IOPtimate®
CO2 Laser-Assisted Sclerectomy System for Advanced and End-Stage Glaucoma
The IOPtimate® laser-based surgical system utilizes CO2 laser technology for advanced and end-stage glaucoma patients.
Precision and simplicity
The IOPtimate®, combined with the carbon dioxide (CO2) laser, allows surgeons full control of treatment parameters, including shape, power, and depth of ablation to optimize the surgery and minimize unnecessary tissue damage.
When used for glaucoma surgery, stand-alone or combined with cataract, the IOPtimate® offers a standardized and simple way to perform deep sclerectomy surgery, named CLASS (Co2 Laser Assisted Sclerectomy Surgery), to reduce internal eye pressure (IOP).
During CLASS procedures, the surgeon thins the scleral wall with precise ablations to the normal eye drainage area (Schlemm’s canal region) by gradually removing most of the scleral tissue, layer by layer, until sufficient percolation is achieved.
Since CO2 laser radiation is absorbed and blocked by aqueous humor, laser energy is prevented from penetrating the eye, leaving a thin scleral layer intact and reducing the likelihood of surgical complications, perilous incidents, or side effects.
CLASS* procedure
*CLASS: CO2 Laser-Assisted Sclerectomy Surgery
1
Anesthesia administration and downwards tilt of the eye. Conjunctiva flap creation with fornix-based method. Scleral flap creation (5.0 x 5.0 mm) into clear cornea (1/3to 1/2 of sclera thickness)
2
Creation of scleral reservoir using the laser and application of Mitomycin C
3
Positioning of a pre-selected pattern on the limbus line for rapid scanning and ablation of the thin scleral layers, until unroofing of the Schlemm’s Canal
4
Fluid percolation beginning through intact trabecular meshwork. Continuing of ablation until sufficient percolation is achieved
5
The percolation fluid absorbs laser energy, self-regulating eye penetration and increasing safety
6
Closing and suturing of sclera flap and the conjunctiva
CLASS advantages
Unlike other surgical solutions, the CLASS procedure is non-penetrating and does not involve the presence of foreign bodies in the eye.
A 5-year clinical study of the IOPtiMate® demonstrates a significantly reduced complication rate in comparison with other surgical solutions currently in the market.
Clinical study results show a reduction in IOP over the years of over 40%.
The regulated laser scan procedure makes CLASS appealing for less experienced surgeons as well.
Clinical study results show significant reduction or elimination of medication requirements post-surgery.
CLASS’s flexible business model fits both private and public hospitals and clinics.
CLASS vs other surgical alternatives
Advantages over trabeculectomy & non-penetrating procedures
CLASS technology is easy to use and provides surgeons with enhanced control of the procedure through laser-scanning. This leads to predictive outcomes and high reproducibility, unlike NPDS which requires high technical skills and a long learning curve.
CLASS is a non-penetrating and highly regulated procedure, providing an exceptional safety profile with a lower number of complications and reduced postoperative care requirements when compared to penetrating trabeculectomy procedures.
Advantages over other alternatives (MIGS, GDDs, Shunts)
CLASS does not leave any foreign bodies in the eye, eliminating a major risk for various complications such as scarring, migration and hyphemia.
Numerous publications have demonstrated CLASS’s high efficacy with clinical results of around 40% reduction in IOP over the years and a significant reduction in medication requirements. Contrarily, MIGS devices are usually associated with limited efficacy.
Live surgeries
CLASS Learning Curve by Dr. Cosme Lavin Dapena
Dr Cosme Lavin-Dapena compares, in this video, CLASS and NPDS procedures and learning curve. NPDS has emerged gradually as the reference in the surgery of open angle glaucoma. Control of IOP and low rate of post-operative complications, but this surgery is difficult and requires a long learning curve.
A case of CO² laser assisted sclerotomy on a failed Xen45 patient: Performed by Dr. Mario Riquelme
CLASS (CO2 Laser-Assisted Sclerectomy Surgery) can also be beneficial following a failed XEN. Pre-op (CLASS) IOP was 33 mmHg on cosopt + Lumigan + Acetazolamide tab 250 mg x 3 / day. At 2 year follow up, the IOP was 13 mmHg under cosopt X2 / day. A prolene 6-0 spacer was used over sclerotomy and reservoir area that facilitates the drainage of the aqueous humor.
Combined CLASS PHACO with suprachoroidal esnoper implant: Performed by Dr. Nir Shoham-Hazon
The ESNOPER scleral implant is indicated for non-penetrating deep sclerectomy (NPDS) and thus far for CO2 Laser Assisted Sclerectomy Surgery (CLASS) in open-angle glaucoma surgery. The ESNOPER scleral implant, is a non-reabsorbable implant that provides a fixed, permanent intrascleral space, that facilitates the drainage of aqueous humor.
CLASS: Perfomed by Dr. Nir Shoham-Hazon
Dr. Nir Shoham Hazon of Israel’s Barzilai Medical Center in Ashkelon, describes the steps taken during a novel, non-penetrating treatment of CO2 laser-assisted sclerectomy surgery, utilizing the IOPtiMate™ system. “CLASS has proven to be a safe and simple procedure to perform, with the potential of becoming the first line of surgery”.
Combined CLASS and Phaco: Performed Dr. Nir Shoham-Hazon
Similar to Trabeculectomy, CLASS can be performed in combination with a phacoemulsification procedure. The combined procedure allows anterior segment surgeons to also be able to provide their patient with a safe and effective Glaucoma surgery option.
CLASS in Pseudophakic Eye: Performed by Prof. Edward Wylegala
Prof. Wylegala of Poland’s Medical University of Silesia in Katowice and Poland’s School of Medicine with the Division of Dentistry in Zabrze, claims that CO2 Laser Assisted Sclerectomy Surgery (CLASS), is a unique microinvasive surgical procedure that reduces IOP in open angle glaucoma patients, with a low postoperative complication rate.
Acessory
The CLASSHP laser handpiece is an easy and ergonomic plug-and-play approach to perform CO2 Laser-Assisted Sclerectomy Surgery (CLASS).
The CLASSHP allows highly controlled laser-ablations of scleral tissue layer by layer, until exposure of Schlemm’s canal. Laser ablations are controlled via a footswitch.
Exp. launch date – June 2022
Retrospective analysis of the comparison between carbon dioxide laser-assisted deep sclerectomy combined with phacoemulsification and conventional trabeculectomy with phacoemulsification
Vidya Raja S, Arvin Kurian Ponnat, Balagiri K, Srilekha Pallamparthy
Surgical Outcomes of Modified CO2 Laser-assisted Sclerectomy for Uveitic Glaucoma, Ocular Immunology and Inflammation
Junyan Xiao, Chan Zhao, Yang Zhang, Anyi Liang, Yi Qu, Gangwei Cheng & Meifen Zhang (May 2021)
Evaluating CLASS surgery with mitomycin C combined with or without phacoemulsification in adult Asian glaucoma subjects.
Dawn Ching Wen Ho . Shamira A. Perera . Myint Htoon Hla. Ching Lin Hoy
Retinal Nerve Fibre Layer Thickness Change After CO² Laser-Assisted Deep Sclerectomy Surgery
Zoltán Sohajda, Noémi Széll, Ágnes Revák, Júlia Papp, Edit Tóth-Molnár
Modified CO2 Laser-Assisted Sclerectomy Surgery in Chinese Patients with Primary Open-Angle Glaucoma and Pseudoexfoliative Glaucoma
A Two-year Follow-up Study Zhang, Yang MD; Cheng, Gangwei MD
CO2 Laser-assisted Deep Sclerectomy Combined With Phacoemulsification in Patients With Primary Open-angle Glaucoma and Cataract.
Yu, Xiaojiao MD; Chen, Chunlin MD; Sun, Min MD; Dong, Denghao MD; Zhang, Shuoji PhD; Liu, Pei PhD; Yuan, Rongdi MD; Ye, Jian MD
Comparative Clinical Results of Phacoemulsification Combined with CLASS vs. Phaco Combined with Trabeculectomy in Patients with Open-Angle Glaucoma.
Juan Carlos Izquierdo Villavicencio, Fabiola Patricia Quezada Baltodano, Imelda María Ramírez Jiménez, Ana Luisa González Méndez and María Corina Ponte-Dávila
The CLASS Surgical Site Characteristics in a Clinical Grading Scale and Anterior Segment Optical Coherence Tomography: A One-Year Follow-Up.
Judyta Jankowska-Szmul and Edward Wylegala
Surgical Innovations in Glaucoma
CO2 Laser-Assisted Deep Sclerectomy Surgery in Samples, John R. Surgical Innovations inGlaucoma. Ed. Iqbal Ike K. Ahmed. Springer 2014, vol XI pp 104-106.
Glaucoma Surgery
Laser-Assisted Techniques for Penetrating and Non-Penetrating Glaucoma Surgery in BettinP, Khaw PT (eds): Glaucoma Surgery. Developments in Ophthalmology. Basel, Karger, 2012,vol 50, pp 96–108.
What doctors say
Prof. Zoltan Nagy
Semmelweis University, Budapest, Hungary
Dr. Gangwei Cheng
Peking Union Medical College Hospital, China
Dr. Juan Carlos Izquierdo
Oftalmo Salud Clinic, Lima, Peru
Dr. Shlomo Melamed
Sheba Medical Center Tel Hashomer, Israel
Dr. Shamira Perera
Singapore National Eye Center, Singapore