眼科医疗器械的发展：视力保健的创新进展

Lisa Moore博士，医疗器械和诊断开发执行总监

Brian Guthrie，MBA，战略交付与增长副总监

视觉往往被视为最重要的感官之一。正因如此，通过各种创新的医疗器械，视力的诊断和治疗手段正取得重大进展。加快这类器械的全球审批和上市至关重要，因为其治疗的很多疾病本质上是进行性的。Fortrea拥有在眼科学和医疗器械开发方面经验丰富的团队，在设计和实施这一重要治疗领域的临床试验方面有着深厚的经验。

展望未来

近视是一种进行性疾病，全球发病率呈上升趋势。 Projections now indicate that by 2050, 49.8% of the population will suffer from myopia.¹ Uncorrected high myopia is the second most common cause of blindness in the elderly. In some countries, for instance, in China and Japan, myopia-related sequelae, such as myopic macular degeneration and retinal detachments, have become the leading cause of blindness.²

The incidence and disease progression in young children is also increasing in the Asia-Pacific region.¹ At the forefront of myopia intervention are clinical studies using defocus or dual focus lenses (spectacles and contact lenses) to slow progression of the disease in children. Since early childhood is where the most myopic eye growth occurs, providing options for disease control are a key focus.³ While these studies are still underway to assess durability and long-term reduction in changes to vision, the evidence from several trials is very promising.  

由于基础医疗机构缺乏筛查和诊断工具，因此无法早期发现衰弱性视网膜疾病，如糖尿病视网膜病变和黄斑变性。而对这类疾病致盲风险最高的关键人群的筛查缺乏则使情况更加严重，因为早期识别这些疾病可大大增加保住或改善视觉功能的机会。

Developing point of care diagnostic tools for screening using artificial intelligence (AI) can lead to earlier and more accurate detection and better outcomes.⁴ There are a number of AI-driven solutions under study and recently approved that demonstrate high specificity and sensitivity, with an aim to provide equity in access and speed referral to specialist for treatment.

应对医疗器械和诊断临床试验的苛刻挑战

Running trials in this therapeutic area often requires:

• Working with a pediatric-biased population and managing the complications that are associated with recruiting this vulnerable patient group
• 设计并协助患者保留并保持对方案的依从性，同时通过多年随访和长时间的门诊访视来评估近视眼的发展和屈光不正
• 在有商业批准的双焦点镜片的情况下，招募需要对照组（单视矫正镜片）的随机试验
• Building a meaningful diversity plan and working with regulators, recognizing that this therapeutic area disproportionately impacts people of Asian ethnicity
  

Meeting these challenges requires a range of specialist skills and capabilities including specialist medical device (including software as a device) clinical trial therapeutic area expertise, a global network of sites, experience of working with niche demographic populations and a regulatory consulting team familiar with diversity planning and the special needs of medical device development.

As a CRO with a dedicated team of medical device development experts, and backed up by a global clinical trial delivery team, we offer:

• Ophthalmology research experience: Fortrea’s ophthalmic staff have deep scientific and regulatory experience from delivering more than 110 global, patient-centric ophthalmology clinical trials for emerging biotech companies in the last five years alone. 其中包括在美国、欧洲和亚太地区拥有眼科医生和验光师医务人员，他们可以支持我们进行的研究，而且与研究者保持着良好关系，同时了解该地区的医疗标准。我们拥有450多名具有眼科学工作经验的员工。
• A dedicated Rare Disease, Advanced Therapies and Pediatric Team (RAPT): This team works across the life span of the project to customize operational strategy, anticipate and mitigate risk, improve efficiency and data quality and to focus the program on the needs of the study from the pediatric and rare disease perspective.
• A dedicated Medical Device development team with specialists in Software as a Medical Device: As a dedicated business unit within Fortrea, our medical device business is ISO 13485 certified and works to ISO 14155 guidelines for all studies.

By developing an optimized strategy combined with the right sites and deploying appropriate technologies, together, we can drive advances in vision care and make a meaningful impact for millions worldwide.

请访问医疗器械和诊断解决方案，进一步了解我们如何帮助您找到适当的研究中心和患者人群，以支持您的眼科学和医疗器械试验。

¹ Holden BA, Fricke TR, Wilson DA,等人. 1年至2000年全球近视和高度近视患病率及其时间趋势。 Ophthalmology 2016;123:1036–42

² Tang Y, Wang X, Wang J, et al. Prevalence and Causes of Visual Impairment in a Chinese Adult Population: The Taizhou Eye Study. Ophthalmology 2015;122:1480–8.

³ Chamberlain, PB; Bradley, A, et al. Long-term Effect of Dual-focus Contact Lenses on Myopia Progression in Children: A 6-year Multicenter Clinical Trial. Optometry and Vision Science 99(3):p 204-212, March 2022.

4 Lim J, Regillo C, et al. The EyeArt Study Subgroup. Artificial Intelligence Detection of Diabetic Retinopathy. Ophthalmol Sci. 2023 Mar; 3(1): 100228.