BACKGROUND: The purpose of our study was to assess intraocular pressure control (IOP) and postoperative complications in nonpenetrating very deep sclerectomy (NPVDS) with reticulated hyaluronic acid implant (SKGEL) and Mitomycin C (MMC). MATERIAL/ METHODS:Fifty eyes from fifty patients with medically uncontrolled glaucoma were randomized to either the NPVDS or NPDS group. The NPVDS procedure was similar to traditional NPDS (control group); however, excision of sclera and exposure of ciliary body were also performed, and only a narrow scleral flap was retained at a distance of 0.5 mm from Schlemm's canal. Mitomycin-C 0.2 mg/ml was applied on and under the superficial flap of the sclera during both NPVDS and NPDS. Follow-up examinations were carried out at 1 week, and then at 1, 3, 6, and 12 months after surgery. Success was defined as IOP <22 mmHg with or without glaucoma medication and laser procedures. RESULTS: The 12-month success rate in the NPVDS group was 96%, not significantly higher than in the control group (88%, p=0.88). There was no statistically significant difference in IOP between the NPVDS (15.9+/-2.5 mmHg) and NPDS (16.3+/-3.6 mmHg) groups (p=0.57). Complications included four cases of hyphema, three of choroidal detachment (myopic eyes), and one of filtering bleb fibrosis in the NPVDS group, and three cases of hyphema, two of choroidal detachment (myopic eyes), and three of filtering bleb fibrosis in the NPDS group. CONCLUSIONS:NPVDS is an effective surgical modality for patients with glaucoma. The safety of NPVDS is comparable to that of NPDS.
RCT Entities:
BACKGROUND: The purpose of our study was to assess intraocular pressure control (IOP) and postoperative complications in nonpenetrating very deep sclerectomy (NPVDS) with reticulated hyaluronic acid implant (SKGEL) and Mitomycin C (MMC). MATERIAL/ METHODS: Fifty eyes from fifty patients with medically uncontrolled glaucoma were randomized to either the NPVDS or NPDS group. The NPVDS procedure was similar to traditional NPDS (control group); however, excision of sclera and exposure of ciliary body were also performed, and only a narrow scleral flap was retained at a distance of 0.5 mm from Schlemm's canal. Mitomycin-C 0.2 mg/ml was applied on and under the superficial flap of the sclera during both NPVDS and NPDS. Follow-up examinations were carried out at 1 week, and then at 1, 3, 6, and 12 months after surgery. Success was defined as IOP <22 mmHg with or without glaucoma medication and laser procedures. RESULTS: The 12-month success rate in the NPVDS group was 96%, not significantly higher than in the control group (88%, p=0.88). There was no statistically significant difference in IOP between the NPVDS (15.9+/-2.5 mmHg) and NPDS (16.3+/-3.6 mmHg) groups (p=0.57). Complications included four cases of hyphema, three of choroidal detachment (myopic eyes), and one of filtering bleb fibrosis in the NPVDS group, and three cases of hyphema, two of choroidal detachment (myopic eyes), and three of filtering bleb fibrosis in the NPDS group. CONCLUSIONS: NPVDS is an effective surgical modality for patients with glaucoma. The safety of NPVDS is comparable to that of NPDS.