PURPOSE: To evaluate the safety and efficacy of CO2 laser-assisted deep sclerectomy surgery (CLASS) in patients with open angle glaucoma. DESIGN: A prospective single-arm, nonrandomized clinical investigation for the evaluation of technology. METHODS: Fifteen eyes of 15 consecutive patients diagnosed with either primary open angle glaucoma or pseudoexfoliation glaucoma who were the candidates for glaucoma filtration surgery were included. Laser-assisted deep sclerectomy using a CO2 laser system was performed in all patients. A half-thickness scleral flap was created, the use of 0.04% mitomycin C for 60 seconds was left at the surgeon's discretion, and a CO2 laser with a beam-manipulating system was used to achieve deep scleral ablation and unroofing of Schlemm's canal zone. Visual acuity, complete ophthalmologic examination, and intraocular pressure (IOP) were measured and documented at baseline, 1, 2, 4, and 6 weeks and at 3, 6, and 12 months, respectively. Complete success was defined as 5≤IOP≤21 mm Hg and 20% IOP reduction with no medication at the 12-month endpoint visit. Qualified success was defined as a similar IOP reduction with medication. RESULTS: The preoperative IOP of 27.3±4.2 mm Hg (mean±SD) dropped to 15.0±3.7 mm Hg at 6 months and 16.6±3.4 mm Hg at 12 months postoperatively, yielding an average IOP reductions at 6 and 12 months of 13.1±4.3 mm Hg (45.1%; 95% CI, 11, 15.3) and 11.5±5.5 mm Hg (39.2%; 95% CI, 8.8, 14.3), respectively (P<0.001). The complete success rate after 12 months was 45.5%, whereas qualified success was 90.9%. Mitomycin C was used in 76.9% of the CLASS subjects.
PURPOSE: To evaluate the safety and efficacy of CO2 laser-assisted deep sclerectomy surgery (CLASS) in patients with open angle glaucoma. DESIGN: A prospective single-arm, nonrandomized clinical investigation for the evaluation of technology. METHODS: Fifteen eyes of 15 consecutive patients diagnosed with either primary open angle glaucoma or pseudoexfoliation glaucoma who were the candidates for glaucoma filtration surgery were included. Laser-assisted deep sclerectomy using a CO2 laser system was performed in all patients. A half-thickness scleral flap was created, the use of 0.04% mitomycin C for 60 seconds was left at the surgeon's discretion, and a CO2 laser with a beam-manipulating system was used to achieve deep scleral ablation and unroofing of Schlemm's canal zone. Visual acuity, complete ophthalmologic examination, and intraocular pressure (IOP) were measured and documented at baseline, 1, 2, 4, and 6 weeks and at 3, 6, and 12 months, respectively. Complete success was defined as 5≤IOP≤21 mm Hg and 20% IOP reduction with no medication at the 12-month endpoint visit. Qualified success was defined as a similar IOP reduction with medication. RESULTS: The preoperative IOP of 27.3±4.2 mm Hg (mean±SD) dropped to 15.0±3.7 mm Hg at 6 months and 16.6±3.4 mm Hg at 12 months postoperatively, yielding an average IOP reductions at 6 and 12 months of 13.1±4.3 mm Hg (45.1%; 95% CI, 11, 15.3) and 11.5±5.5 mm Hg (39.2%; 95% CI, 8.8, 14.3), respectively (P<0.001). The complete success rate after 12 months was 45.5%, whereas qualified success was 90.9%. Mitomycin C was used in 76.9% of the CLASS subjects.