts (cells/mm(2)) were significantly lower in the two-site group: 2333 versus 2207 (P = 0.17), 2239 versus 1938 (P = 0.01), 2180 versus 1934 (P = 0.04), and 2147 versus 1947 (P = 0.08) at baseline and 3, 12, and 24 months, respectively. The surgical time was significantly longer for two-site (48.1+/-7.8 minutes) compared with one-site (39.2+/-6.4 minutes; P<0.001). CONCLUSION: At 2 years after phacotrabeculectomy, there was no statistically significant difference in IOP between groups. Corneal endothelial cell counts were significantly lower in the two-site group at 3 and 12 months. Two-site surgery took significantly more time.

Clinical results with the Trabectome, a novel surgical device for treatment of open-angle glaucoma.

PURPOSE: To describe treatment outcomes after Trabectome surgery in an initial series of 101 patients with open-angle glaucoma. METHODS: A 19-gauge microelectrosurgical device enabled ab interno removal of a strip of trabecular meshwork and inner wall of Schlemm's canal under gonioscopic control with continual infusion and foot-pedal control of aspiration and electrosurgery. A smooth, pointed ceramic-coated insulating footplate was inserted into Schlemm's canal to act as a guide within the canal and to protect adjacent structures from mechanical or heat injury during ablation of a 30- to 90-degree arc of angle tissue. RESULTS: Mean preoperative intraocular pressure (IOP) in the initial 101 patients was 27.6 +/- 7.2 mm Hg. Thirty months postoperatively, mean IOP was 16.3 +/- 3.3 mm Hg (n = 11). The mean percentage drop over the whole course of follow-up was 40%. At all times postoperatively, the absolute and percent decrease in IOP from preoperative levels were statistically significant (paired t test, P < .0001). Overall success (IOP