A brochure, for Ultralase laser eye surgery, distributed in October 2010 made a number of claims about the service they offered.
Optical Express challenged whether:
1. the claim that the Ultra-Elite treatment used "the most advanced Wavefront technology" was misleading, because they understood that more advanced technology was available in that field, and
2. the claim that Ultra-Elite treatment "Corrects the most minute imperfections" was misleading, because they understood that no technology could correct all eye imperfections.
1. Ultralase said the laser they used had a specification that enabled the delivery of the most advanced aspheric wavefront technology available. They explained that "aspheric" referred to a lens designed to improve image quality by reducing imperfections or aberrations and that that concept had been used in spectacle lens and contact lens design for some years. Ultralase said wavefront technology had been applied to laser eye treatment for many years and worked by imaging the eye's entire optical system and measuring the focusing ability at numerous points in the eye. They explained that it created a "map" unique to each individual eye, which was the basis for treatment, and was able to treat higher order aberrations, not normally measured during an eye test, thereby producing better quality visual outcomes for the patient.
Ultralase believed that aspheric wavefront technology had a unique and patented method of addressing spherical aberration, a higher order aberration responsible for the denigration of the eye's image, that produced high quality results in comparison with wavefront technology. They provided the ASA with the results of studies they had undertaken on their patients, which they believed showed the quality of vision using aspheric wavefront guided treatment and in particular in the change to spherical aberration compared to standard wavefront treatment.
Ultralase said there were five other lasers used in the UK in addition to their own and they had compared them in terms of their ability to deliver a wavefront treatment, by matching the prescription range and comparing published results, where available. They believed the Technolas PerfectVision (TPV) laser that they used, supported by their own research, produced the best published outcome results in the UK.
Ultralase said the quality of wavefront-guided treatment was dependent on the laser delivering the treatment and its hardware and software capabilities. They said the TPV laser combined two beam shapes, "flat top" and "Gaussian beam", to create a beam that produced regular outer edge ablations. They said a published scientific report, which had compared the six lasers, confirmed that the other lasers had produced irregularities of the outer edge. They said the optic zone, the area of the cornea treated with the laser to optimise visual performance, was principally determined by pupil size. They said research had shown that larger treatment areas had been shown to produce better quality of vision and reduction in symptoms such as haloes, blurring and fluctuation. They said the TPV laser, and two other lasers, all recommended choosing an optic zone 0.2mm to 0.5mm larger than the patient's pupil. They said the TPV laser could treat an optic zone out to 8.5mm, larger than the other two competitor lasers.
Ultralase said the eye tracking system of the laser was also critical in the quality of the treatment outcome. They said all modern lasers had tracking systems that addressed horizontal and vertical eye movements, but only the TPV and one other laser was able to track the "z" axis, when the eye moved too close or too far away from the laser. They said the TPV laser included rotational eye tracking, because the eye had been shown to rotate during treatment. They said only one other laser could partially achieve rotational eye tracking with limited use in the UK.
Ultralase said the iris recognition feature of the TPV laser was also an important part of the treatment. It ensured the correct patient was being treated and measured and compensated for eye rotation. They acknowledged that three other lasers also had this feature. However, they added that the TPV had a unique element that calculated the interaction between different types of aberrations, in order to optimise the wavefront treatment. They believed this was important as research had shown interaction between aberrations could lead to sub-optimal results.
Ultralase believed that the combination of all those components in the TPV laser supported the claim that they delivered the "most advanced" wavefront treatment available. They also provided a study based on 802 treatments that they had carried out, which they believed showed the best set of laser vision correction results ever published by a UK clinic group.
2. Ultralase acknowledged that some aberrations were not of clinical significance and were comparable to "noise" in the visual signal. They said the brochure was intended for the general public, not doctors or technical experts, and believed that the claim "correct the most minute imperfections" would be understood by consumers to mean the level that would realistically be expected to have any significant impact on their vision.
The ASA considered that the claim "the most advanced Wavefront technology" would be understood by consumers to refer to better treatment and patient outcome than other treatments available. We understood that the TPV laser used in the Ultra Elite treatment included a number of software features that were different to other wavefront lasers and noted the published articles and studies provided by Ultralase to support their arguments that the TPV features helped to improve outcome results. Although we acknowledged that those articles and studies highlighted the advantages of the various components of the laser, we nonetheless considered that Ultralase's own study, based on 802 treatments, was the most relevant to support the claim in the brochure, because it was a retrospective study based on treatment outcome.
We noted the study recorded the efficacy results a month after treatment of the 802 treatments carried out on 494 patients. The treatments had been conducted on a range of patients across 25 Ultralase clinics and by multiple surgeons. The results showed 99.6% to 6/12 (driving test vision), 95.8% to 6/6 (perfect vision) and 95.4% to =+/- 50, which Ultralase believed to be the best results ever published by a UK clinic group.
However, we considered that the claim "the most advanced Wavefront technology" was an absolute claim and noted that, although the '802 Study' was robust, it was not a comparative study. We understood that Ultralase compared the study results with comparative data on competitor websites, but not all their competitors published such data. Although the results might have been the best results published by a UK clinic group to date we considered that, because Ultralase was unable to compare their results with all competitors, we considered that they had been unable to substantiate the absolute claim that they offered the "the most advanced Wavefront technology". We therefore concluded that the claim was misleading.
On this point the brochure breached CAP Code (Edition 12) rules 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. (Misleading advertising), 3.7 3.7 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation. (Substantiation), 3.11 3.11 Marketing communications must not mislead consumers by exaggerating the capability or performance of a product. (Exaggeration) and 3.33 3.33 Marketing communications that include a comparison with an identifiable competitor must not mislead, or be likely to mislead, the consumer about either the advertised product or the competing product. (Comparisons with identifiable competitors).
We understood that the brochure was aimed at consumers rather than eye specialists, who were likely to understand that laser treatment was unable to correct all vision flaws. However, we considered that consumers would understand the claim "Corrects the most minute imperfections" to mean that the treatment would rectify all eye imperfections, even the smallest, which we understood was not the case. Although the laser could correct minute imperfections, we considered that by phrasing the claim in the way that they had, Ultralase had given the impression that even the smallest imperfection could be corrected. Although we noted their argument that some aberrations were not of clinical significance, we did not agree that the claim would be understood by consumers to relate only to those imperfections that would be expected to have any significant impact on their vision. Because we understood that it was not possible to correct the smallest imperfections, we considered that the claim had exaggerated the capabilities of the treatment and was misleading.
On this point, the brochure breached CAP Code (Edition 12) rules 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. (Misleading advertising), 3.7 3.7 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation. (Substantiation) and 3.11 3.11 Marketing communications must not mislead consumers by exaggerating the capability or performance of a product. (Exaggeration).
The brochure must not appear again in its current form. We told Ultralase to ensure that they held robust evidence to support future superiority claims and not to exaggerate the laser's capabilities.