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CO2 Laser-assisted Sclerectomy Surgery Part I: Concept and Experimental Models (http://www.ncbi.nlm.nih.gov/pubmed/21423033)
To be published in the 21:2 edition of J Glaucoma (FEB 2012).
Source
Departments of *Ophthalmology †Pathology, Meir Medical Center, Kfar Saba, and the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv ‡CEO of IOPtima Ltd, Ramat-Gan, Israel.
Abstract
PURPOSE:
To evaluate the safety and performance of a second-generation device for CO2 laser-assisted sclerectomy surgery system in experimental models.
MATERIALS AND METHODS:
Laser-assisted deep sclerectomy using a modified CO2 laser system (OT-134-"IOPtiMate"; IOPtima Ltd, Israel) was performed in 3 experimental models: enucleated pig eyes, human cadaver eyes, and live rabbit eyes. A half-thickness scleral flap was created, and a CO2 laser with a beam-manipulating system was used to achieve deep scleral ablation over the Schlemm canal zone. Aqueous percolation and scleral perforation rates were recorded. Intraocular pressure was monitored in live rabbits up to 21 days postoperatively. The shape and location of the scleral ablation zone, thermal damage, and the healing process were examined by histopathological analysis.
RESULTS:
Deep scleral ablation and aqueous percolation were repeatedly achieved in all the models. Micro-perforations occurred in 4/18 human eyes (22.2%), in 4/23 rabbit eyes (17.4%), and in none of the 38 porcine eyes. Mean intraocular pressure in the rabbits was significantly decreased (by 6.3±3.6 mm Hg) on the first postoperative day (P<0.0001) and gradually returned to normal. In all but one of the cadaver eyes, effective fluid percolation was achieved. Histology in each case disclosed deep scleral craters with a thin intact sclero-corneal tissue layer at the ablation area. Mild thermal damage, limited to the ablated scleral walls was detected and resolved after 10 days.
CONCLUSIONS:
The results in these experimental studies indicated that CO2 laser-assisted sclerectomy surgery using the OT-134 system is a safe and efficacious procedure for achieving effective fluid percolation.
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CO2 Laser-assisted Sclerectomy Surgery, Part II: Multicenter Clinical Preliminary Study (http://www.ncbi.nlm.nih.gov/pubmed/21173710)
To be published in the 21:3 edition of J Glaucoma (MAR 2012).
Geffen N, Ton Y, Degani J, Assia EI.
Source
*Department of Ophthalmology, Meir Medical Center, Kfar Saba †Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv ‡IOPtima Ltd, Ramat-Gan, Israel.
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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