Three-year Study Shows Significant Advantages of CLASS (CO 2 Laser Assisted Sclerectomy Surgery)
for Patients with Glaucoma
Safe and effective procedure offers long-term pressure reduction, low complication rate
TEL AVIV – December 12, 2016 – IOPtima Ltd., a developer of laser-assisted and other innovative surgical ophthalmic devices, today announced the publication of 3-year follow up data from a multi-center study of patients undergoing CLASS (CO 2 Laser Assisted Sclerectomy Surgery) with IOPtima’s IOPtiMate™ CO 2 laser system for treatment of primary open-angle glaucoma or pseudoexfoliative glaucoma. The study evaluated 111 consecutive eyes of 111 participants and demonstrated a decrease in IOP from baseline at 1, 2 and 3 years of 45.1%, 46.8% and 42.5% (P< 0.001), respectively. Patients also used significantly fewer medications after surgery.
“Using IOPtiMate for the CLASS procedure, we found that the eye was normally quiet, and vision was maintained soon after surgery. The procedure is easy for surgeons to learn. The fluid percolation is titrated during surgery; we continue laser applications until we achieve a satisfactory clinical result,” said Ehud Assia, MD, of the IOPtiMate study’s prime site, Meir Medical Center in Kfar Saba, Israel.
According to Andre Mermoud, MD, of Clinique de Montchoisi in Lausanne, Switzerland, who followed 15 patients in the study, “IOPtima’s CLASS procedure has true advantages over trabeculectomy surgery, particularly its excellent safety profile and ease of use. It can reduce pressure to the low teens and reduce patients’ reliance on glaucoma medications without subjecting the eye to the risks of trabeculectomy. It also reduces learning curve time for performing deep sclerectomy with very similar results to published data.”
The multi-center study was carried out in nine medical centers on four continents, including centers in Mexico City; Madanapalle, India; Moscow; Ancona, Italy; Valencia, Spain; Geneva; Lausanne, Switzerland; Tel Aviv and Kfar Saba, Israel. The studies were conducted in accordance with the Declaration of Helsinki with the approval of the Human Research Committee of the participating medical centers with applicable regulations pertaining to Good Clinical Practice.
Between December 2007 and February 2011, 111 consecutive eyes of 111 subjects were enrolled in the study. Inclusion criteria were uncontrolled glaucoma under maximally tolerated hypotensive medical treatment, with a baseline IOP higher than 18 mmHg and no other ocular surgery or laser treatment, except prior clear corneal incision cataract surgery. Exclusion criteria were previous ocular surgery (other than cataract), ocular media opacity preventing proper evaluation of the optic nerve, extremely small pupil size and poor vision in the fellow eye. Complete success was defined as 20% IOP reduction and IOP between 5 and 18 mmHg. Similar IOP requirements achieved with hypotensive medications were defined as qualified success.
Three-year primary findings of the study included:
Low complication rate: Complications were reduced more than 35% compared to trabeculectomy (based on treatment outcomes in the Tube Versus Trabeculectomy (TVT) study 1 ). 1 Gedde SJ, Schiffman JC, Feuer WJ, et al. Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. Am J Ophthalmol. 2012 May; 153:789–803.
High and consistent success rates: Complete success rates after 12, 24 and 36 months were 60.2%, 57.9% and 47.8%, respectively. Qualified success rates after 12, 24 and 36 months were 79.6%, 91.2% and 84.8%, respectively.
Significant IOP reduction that was also controlled over time: The preoperative IOP of 25.8±5.4 mm Hg (mean± SD) dropped to 13.5±3.8, 13.5±4.1, 13.0±3.1 and 14.2±2.9 mm Hg at 6, 12, 24 and 36 months, respectively.
Significant medication reduction: Number of medications dropped from 2.39±1.24 to 0.47±0.84, 0.53±0.75 and 0.71±0.89 at 12, 24 and 36 months, respectively.
No technical device malfunctions occurred during the study in any of the sites.
Surgeons experienced a high comfort level, simple procedure and short learning curve.
The paper has been published in the December, 2016 issue of Journal of Glaucoma and is available online to subscribers. The authors are Noa Geffen, MD, Michael Mimouni, MD, Mark Sherwood, MD, and Ehud I. Assia, MD.
About IOPtima’s CLASS with the IOPtiMate™ System
With a mission to address the unmet needs and common safety problems in glaucoma surgery, IOPtima has developed a procedure called CLASS (CO 2 Laser-Assisted Sclerectomy Surgery). This elegant, self-regulated procedure performed using the IOPtiMate™ system, designed to achieve optimal functional, results from surgery. The simple, safe reproducible procedure results in minimal side effects and reduced recovery time.
About IOPtima Ltd.
Established in 2005, IOPtima Ltd., a Bio-Light company (BOLT:TASE), is a developer of laser-assisted surgical ophthalmic devices and additional innovative products for ophthalmic surgeries. The company’s flagship product, the IOPtiMate™, is a surgical system for the treatment of glaucoma. It utilizes CO 2 laser technology to significantly reduce intraocular pressure (IOP) by restoring the natural fluid percolation without penetrating the eye. For more information about IOPtima, please visit the company’s website: www.IOPtima.co.il