CO: Multicenter Clinical Preliminary Study2: Multicenter Clinical Preliminary Study Laser-assisted Sclerectomy Surgery, Part II: Multicenter Clinical Preliminary Study

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Abstract

Purpose

To evaluate the efficacy of CO2 laser-assisted sclerectomy surgery (CLASS) in primary and pseudoexfoliative open-angle glaucoma.

Materials and Methods

Patients for primary filtration surgery underwent CLASS with a CO2 laser system (OT-134-IOPtiMate, IOPtima Ltd., Ramat Gan, Israel). This self-controlled 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, and 12 months, respectively. Complete success was defined as 5≤IOP≤18 mm Hg and 20% IOP reduction with no medication at a 12-month endpoint visit, and qualified success as the same IOP range with or without medication.

Results

Thirty of 37 patients completed 12 months of follow-up. Mitomycin C was used in 25 procedures (83.3%). The mean baseline IOP of 26.3±7.8 mm Hg (mean±SD) dropped to 14.4±3.4 and 14.3±3.1 mm Hg at 6 and 12 months, respectively, with 42.4% and 40.7% IOP reduction at 6 and 12 months, respectively (P<0.001). Complete success was achieved by 76.7% and 60% of the patients at 6 and 12 months, respectively, whereas qualified success was achieved by 83.3% and 86.6% of the patients at 6 and 12 months, respectively. Complications were mild and transitory with no sequela.

Conclusions

Short-term and intermediate results suggest that CLASS may become a simple, safe, and effective means of choice for the treatment of open-angle glaucoma.

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