The most versatile laser in the market The Opto FastPulse™ laser is a next generation multi-purpose 810nm diode laser photocoagulator designed for use by ophthalmic surgeons for the treatment of various Retinal and Glaucoma diseases. It is the safest and most versatile single frequency laser in the ophthalmic market due to its unique micro pulse and conventional continuous wavelength modalities. Micro pulse is a novel laser application designed to achieve optimum clinical outcomes whilst reducing laser-induced thermal damage compared to conventional continuous wavelengths lasers and modalities.

Highlights

Unmatched Clinical Versatility

The Opto FastPulse™ is increasingly regarded as a more versatile ‘tool of trade’ for the Ophthalmologist due to its 810nm Continuous Wavelength and micro pulse modalities. These modalities allow for significantly greater clinical applications and procedures than other contemporary wavelength lasers with significantly higher safety margins and greater economics due to much lower costs of ownership. The 810nm infrared lasers offers better wavelength stability performance than conventional 532nm or Argon Lasers, whilst its invisible wavelength allows for treatment of Transscleral Procedures (as the sclera is translucent for this wavelength but opaque to visible light) as well as Retinopathy of Prematurity (ROP) due to lesser required treatment power and smaller retinal tissue destruction.

Additional Features

Intelligent, Intuitive and Robust Design

DynamicControl™: The Opto FastPulse™ has the unique DynamicControl™ power adjustment system that allows the user to precisely set the power requirements across the whole power range, thus enhancing user convenience. The majority of competitors’ systems offer power steps in the range of 50-100mW whereas DynamicControl™ allows for power steps of 10mW. DynamicControl™ adjusts the power step according to the user’s power knob turning speed. This system allows for fine adjustment giving the Ophthalmologist unsurpassed control over one of the most important treatment parameters, the power setting.

Portable: The Opto FastPulse™ is a truly portable product that weighs only 6.5Kgs and has small dimensions. The console and delivery devices come in their purpose designed shock resistant hard cases. The delivery devices are easy to install and remove and the console has automatic recognition of the selected delivery device. These features, combined with the robustness of the product make the Opto FastPulse™ easy and convenient to transport to hospitals and private clinics on a routine basis.

Memory Function: The Opto FastPulse™ has a unique function that allows the user to record ophthalmologists preferred laser initial parameter settings. This function saves time and makes operation easier.

Sophisticated Treatment Software: Depending on the treatment mode the Opto FastPulse™, sophisticated software calculates and displays the essential treatment parameters based on the inputs and settings from the Ophthalmologist. The laser simultaneously displays irradiance, laser spot size, spot size at the retina, treatment power and duration as well as total energy delivered, providing the Ophthalmologist with simple yet clear control, coupled with unparalleled safety of operation.

Alphanumeric Display: The Opto FastPulse™ has a bright and clear alphanumeric display that is highly visible in all ambient light conditions making the parameters easier to read in dark, low light or highly illuminated rooms. The display has 2 lines of 20 alphanumeric characters in which all the important treatment parameters and operating messages are shown.

Modular and Field Serviceable: The Opto FastPulse™ laser console and UniFit™ Slit Lamp Adapter are modular and field serviceable, resulting in reduced downtime, as an authorised Opto Service Representative at the Ophthalmologists convenience can provide service support in the field. The laser console has a sophisticated Diagnostic Mode that provides the authorised Opto Service Representative with all the important operational parameters in order to promptly find and rectify any problem.

Clinical Applications

The main Opto FastPulse™ laser clinical applications are:

Micropulse Trabeculoplasty (MLT)

• Primary Open-Angle Glaucoma

Diabetic Macular Edema

Conventional & Sub-threshold Retinal Photocoagulation

• Diabetic Retinopathy
• Central serous chorio-retinopathy
• Central/Branch Retinal Vein Occlusion
• Retinopathy of Prematurity (ROP)
• Retinal Tears, Holes and Detachments

Transscleral Procedures

• Refractory glaucoma, retinal tears and detachments

Transpupillary Thermo Therapy (TTT)

• Ocular Tumours

Included Accessories

• Hard Carry Case for Laser Console
• Hard Carry Case for Slit Lamp Adapter (if purchasing with Slit Lamp Adapter)
• Endoprobe Autokey
• Remote interlock bypass connector
• Foot Pedal
• Tonometer Post (with any Slit Lamp Adapter)

Optional Accessories

A wide range of delivery devices and accessories are available with the Opto FastPulse™ Laser. This allows Ophthalmologists to perform several different therapeutic modalities with convenience and safety

UniFit™ Slit Lamp Adapter (SLA) is a fully adjustable slit lamp adaptor available with Small Spot Size (75, 125, 200, 300 & 500µm) and Large Spot Size (0.8, 1.0, 1.5, 2.5 & 4.3 mm) models indicated for Photocoagulation and TTT Procedures.

• Compatible with most Haag-Streit and Zeiss type Slit Lamps and clones
• Simple to install and remove

WelchAllyn integrated Laser Integrated Ophthalmoscope (LIO): The new lightweight WelchAllyn integrated LIO provides a unique control to adjust aperture size and position. It is excellent for photocoagulation in the far periphery and treating patients in the supine position as well as in Retinopathy of Prematurity.

• Crystal clear laser safety filter provides enhanced distortion free viewing.
• Excellent for photocoagulation in the far periphery

Endo Ocular Probes: Opto Global offers a full range standard Endo-ocular and specialised Laser Treatment Probes for wide range clinical applications, whilst the Opto FastPulse™ Laser features a standard SMA type probe connector, provides ease and flexibility of choice of laser probe manufacturer.

• Straight, Curved, Aspirating & Illuminating
• Indicated for all Endophotocoagulation procedures, retinal tears and detachments
• Glaucoma Probes for Transscleral Cyclophotocoagulation (requires optional Glaucoma Probe Autokey)

Safety Filters: Opto Global offers a selection of manually adjusted Safety filters for a wide range of microscopes including Opto, Zeiss, Leica and Moeller Wedel.

Infrared or Multi-Wavelength Safety Glasses:Wrap-around for extended protection for clinical personnel

Additional Information

Micro pulse (Sub-Threshold) Photocoagulation

• Theory of Operation: Recent research has demonstrated that the therapeutic effect of laser photocoagulation are not generated by the necrosis created by thermal damage but rather from biological activity generated around the target spot, where temperature elevation is lower and below the lethal threshold. Therefore it may be possible to achieve the desired therapeutic effect and resolve various retinal disorders without causing iatrogenic burn caused by visible photocoagulation. A less destructive therapy would allow the ophthalmology to treat disorders at an early stage, possibly achieving stabilization or improvement of less compromised visual function.

• Mounting evidence indicates that the primary mediators of the complications of retinal vascular disease may be cytokines, such as VEGF and PEDF, derived from the RPE. In the absence of thermal retinal destruction micro pulse photocoagulation may somehow influence the RPE to alter its production of such potent cellular factors. Such a mechanism of action could explain the effectiveness of micro pulse photocoagulation.

• Mechanism of Action: Micro pulse technique exploits three key principals to achieve clinically effective yet atraumatic photocoagulation:

  Selectivity: Micropulsing targets the retinal pigment epithelium (RPE) and isolates the heat to this tissue.

  Cold photocoagulation: Low-duty cycle (5% to 15% on and 95% to 85% off) allows for relaxation time between pulses, thus thermal damage is minimized, creating a significant safety margin over CW laser.

  Cumulative effect: By increasing the density of the low-intensity treatment.

  Micropulse diode laser photocoagulation allows for relaxation time between pulses (usually 10 15% duty cycle) thus preventing the heat generated at the RPE from reaching the neurosensory retina.

  The following diagram presents an example of a typical 200ms pulse in Micropulse and conventional pulse modes.

• Clinical Features: Micropulse Photocoagulation with 810nm offers significant clinical advantages over green lasers (532nm and 514nm) as well as standard diode lasers (810nm) and it deserves a different understanding and approach to its use. For example, Ophthalmologists that have become proficient in the use of green lasers to perform photocoagulation will require a fine adjustment to their operating technique when approaching the use of the Opto FastPulse™ laser for photocoagulation procedures. The following offers a brief précis on the relative advantages and differences when considering the use of 810nm.
• Advantages of Micropulse (Sub-Threshold) Photocoagulation:
  • As the micro pulse Photocoagulation causes no collateral damage, this technique offers the surgeon the ability to treat retinal disorders at a much earlier stage, thus increasing the chances of vision improvement or stabilization.
  • Micro Pulse photocoagulation has shown to increase safety margin by avoiding inadvertent threshold lesions by 10-fold over continuous wave lasers.
  • Because of the lack of laser induced retinal damage, Micropulse photocoagulation can be repeated as necessary over time until the desired clinical effect is achieved.
  • As Micropulse diode laser photocoagulation allows for relaxation time between pulses preventing the heat generation from reaching the neurosensory retina, Ophthalmologists can treat lesions much closer to the Fovea than from conventional lasers.
  • Micropulse photocoagulation is painless whereas conventional photocoagulation may require anaesthesia and the treatment may be divided into stages to minimize treatment pain and post operative inflammation.
  • The 810nm laser is not visible, thus making the treatment less of an inconvenience to the patient and treating Ophthalmologist. The visible green flash from 532nm and argon lasers can lead to photophobia like conditions, causing further anxiety and discomfort to the patient.
  • Normal vision is restored sooner after treatment than other wavelengths such as green 532nm, a clinical outcome preferred by both patient and Ophthalmologist.
  • The 810nm laser beam is less scattered than a green laser, hence, facilitating easier photocoagulation with eyes presenting with opacities such as cataracts, oedematous corneas and cloudy vitreous. This also offers the Ophthalmologists more flexibility in their treatment choices.
  • The 810nm wavelength is not absorbed by haemoglobin; therefore, it may be used to treat through haemorrhagic conditions in the vitreous and through a thin layer of blood on the retina.
  • Currently there are no known side effects accompanying the Micropulse Laser Photocoagulation treatment.
• As there are no visible changes which occurs to the lesions treated with micro pulse, the procedure may be at first difficult to titrate and it is therefore vital that the ophthalmologist understands the micro pulse (sub-threshold) photocoagulation theory and techniques. Due to previously unavailable technologies, Ophthalmologists have become proficient and accustomed to conventional photocoagulation techniques using the white burn mark on the retina as the treatment endpoint, therefore those who are new to Micropulse photocoagulation will often ask questions such as “how do I know the laser works if it does not leave burn marks” and “how do I know if I have completed my treatment if I cannot see any marks”. In such cases it is always important to refer to the fact that the therapeutic effect of laser photocoagulation is not generated by the necrosis created by thermal damage but rather from biological activity generated around the target spot thus the burn mark is only an unwanted element (side-effect) of photocoagulation.

Micropulse Laser Trabeculoplasty (MLT)

• Theory of Operation: Micropulse laser trabeculoplasty (MLT) is a new, non-coagulative (no collateral damage) laser therapy for reducing Intra Ocular Pressure (IOP) in eyes with open-angle glaucoma exfoliation syndrome glaucoma, pigmentary glaucoma, normal-tension glaucoma and ocular hypertension.
• Ongoing research demonstrates that provides the same IOP lowering effects as Selective Laser Trabeculoplasty (SLT), and Argon Laser Trabeculoplasty (ALT) with less energy and inflammation.
• Mechanism of Action: While the full mechanism of action of any Laser Trabeculoplasty procedure isn’t completely understood, clinical studies demonstrate that the sub-thermal laser excitement of MLT to the cell, triggers a cellular cascade, stimulating a healing response leading to a drop of Intra Ocular Pressure (IOP).
• This works by application of infrared 810nm diode laser light and an induction of low laser irradiance delivered in a train of micro pulses. The laser aims at creating non-lethal temperature gradients at the pigmented cells, just sufficient to produce inflammation, macrophages recruitment, release of cytokines and a biological cellular healing cascade leading to induction of cell division and metalloproteinases expression in the trabecular matrix.
  • Pigment laden cells both in superficial and deep layers of the Trabecular Meshwork are activated by MLT, without affecting the underlying structure.
  • Macrophage recruitment takes place to remove damaged cells.
  • Trabecular meshwork cells divide to replace the lost cells.
  • Release of growth factors (such as cytokines) which regulate the structure of the Trabecular Meshwork beams.
  • A healthier, more porous trabecular meshwork restores balanced aqueous outflow.
  • This process occurs differently from between people but usually will require two treatments per eye, separating the treatment by two weeks.
• Clinical Features: The term Laser Trabeculoplasty (LT) was first described in 1974 by Prof. Worthen and Prof. Whickham. Laser Trabeculoplasty is based on the concept of applying laser to the Trabecular Meshwork (TM) which subsequently increases the aqueous outflow facility through the normal drainage pathways of the eye reducing the intraocular pressure.

Nowadays the Laser Trabeculoplasty application is the most common mode of glaucoma treatment. From the traditional Argon Laser Trabeculoplasty (ALT), through to the Selective Laser Trabeculoplasty (SLT) and now latest Micropulse Laser Trabeculoplasty (MLT) these three trabeculoplasty procedures appear to share a similar mechanism of action and differ by technology, the laser wavelength and importantly the amount laser threshold damage to the tissue.

• Ongoing research and evidence supports the safety and efficacy of MLT more widely accepting it as a “standard of care” with potentially greater clinical efficacy and versatility and lower costs of ownership as compared to similar single-platform trabeculoplasty lasers.
• Advantages of Micropulse Laser Trabeculoplasty (MLT)
  • MLT is not associated with systemic side effects with minimal follow up requirements.
  • MLT utilizes selective photothermolysis to target only specific cells, leaving the surrounding tissue intact.
  • MLT stimulates the body's natural mechanisms to enhance outflow of the fluid in the eye.
  • The short Micropulse durations of MLT are below the thermal relaxation time of the TM tissue therefore eliminates the incidence of thermal damage.
  • MLT is painless and better tolerated by the patient during the procedure.
  • Although MLT causes no scarring which minimizes the risk for late IOP rise, the treatment can be repeated without causing harm or further complications.
  • MLT is considered as effective as SLT and ALT with less inflammatory reaction and less disruption of the blood-aqueous barrier.
  • MLT proves to be as effective as any single drug for IOP reduction, and can be used as initial therapy in preference to drugs.
  • The multipurpose platform and clinical versatility in other retinal applications potentially reduces the cost of system ownership from other single platform Laser Trabeculoplasty systems.
  • MLT effects on the Trabecular Meshwork are better controlled due to bigger range of system settings than SLT and ALT lasers, such as higher power range, the laser on and off time, as well as the number and repetition rate of the pulses.

    The above scanning electron microscopy images of Trabecular Meshwork with indicate no thermal effects on the Trabecular Meshwork after the MLT and SLT applications, whereas indicate an evident thermal effect after ALT application.

Opto FastPulse™ is currently pending FDA approval for sale in USA