Abstract
Purpose: :
To evaluate the efficacy of CO2 Laser Assisted Sclerectomy Surgery (CLASS) in primary and pseudoexfoliative open-angle glaucoma (OAG).
Methods: :
A prospective, multi-center, multi-national clinical study. Candidates for primary filtration surgery underwent CLASS with a CO2 laser system (OT-134-"IOPtiMate", IOPtima Ltd., Ramat Gan, Israel). The system gradually ablates and removes scleral layers until percolating fluid absorbs the energy, attenuating further tissue ablation. Intraocular pressure (IOP) was measured at baseline, 1, 2, 4 and 6 weeks, and 3, 6, 12 and 24 months. Complete success was defined as 5≤ IOP≤ 18 mmHg and 20% IOP reduction with no medications, and qualified success as the same IOP range with or without medications.
Results: :
62 subjects with OAG underwent the procedure in 5 sites. 47 and 16 completed 12 and 24 months of follow-up by the time of writing this abstract. Mitomycin C was used in 50 procedures (80.6%). The mean baseline IOP of 25.2 ± 6.01 mmHg (mean ±SD) dropped to 13.4 ± 3.32 and 14.6 ± 2.83 mmHg at 12 and 24 months, respectively, with 47.5 % and 42.7 % reduction at 12 and 24 months, respectively (P<0.001). Complete success was achieved by 71.1% and 62.5% of the subjects at 12 and 24 months, respectively, whereas qualified success was achieved by 88.8% and 81.2%. Average number of medications dropped from 2.0 to 0.25 at 24 months. Complications were mild and transitory with no sequela.
Conclusions: :
Short and intermediate term results suggest that CLASS may become simple, safe and effective means of choice for OAG treatment.
Clinical Trial: :
NIH, NA
Keywords: laser • intraocular pressure