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.

treatments
Glaucoma

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

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A safe, minimally-invasive laser procedure
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Low post-operation complication rate
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Significant long-term reduction of IOP, stable over time
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Simple to perform with a short learning curve
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Reduces the need for medications
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Cost effective
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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.

CLASS: Novel Glaucoma Treatment

the IOPtiMate™, is a surgical system for treating  Glaucoma, which utilizes a CO2 laser technology in order to significantly reduce internal eye pressure (“IOP”), by restoring the natural fluid percolation without penetrating the eye.

CLASS: Novel Glaucoma Treatment

the IOPtiMate™, is a surgical system for treating  Glaucoma, which utilizes a CO2 laser technology in order to significantly reduce internal eye pressure (“IOP”), by restoring the natural fluid percolation without penetrating the eye.

CLASS: Novel Glaucoma Treatment

the IOPtimate™, is a surgical system for treating  Glaucoma, which utilizes a CO2 laser technology in order to significantly reduce internal eye pressure (“IOP”), by restoring the natural fluid percolation without penetrating the eye.

CLASS: Performed by Prof. Ehud Assia

Prof. Assia of Israel’s Meir Medical Center in Kfar Saba and creator of IOPtimateTM , maintains that the system transforms complex and highly risky surgery into a safe, elegant and precise laser-assisted procedure.

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: Performed by Prof. Andre Mermoud

For Prof. Mermoud of Swiss Clinique de Montchoisi in Lausanne, IOPtima’s CLASS procedure has real advantages over Trabeculectomy surgery, as it offers him an excellent, easy to use, safety profile .

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 

CLASS HP
CLASSHP
Clinical studies

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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

Indian Journal of Ophthalmology
25 Sep 2021
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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)

13 May 2021
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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

January 2021
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Retinal Nerve Fibre Layer Thickness Change After CO² Laser-Assisted Deep Sclerectomy Surgery

Zoltán Sohajda, Noémi Széll, Ágnes Revák, Júlia Papp, Edit Tóth-Molnár

Clinical Ophthalmology
July 2020
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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

J Glaucoma Volume 29, Number 5
May 2020
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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

October 2018
Journal of Glaucoma: - Volume 27 - Issue 10 - p 906-909
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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

J Clin Exp Opthamol, Volume 9 • Issue
5 September 2018
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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

Journal of Healthcare Engineering
May 2018
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SEE ALL CLINICAL STUDIES

What doctors say

Dr. Gangwei Cheng

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Dr. Gangwei Cheng

“Had some issues where my site crashed and broke, reached out to Fouroom to see if they could help me fix it. Even though we are 12 hours apart in time, they were quick to reply and willing to do what is needed to fix the issue.

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Dr. Gangwei Cheng

“Had some issues where my site crashed and broke, reached out to Fouroom to see if they could help me fix it. Even though we are 12 hours apart in time, they were quick to reply and willing to do what is needed to fix the issue.

Watch interview

Dr. Gangwei Cheng

“Had some issues where my site crashed and broke, reached out to Fouroom to see if they could help me fix it. Even though we are 12 hours apart in time, they were quick to reply and willing to do what is needed to fix the issue.

Watch interview

Prof. Zoltan Nagy

Semmelweis University, Budapest, Hungary

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Dr. Gangwei Cheng

Peking Union Medical College Hospital, China

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Dr. Juan Carlos Izquierdo

Oftalmo Salud Clinic, Lima, Peru

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Dr. Shlomo Melamed

Sheba Medical Center Tel Hashomer, Israel

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Dr. Shamira Perera

Singapore National Eye Center, Singapore

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