Ellex Medical Lasers has released its first case study results from commercial users for its 2RT retinal rejuvenation laser. 2RT is currently being used commercially in NSW and Victoria, and internationally, in early age-related macular degeneration (AMD) patients. In an announcement to the Australian Stock Exchange (14 September 2015) the company stated that as of mid-August 2015, commercial 2RT procedures had been carried out on approximately 1,000 patients.
Retinal Rejuvenation Therapy (2RT) is a non-thermal three-nanosecond pulse retinal laser therapy, which has been shown, in clinical and scientific studies, to improve retinal function and to halt or delay the degenerative processes that cause retinal disease. According to Ellex, the short green (532 nm) YAG laser pulse emitted by 2RT reduces drusen and can produce bilateral improvements in macular appearance and function in high-risk early AMD patients.1 Unlike conventional laser photocoagulation, 2RT does not damage the nuclear retina. 2RT uses solid-state, nanosecond laser technology delivered through a patented beam profile. The treatment approach selectively targets individual organelles (specialised cells) within the retinal pigment epithelium (RPE) in order to induce a therapeutic effect without causing thermal damage to the underlying Bruch’s membrane and overlying photoreceptors.2
Writing in The Ophthalmologist, Wilson Heriot reported, “What I have found, when comparing the microperimetry assessment of patients with early AMD before and after 2RT treatment, is that 2RT treatment was associated with large improvements in contrast sensitivity. By comparison, contrast sensitivity outcomes following standard thermal photocoagulation are weaker, owing to the blind spot caused by the thermal injury and the subsequent lack of functional improvement.”3
Dr. Christopher Kiss PhD (Austria) and Dr. David Worsley MB, ChB, Dip Obs, FRANZCO (New Zealand) released results of their clinical experience with 2RT in conjunction with Ellex’s commercial release of 2RT at the European Society of Cataract and Refractive Surgeons (ESCRS) meeting in Barcelona, Spain, 5-9 September 2015.
Dr. Worsley reported on an 81-year old female patient with bilateral confluent soft drusen and pigmentary change. The patient had a past history of bilateral cataract surgery. Dr. Worsley reported that MAIA macular function assessment indicated significant functional defect at the majority of sensitivity points. Treatment with 2RT resulted in drusen resolution and concurrent improvement in BCVA and contrast sensitivity. “2RT Nano second laser has demonstrated an effective intervention for degeneration and improvement in macular function,” said Dr. Worsley.
Dr. Christopher Kiss reported on an 84-year old female patient with large confluent soft drusen with few hyper-pigmented areas. He said some drusen had calcified and that the drusen was located directly foveal. The patient had advanced age related macular degeneration in the fellow eye and significant functional defect at the majority of sensitivity points, as per MAIA macular function assessment. Dr. Kiss reported that treatment with 2RT resulted in increased BCVA and contrast sensitivity and marked reduction in drusen.
Dr. Kiss similarly concluded, “for me this case represents 2RT providing a benefit in macular function and appearance in patients with drusen and functional defects. I will continue to consider 2RT for further intermediate AMD patients”.
Ellex is currently accumulating case series data as part of a post-market surveillance program. The company’s CEO, Tom Spurling said, “The long term (LEAD) clinical trial on 2RT being conducted in Australia is expected to ultimately provide quantitative data on the efficacy of 2RT. In the meantime our early adopters are providing important information about 2RT’s clinical usage and potential.” The three-year results from the multi-center (LEAD) trial will not be released until 2019.
At nine months post-operative the application of 2RT is shown to achieve a marked reduction in the size and area of drusen. Importantly, OCT imaging confirms no damage to the sensory retina.
At nine months post-operative the application of 2RT is shown to achieve a marked reduction in the size and area of drusen. Importantly, OCT imaging confirms no damage to the sensory retina.
The company intends to roll out 2RT on broader scale in Australia and internationally as it builds upon its existing clinical evidence.
References
1. Guymer, R.H., et al., Nanosecond-laser application in intermediate AMD – 12-month results of fundus appearance and macular function. Clin Experiment Ophthalmol. 2013 Oct 3. doi: 10.1111/ceo.12247)
2. I. Jobling et al., Nanosecond Laser Therapy Reverses Pathologic and Molecular Changes in Age-Related Macular Degeneration without Retinal Damage. The FASEB Journal 29, no. 2 (February 1, 2015): 696–710, doi:10.1096/fj.14-262444.
3. W. Heriot., Taking the Heat Out of Retinal Laser Therapy. www.theophthalmologist.com/issues/0815/taking-the-heat-out-of-retinal-laser-therapy
