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Glaucoma is a group of eye disorders characterized by the progressive loss of nerve tissue, often leading to blindness. It is the second leading cause of vision loss in the world,  affecting an estimated 68 million people globally, with over 5 million in the United States and 12 million in Europe. As is the case with most eye diseases, the elderly are most likely to be affected by Glaucoma with the incidence of the disease growing as patients’ age advances.

Glaucoma is caused by an increased pressure(IOP) in the eye, as a result of intraocular fluid (also known as aqueous humor) flow blockage. Such blockage of aqueous humor flow, leads to increase pressure that, when left untreated, can result in vision impairment.

The disease is often called “the silent thief of sight”, due to the fact that most patients experience no symptoms at all. Sometimes patients do not realize they have the disease until damage had become irreversible.

Treatment Methods

It has been previously demonstrated that the most effective way of preventing Glaucoma damage, is to reduce IOP. Reducing the IOP improves blood flow to the nerve tissue  consequently slowing down or halting progression in nerve damage. Therefore, the primary goal of treatment is reducing elevated intraocular pressure.

Current treatments for Open-Angle Glaucoma (OAG) include medications, Laser Trabeculoplasty, and a variety of surgical solutions. Treatment will depend on the progression of the disease, as well as both the patient’s endurance of the therapy and its efficacy in reducing IOP.

Medicinal treatment is often considered the first course of action. Given the complexity of regimens, the chronic use of multiple medications, daily administration requirements, the absence of a beneficial effect that can be observed by the patient and the side effects. Other considerations include patients not adhering to medical orders and not taking their medication consistently. When medicine is no longer effective, many physicians will incorporate Laser Trabeculoplasty. However, it has not been able to demonstrate a long-term reduction of IOP. Once all the above proves unsuccessful, the standard course of treatment is  a surgical procedure to increase the drainage.

CLASS procedure is just one of the surgical alternatives for treating Glaucoma. The high safety profile of CLASS and its proven efficacy makes it a popular choice for surgeons and patient alike.

Your physician will design a treatment regimen best suitable for your condition, based on efficacy, safety and tolerability.

IOPtima's solution

IOPtima CO2 Laser-Assisted Sclerectomy Surgery (CLASS)

IOPtima  developed the IOPtiMateTM system, a unique, minimally invasive CO2 laser-assisted system for treating Glaucoma.

Utilizing the particular properties of the CO2 laser, the CLASS works to thin the white part of the eye (the sclera wall) by ablative surges to the natural drainage area (the Schlemm’s Canal), without penetrating  the eye. The CO2 laser permits the adequate, functional percolation of intra-ocular fluid from the eye through the remaining membrane in a simple, highly controlled targeted manner.

As infrared CO2 laser radiation is absorbed and blocked by water and aqueous solutions, its ablating capabilities are rendered ineffective when applied over wet tissues. Therefore, unlike other invasive procedures, the CLASS does not allow for the penetration of the eye.

Following the CLASS procedure, the remaining thin scleral layer remains intact, without penetration into the eye, without needing to insert foreign bodies to the eye, known to be the source of most ophthalmic surgery complications, perilous incidents or side effects.

Clinical Evidence and Experience of the CLASS procedure

A multi-center clinical study was performed on 111 patients in 9 global sites (Switzerland, Spain, Italy, Israel, Russia, India and Mexico). Three-year follow up data consistently demonstrated tremendous efficacy in IOP reduction, as well as drastic decline in medication admission. Data also revealed a surging safety profile due to the significant reduction of intra-operative risk and postoperative complications.

The IOPtimate system utilized for the CLASS procedure has obtained regulatory approval in Europe (CE Mark), China (CFDA), Israel (AMAR) and Mexico (Cofepris).

CLASS is available in various major medical centers throughout the world, with over 6500 CLASS procedures performed to date.

The Advantage of performing the CLASS procedure

Unlike other surgical solutions, the CLASS procedure is non-penetrating and doesn’t involve foreign bodies

A clinical study  of CLASS procedure with a 3-year follow up period shows significantly reduced complication rates in comparison with other current surgical solutions

Clinical study results show over 40% reduction in IOP over the years

Clinical study results show significant reduction or elimination of medication consumption post procedure

Procedure Steps

Step 1

Step 1

Creation of scleral flap
 
Step 2

Step 2

Laser ablation for thinning the sclera up to exposure of the drainage area (Schlemm’s canal)
 
Step 3

Step 3

Laser beam stops once percolation of fluid is achieved
Step 4

Step 4

Scleral and conjunctival closure

Am I a CLASS candidate?

Many Glaucoma patients are dissatisfied with the current treatment available to them. Eye drops application is not always an easy task, and inappropriate usage inevitably results in limited adherence. Additionally, eye drop  application has proven ineffective in the long term and thus costly. On the surgical spectrum, though penetrative surgeries are effective in the long run they carry a high post-operation complication rate.

If you are diagnosed with mild, moderate or severe, primary or secondary Open-Angle Glaucoma (OAG), including Pseudo-Exfoliative Glaucoma (PEXG), you are a candidate for undergoing a CLASS procedure.

“IOPtima’s CLASS procedure has true advantages over the Trabeculectomy surgery, as it offers an excellent safety profile with an ease of use. It can lower pressure into the lower teens and reduce the patient’s reliance on Glaucoma medications without subjecting the eye to the risks of Trabeculectomy.”

 

The CLASS procedure is also suitable for patients with Cataract and can be combined with Cataract surgeries.

Please consult your ophthalmologist regarding the possibility of undergoing a CLASS procedure or a combined Cataract surgery.