Feasibility of Pediatric Contrast Sensitivity Test

描述(由申请者提供)：这个STTR项目开发和评估了一种新的视觉对比敏感度临床测试，该测试将在婴儿和未受过教育的儿童和成人身上发挥作用。这种条纹卡对比敏感度(SCCS)测试将有助于定量描述患有一系列视觉障碍的患者的视觉功能，在计划和随后的治疗和干预中，在确定残疾的深度，以及在评估新治疗的益处方面。它的潜在市场包括世界各地的眼科医生、验光师和其他眼部护理专家。在第一阶段，将评估SCCS测试的临床可行性，并确定其对临床实践的影响。临床可行性将通过确定它是否可以用于测试儿童的大范围视觉表现来进行，包括正常新生儿和患有低视力和其他障碍的学龄儿童。这将包括评估SCCS测试是否足够可靠，用于临床使用，并通过在年龄较大的低视力儿童身上确定SCCS测试的对比敏感度结果是否与使用对比敏感度测试的“金标准”-佩利-罗布森图表获得的结果一致。这项测试对临床实践的影响将通过检查SCCS测试结果与一份关于视力障碍对患者生活影响的有效问卷的结果之间的关系来研究。 此外，在第一阶段，当局会确定在技术上是否可行，可以将这项测试投入商业用途，售予眼科医生和视光师，让他们在诊所使用。技术工作将开发具体的方法，以生产精确校准和准确的对比度值的SCCS卡，这些卡没有可能产生虚假结果的伪影 临床实践，它足够耐用，可以在多年的使用中保持无伪影，并且对临床医生来说价格合理。第二阶段的计划包括进行年龄正常化和其他测量，以指导临床医生解释单个患者的SCCS测试结果。第三阶段商业化计划包括扩大和生产SCCS测试及其方案，使其可供世界各地的眼科护理专家使用。 公共卫生相关性：该项目开发和评估了一种新的视觉对比敏感度临床测试，该测试将在婴儿、未受过教育的儿童和残疾成年人身上发挥作用。这种条纹卡对比敏感度(SCCS)测试将有助于定量描述患有一系列视觉障碍的患者的视觉功能，在计划和随后的治疗和干预中，在确定残疾的深度，以及在评估新治疗的益处方面。如果成功，这项临床测试将被世界各地的眼科医生、验光师和其他眼科护理专家使用。

DESCRIPTION (provided by applicant): This STTR project develops and assesses a new clinical test of visual contrast sensitivity that will work on infants and uninstructable children nd adults. This Stripe Card Contrast Sensitivity (SCCS) test would be useful in quantitatively describing the visual function of patients with a range of visual disorders, in planning and following treatments and interventions, in determining the depth of disability, and in assessing the benefits of new treatments. Its potential market includes ophthalmologists, optometrists and other eye care specialists around the world. In the Phase-1 year, the clinical feasibility of the SCCS test will be assessed and its impact on clinical practice will be established. The clinical feasibility will be investigated by determining whether it can be used to test children over a larg range of visual performance, including normal newborn infants and school-aged patients with low vision and other handicaps. This will include assessment of whether the SCCS test is reliable enough for clinical use, and by determining, on older low-vision children, whether the contrast sensitivity results for the SCCS test agree with those obtained using the "gold standard" for contrast sensitivity testing, the Pelli- Robson chart. The impact of the test on clinical practice will be studied by examining the relationship between SCCS test results and results of a well-validated questionnaire on the impact of vision impairment on the patient's life. Also in the Phase-1 year, the technical feasibility will be established of producing the SCCS test for commercial sale to ophthalmologists and optometrists who will use it in their clinics. Technical work will develop the specific methods to produce SCCS cards of precisely calibrated and accurate values of contrast, which are free of artifacts that could produce spurious results in clinical practice, which are durable enough to remain artifact-free over many years of use, and which are reasonably priced for the clinician. Plans for Phase-2 include performing age-norming and other measurements that will guide the clinician in interpreting the SCCS test results on an individual patient. Phase-3 commercialization plan includes scaling up and production of the SCCS test and its protocols making it available to eye care specialists around the world. PUBLIC HEALTH RELEVANCE: This project develops and evaluates a new clinical test of visual contrast sensitivity that will work on infants, uninstructable children and handicapped adults. This Stripe Card Contrast Sensitivity (SCCS) test would be useful in quantitatively describing the visual function of patients with a range of visual disorders, in planning and following treatments and interventions, in determining the depth of disability, and in assessing the benefits of new treatments. If it is successful, this clinical test will be used by ophthalmologists, optometrists and other eye care specialists around the world.