Clareon AutonoMe IOL and Delivery System Launched

Australian Ophthalmologists trialling Alcon's Clareon AutonoMe intraocular lens (IOL) and delivery system have been impressed with its ease of use and the visual outcomes.

Alcon's Clareon AutonoMe intraocular lens (IOL) and delivery system is an advanced monofocal IOL with the "first and only automated, disposable, preloaded IOL delivery system".1 It builds on the success of Alcon's AcrySof Platform, which has been implanted over 100 million times worldwide.2,3

Dr. Michael Lawless (Vision Eye Institute); Dr. Smita Agarwal (Wollongong Eye Specialists) and Dr. Rick Wolfe (Vista Eyes) were all enthusiastic about the new IOL and its delivery system, which Dr. Michael Lawless described as "the best injector I have ever used" with a speed that can be adjusted according to surgeon preference, "in the same way that a car accelerator works".

The injector, which comes in an easy to open package, pre-loaded with the IOL, is powered by a small cylinder of carbon dioxide.

the best injector I have ever used" with a speed that can be adjusted according to surgeon preference, "in the same way that a car accelerator works

"The IOL is easily inspected under the microscope and then the surgeon, with a click of the thumb, advances the IOL to the correct position and can view that the lens is ready for injection. There is then a 60 second opportunity to inject the lens," said Dr. Lawless.

Dr. Rick Wolfe said "smooth and absolute control of the speed of insertion" optimises results. "With manual plunger injectors the challenge has always been to deliver the IOL at constant speed with some, but not too much resistance. Some injectors speed up at the end of travel because of lessened resistance, and sometimes because of the release of energy stored up with the compression of low refractive index hydrophilic IOLs. This can be dangerous with possible damage to intraocular structures. The incision is also dilated and possibly torn in an uncontrolled way." He added, "While smooth insertion can be achieved with the previous Monarch II system, this screw system requires two hands", he said. "The Clareon AutonoMe delivery system requires just one hand to operate, leaving the other free to steady the globe and guide the IOL."

REDUCED TIME AND RISKS

Dr. Smita Agarwal said the pre-loaded IOL delivery system reduces device preparation time and total case time by avoiding manual loading of the lens. Additionally, she said, "The pre-loaded Alcon platform has definitely reduced the risk of scratching the lens which could potentially happen if not handled carefully in the theatre. The risk of lens contamination and hence post-surgical infections are minimised… It is also very easy for the nurses to prime and in my hands, the longer nozzle helps lens insertion, either wound assisted or through a wound of 2.3 mm," she added.

Dr. Lawless said the system is further enhanced with inclusion of a guard, which ensures the wound is not harmed or enlarged by the injection process. "I like the fact that the quality of the wound is not stretched or altered, leading to a better seal without the need, in most cases, for hydration," he said.

The Alcon Clareon AutonoMe intraocular lens and delivery system. Image reproduced with the permission of Alcon

SHORT LEARNING CURVE

Drs. Agarwal, Lawless and Wolfe all agreed that the Clareon AutonoMe delivery system was easy to learn to use.

"The simplicity of operation belies the complexity of the design," said Dr. Wolfe. "Alcon trainers take new surgeons through 20 cases, but the reality is operation is so simple and intuitive I think it is unnecessary… The advance lever is depressed by the surgeon and the IOL is advanced to the injection position. Once the tip is engaged in the incision up to the stop, it is not possible to insert the injector too far and stretch the incision, then the lever is depressed. The response is perfectly linear and the surgeon has full control. Full depression advances the IOL at 3mm/sec."

Dr. Agarwal said she felt comfortable with the new delivery system and in control of the speed of insertion after performing just five cases. "I had to hold the lens insertor a bit more perpendicularly than has been the case previously, to ensure the lens went into the bag. Lens delivery was very smooth and it unfolded more quickly in the eye. Occasionally, during aspiration the port sticks to the optic due to the tacky nature of the material. However, the lens doesn't get scratched while aligning it in the bag," she said.

Dr. Lawless had a similar experience. "At the time of insertion the injector has to be held much like a pencil in order for the orientation to be correct, and you do have to bring the microscope away from the field in order to inspect the traverse of the IOL and then bring the microscope back. This just took a few cases to become comfortable with."

Dr. Agarwal said her patients have found their vision to be brighter and clearer with the new Clareon IOL

SUCCESSFUL PATIENT RESULTS

Made from a patented, innovative optic polymer material with an advanced design, Dr. Wolfe said the new Clareon IOL offers several positives for both surgeon and patient. "Having tested this lens, it seems to have the important features of AcrySof, such as high refractive index, capsular adhesion, lens epithelial cell adhesion and modulation of lens epithelial cell metaplasia, so important in preventing decentration, axial movement, PCO and capsular contraction syndrome."

Additionally he said a lower glass transition temperature makes it more pliable at room and AC temperature, and easier to manipulate inside the eye than the Acrysoft.

"One gets quite a surprise viewing Clareon on the slit lamp – because surface scatter is so low, it is sometimes difficult to see. Alcon uses the term 'unsurpassed clarity' to describe this lens and, having listened to the scientific reviews of this lens and evaluated it myself, I completely agree. In addition, important modifications to the IOL have been made, aimed at reducing positive dysphotopsias."

Dr. Agarwal said her patients have found their vision to be brighter and clearer with the new Clareon IOL. "I have used this lens in the second eye of some patients and they do not report any glare postoperatively," she said.

FURTHER ADVANCES AWAITED

There is one limitation with the Clareon IOL and that is that it is currently only available in an advanced monofocal design. "Monofocal spheres are uncommon IOLs to use. We hope soon it will come in at least lower toric powers and then maybe trifocal, which will vastly increase utility," said Dr. Wolfe.

If Alcon lives up to Dr. Agarwal's experience, this is likely to happen sooner rather than later. "Alcon always involves surgeons when they come up with new technology and listens to any feedback. This platform, with its consistent and smooth delivery system, has again demonstrated their commitment to optimising the surgical experience for surgeons," she said.

References:

1. Alcon data on file, 2017, Schematic Model Eye and In Vitro Evaluation of Positive Dysphotopsia or Glare Types Photic Phenomena.
2. Alcon Data On File, AcrySof Units Sold-1993-2017.
3. 2016 MS Global IOL Market Report.