Impact case study database

The research of Wormstone and team in developing and enhancing the capsular bag model has achieved significant impacts on commerce, production and practitioners in the health sector, so improving the health and wellbeing of people. Specifically, it has: (a) enabled the rapid testing of novel clinical concepts, leading to the development and marketing of ocular products for a number of companies, so generating significant revenue; (b) positively impacted practitioners (surgeons); and (c) led to better outcomes and improved vision in many patients worldwide, immensely benefiting their quality of life.

(a) Impact on development and marketing of ocular products: The capsular bag model has played a key role in the development and evaluation of several intraocular lenses (IOL) including: the "bag-in-the-lens" intraocular lens (Morcher Type 89™); AnewOptics Zephyr™; Hoya Vivinex™; and Hoya Nanex™ [R5, R6; S1-S5]. These form part of a global intraocular lens market whose size was estimated to reach USD4,200,000,000 (12-2017) in 2020. To take the leading examples:

Bag-in-the-lens intraocular lens: Wormstone's research facilitated the development of this highly successful intraocular lens, which, since 2014, has been implanted in patients in more than 10,000 cataract operations in Europe [S1]. The Emeritus Head and Chair of the Department of Ophthalmology, Antwerp University Hospital, Belgium, who is the inventor of this lens and regularly implants it into patients in cataract surgery, stated, “The capsular bag model was an invaluable tool in translating my original concept to a clinical product” [S1]. The clinical outcomes from the large number of implantations of this lens are impressive. Specifically, in a five-year follow-up study, under 10% of children required additional surgical treatment after receiving the bag-in-the-lens intraocular lens [S2], whereas, with conventional surgery and standard intraocular lens implantation, 100% of children would have required it.

HOYA Vivinex™ and HOYA Nanex™ intraocular lenses: Since 2017, following an approach by the company on the basis of his research record and expertise, Wormstone has served as a consultant for HOYA Surgical Optics, one of the largest intraocular lens manufacturers globally, to aid their product development programme [S3]. Wormstone’s graded culture suspended capsular bag model [R6] found that the HOYA Vivinex™ intraocular lens had an overall better level of anti-posterior capsule opacification performance than the market-leading intraocular lens. The data from these studies, obtained within months [R6], predicted clinical outcomes that took years to obtain [S4]. As the HOYA Surgical Optics Global Product and Marketing Directors stated, “The capsular bag model is, therefore, a very powerful clinically relevant tool that can be used to evaluate and develop IOL performance” [S3]. They also stated, “The quality of the work and the significance of the published findings provided by Prof. Wormstone, using the capsular bag model, have greatly aided our ability to market our products” [S3].

In 2018 Wormstone presented his work on the capsular bag model as a keynote speaker at the HOYA symposium in Vienna, Austria, to an audience of approximately 300 ophthalmic surgeons, assembled as potential end-users of HOYA products. This presentation, along with follow-up content, was then used by the company for its marketing. As the HOYA Surgical Optics Global Product and Marketing Directors stated, “ The presentation in Vienna was recorded and is available in the HOYA collection on the Eyetube web platform. Prof. Wormstone’s work was also a key element in an advertorial published in ‘The Ophthalmologist’ which was followed by a feature article highlighting the capsular bag model and its demonstration of the performance of Vivinex™. A further feature article was published in ‘Eurotimes’ [magazine of the European Society of Cataract and Refractive Surgeons] . Collectively these publications have a readership of over 50,000 internationally, the majority of which are ophthalmic surgeons” [S3, S5]. In his capacity as consultant, Wormstone also used the capsular bag model in the preclinical development and assessment of the HOYA Nanex™ IOL (designed for microincision cataract surgery), which was added to the HOYA clinical product portfolio in 2019 [S3].

Referring to the UEA capsular bag studies, HOYA Global Product and Marketing Directors stated, “These activities have contributed to the continued growth and success of HOYA Surgical Optics and our products. HOYA Surgical Optics is now the world’s third largest IOL manufacturer globally, and has been the fastest growing of the largest IOL manufacturers in recent years. Professor Wormstone and his work on the capsular bag model continue to impact on the success of our company...” [S3].

(b) Impact on practitioners: Wormstone has delivered several invited talks at practitioner-based events, including: 100% Optical (2017) [S6]; the Cambridge Ophthalmological Symposium (2019) [S7-S8]; and two HOYA symposia (2017 and 2018), allowing him to present his research directly to ophthalmic surgeons [S3]. Wormstone's presentations, in addition to his publications in peer-reviewed journals and practitioner-based magazines, have achieved impact through informing clinicians of relative intraocular lens performance [S3, S6-S8]. For example, the Associate Professor of Ophthalmology, Ludwig-Maximillians-University of Munich, Germany, a distinguished and experienced cataract surgeon, approached Wormstone following a keynote lecture. Wormstone then visited her in Munich to pass on his knowledge of the capsular bag model and provide practical feedback. This technique has been fundamental in this practitioner's research strategy and clinical practice from 2014 onwards and, as she has stated, “The capsular bag model developed by Prof Wormstone has had a marked impact on cataract surgery....The data provided using the capsular bag model, therefore, provides scientifically rigorous findings that can inform the surgeon and aid their selection of IOL for their patients” [S9].

(c) Impact on patients: The ultimate beneficiaries of advances made using the capsular bag model as an experimental and evaluation tool are patients. As detailed above, the bag-in-the-lens intraocular lens has led to much improved clinical outcomes for children [S1, S2]. To quote further the Emeritus Head and Chair of the Department of Ophthalmology, University Hospital, Antwerp, Belgium, it “...has provided and maintained vision in tens of thousands of cataract patients” [S1]. In addition, of the best-selling intraocular lenses, HOYA Vivinex™ continues to increase its market share and offers improved clinical outcomes relative to the current market leader, such that posterior capsule opacification is better managed and the need for laser surgery is reduced [R6, S4]. Ultimately, benefits to patients across the world result from decisions made by surgeons and the impact the capsular bag model has on this process is highlighted in the following statement by the Associate Professor of Ophthalmology, Ludwig-Maximillians-University of Munich, Germany: “I have drawn on my knowledge from capsular bag studies to guide colleagues on their IOL choices, which I believe have positively impacted on many patients since 2014” [S9].