PURPOSE: To compare the intraocular pressure (IOP)-lowering effect and complication rate of nonpenetrating deep sclerectomy (NPDS) with reticulated hyaluronic acid (SK-GEL) scleral implant versus traditional punch trabeculectomy (PT) in the management of primary open angle glaucoma (POAG). METHODS: Prospective, randomized comparative study including 93 patients with uncontrolled POAG. Group 1 (43 eyes) underwent NPDS with SK-GEL scleral implant; Group 2 (50 eyes) underwent PT. Mitomycin C (0.2 mg/mL) was applied intraoperatively in both techniques. Study follow-up evaluations were conducted at 36 and 48 months. Complete success indicated the achievement of the target IOP without antiglaucoma medications, while qualified success indicated the same goal with medications. These categories were assessed at two target IOP levels, <21 mmHg and <18 mmHg. RESULTS: At 36 months for complete and qualified success with a <21 and <18 mmHg target IOP, no significant differences were noted between the two groups. At 48 months postprocedure when a <21 mmHg IOP target was considered, the rate of eyes that achieved complete success was 51.1% in the NPDS group versus 72% in the PT group (p<0.05). As for the <18 mmHg IOP target, the rate of eyes that achieved complete success was 32.5% in the NPDS group versus 44% in the PT group (p<0.05). Complications occurred significantly more frequently after PT than after NPDS. CONCLUSIONS: The IOP-lowering effects of the two procedures were comparable at 36 months. At 48 months PT showed a significantly higher rate of complete success compared with NPDS. Complications were more frequent after PT than after NPDS.
RCT Entities:
PURPOSE: To compare the intraocular pressure (IOP)-lowering effect and complication rate of nonpenetrating deep sclerectomy (NPDS) with reticulated hyaluronic acid (SK-GEL) scleral implant versus traditional punch trabeculectomy (PT) in the management of primary open angle glaucoma (POAG). METHODS: Prospective, randomized comparative study including 93 patients with uncontrolled POAG. Group 1 (43 eyes) underwent NPDS with SK-GEL scleral implant; Group 2 (50 eyes) underwent PT. Mitomycin C (0.2 mg/mL) was applied intraoperatively in both techniques. Study follow-up evaluations were conducted at 36 and 48 months. Complete success indicated the achievement of the target IOP without antiglaucoma medications, while qualified success indicated the same goal with medications. These categories were assessed at two target IOP levels, <21 mmHg and <18 mmHg. RESULTS: At 36 months for complete and qualified success with a <21 and <18 mmHg target IOP, no significant differences were noted between the two groups. At 48 months postprocedure when a <21 mmHg IOP target was considered, the rate of eyes that achieved complete success was 51.1% in the NPDS group versus 72% in the PT group (p<0.05). As for the <18 mmHg IOP target, the rate of eyes that achieved complete success was 32.5% in the NPDS group versus 44% in the PT group (p<0.05). Complications occurred significantly more frequently after PT than after NPDS. CONCLUSIONS: The IOP-lowering effects of the two procedures were comparable at 36 months. At 48 months PT showed a significantly higher rate of complete success compared with NPDS. Complications were more frequent after PT than after NPDS.