Assistive Robotically Aligning Optical Coherence Tomography and Laser Photocoagulation Therapy of the Retinal Periphery

辅助机器人对准视网膜周边光学相干断层扫描和激光光凝治疗

基本信息

  • 批准号:
    10590252
  • 负责人:
  • 金额:
    $ 21.07万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2023
  • 资助国家:
    美国
  • 起止时间:
    2023-02-01 至 2025-01-31
  • 项目状态:
    未结题

项目摘要

PROJECT SUMMARY/ABSTRACT Retinal detachments can cause significant vision loss and frequently begin as small breaks in the peripheral retina (from ocular globe equator to the ora serrata). These breaks allow fluid to enter the sub-retinal space, detaching the retina and leading to retinal ischemia and dysfunction. Laser photocoagulation (LP) therapy can be utilized in the clinic reducing the risk of subsequent detachment tenfold (50% to 5%) but only if breaks are detected early and before excess fluid has accumulated under the retina. The long-term goal is to develop a system that provides 360° visualization of the peripheral retina replacing the current standard of care for evaluation of the retinal periphery for breaks: indirect ophthalmoscopy with scleral depression, a procedure requiring the examiner to mechanically indent the eye at multiple locations and use an indirect ophthalmoscope and condensing lens to attempt to visualize the retina peripherally and over 360°. The rationale for this project is that in addition to being extremely uncomfortable for the patient, this technique requires considerable skill with specialized training. Furthermore, the exam does not create a direct record of the findings – the examiner must illustrate a guide map from memory for subsequent LP therapy utilizing this same manual technique. These objectives will be achieved by pursuing two specific aims: 1) Adapt a custom conical mirror contact lens and robotically aligning platform to optically access the peripheral retina with OCT and laser photocoagulation therapy; and 2) Validate peripheral retina robotically aligning OCT against scleral depressed exam in eyes with and without peripheral retinal breaks requiring treatment. Under the first aim the conical mirror contact lens and robotically aligning platform will be redesigned to deliver both OCT and LP therapy light to the peripheral retina. The system will be validated for field-of-view and resolution and evaluated for the ability to deliver LP therapy in ex vivo porcine eyes to created breaks throughout the peripheral retinal with real-time OCT image guidance. Under the second aim, the robotically aligning OCT imaging system will be used in vivo. First a pilot study will be performed on healthy subjects optimizing for robot-operator interactions. Upon completion, a powered study will test the null hypothesis that there is no difference between paired differences in the number of breaks per eye as observed by peripheral retina RAOCT versus clinical exam in eyes with and without peripheral retinal breaks requiring treatment. The proposed research is technically innovative, in the applicant’s opinion, because it directly addresses optical issues for accessing and aligning to the retinal periphery by using a custom conical mirror contact designed for use with OCT and LP therapy coupled with 3D tracking and compensation. The proposed research is further clinically innovative, in the applicant’s opinion, because it provides the first 360° comprehensive assessment of the peripheral retina. This is a direct path to provide real- time image guided LP therapy to the full retinal periphery.
项目摘要/摘要 视网膜脱离可导致显著的视力丧失,并且经常开始为视网膜中的小破裂。 周边视网膜(从眼的地球仪赤道到锯齿缘)。这些裂口使液体进入视网膜下 间隙,使视网膜脱离并导致视网膜缺血和功能障碍。激光光凝(LP) 在临床上可以使用这种疗法,将随后的脱离风险降低十倍(50%至5%),但前提是 在视网膜下积聚过多的液体之前,可以早期检测到破裂。长期目标是 开发一种系统,提供周边视网膜的360°可视化,取代当前的护理标准 用于评价视网膜周边裂孔:巩膜凹陷间接检眼镜检查, 要求检查者在多个位置机械地检查眼睛并使用间接检眼镜 以及聚光透镜,以试图在周边和360°上观察视网膜。该项目的基本原理 除了对病人来说非常不舒服之外,这项技术还需要相当高的技巧, 接受过专门训练此外,考试并不直接记录结果-考官 必须从存储器中示出用于利用该相同手动技术的后续LP治疗的引导图。 这些目标将通过追求两个具体目标来实现:1)采用定制的圆锥镜接触透镜 以及机器人对准平台,以利用OCT和激光光凝术光学地接近周边视网膜 治疗;和2)在患有以下疾病的眼睛中,将OCT与巩膜凹陷检查自动对齐, 并且没有需要治疗的周边视网膜破裂。在第一瞄准下,圆锥反射镜接触透镜, 将重新设计机器人对准平台,以将OCT和LP治疗光输送到周边视网膜。 将对系统的视场和分辨率进行确认,并评价其提供LP治疗的能力 在离体猪眼中,利用实时OCT图像引导在整个周边视网膜上产生破裂。 在第二个目标下,机器人对准OCT成像系统将在体内使用。首先,一项试点研究将 在健康受试者身上进行,优化机器人-操作员交互。研究完成后, 将检验零假设,即每例患者的断裂数的配对差异之间没有差异。 通过周边视网膜RAOCT观察的眼睛与有和无周边视网膜RAOCT的眼睛中的临床检查 需要治疗的中断。申请人认为,拟议的研究在技术上是创新的, 因为它直接解决了光学问题, 定制圆锥镜触点,设计用于OCT和LP治疗,结合3D跟踪, 赔偿申请人认为,拟议的研究在临床上具有进一步的创新性,因为它 首次提供周边视网膜的360°全面评估。这是一个直接的途径,提供真实的- 时间图像引导LP治疗到整个视网膜周边。

项目成果

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