Pre-Senile Cataract Pilot Study using the NASA-NEI Clini

使用 NASA-NEI Clini 进行老年前白内障试点研究

• 批准号: 7322410
• 负责人: Manuel B Datiles
• 金额: --
• 依托单位: NATIONAL EYE INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7322410
• 关键词: Pre; Senile; Cataract; Pilot; Study

We recently developed the new Dynamic Light Scattering (DLS) Clinical device under the NASA-NEI Inter-Agency Agreement, and have used it in several cataract studies on more than 400 patients. We found that the DLS cataract data correlate well with Clinical and Photographic Cataract Grading scales, and that the reproducibility is good, with error rates of less than 5%. We also found that it can detect the earliest molecular changes in lens aging and in cataract formation in patients in vivo, non-invasively. In this pilot longitudinal cataract study, we are using this new DLS clinical device to study 15 patients with early Pre-Senile cataract. These cataracts are morphologically similar to age related cataracts but develop in patients below the age of 55 years of age (hence "Pre-Senile"). The Principal Investigator (MDMD) observed in clinical practice that many of these pre senile cataracts develop rapidly, requiring Cataract/IOL surgery within a year or two. The other eye in most cases develops a similar cataract after the first eye, and therefore may be studied early with this device. This study aims to conduct a longitudinal follow up to detect the earliest lens protein molecular changes that occur in the living eye of these patients as the cataract develops. 15 Patients who developed cataract before 55 years of age, with one of the three main types of cataract - Nuclear, Cortical and Posterior Subcapsular cataracts - were screened, recruited and asked to commit to return every 1-3 months for regular follow up for 2 years or until the cataract is removed surgically. All patients gave full informed consent according to the NEI IRB approved protocol, and were advised that they can withdraw from the study anytime. At each visit, a complete dilated eye examination (including A Scan utrasonography at the initial visit), AREDS Clinical Grading of the cataract, AREDS Lens Photography, and DLS testing were performed. The DLS data is then sent to our collaborators at The NASA-John Glenn Research Center in Cleveland, Ohio (Drs. Rafat Ansari and Kwang Suh) for data analysis. Preliminary results confirm the rapidity of the cataract progression, as a majority of the cataracts have significantly progressed and 8 of the 15 patients have undergone cataract surgery. This type of cataract also undergoes a stage where there is lens epithelial decompensation with edema, apoptosis and scarring of the lens epithelial cell layer. We are currently prforming the complete analysis of the data. This type of lens clinical study has not been possible in the past because no clinical device has been developed to study molecular changes in the lens safely, reproducibly and non-invasively with the lens in-situ, without taking the lens outside of the eye. This pilot study helps to show that the DLS device can now be used for cross sectional and longitudinal studies of cataract in vivo (clinically), including for the measurement of the efficacy of newly developed anti cataract drugs in clinical trials.

我们最近根据NASA-NEI机构间协议开发了新的动态光散射（DLS）临床设备，并将其用于400多名患者的几项白内障研究。我们发现，DLS白内障数据与临床和摄影白内障分级量表相关性良好，并且重现性良好，误差率小于5%。我们还发现，它可以检测最早的分子变化，在透镜老化和白内障形成的患者在体内，非侵入性。 在这项试点纵向白内障研究中，我们使用这种新的DLS临床设备来研究15例早期老年前期白内障患者。这些白内障在形态上与年龄相关性白内障相似，但在55岁以下的患者中发展（因此称为“老年前期”）。主要研究者（MDMD）在临床实践中观察到，许多这些老年前白内障发展迅速，需要在一两年内进行白内障/IOL手术。在大多数情况下，另一只眼睛会在第一只眼睛之后出现类似的白内障，因此可以使用该设备进行早期研究。本研究的目的是进行纵向随访，以检测白内障发生时，这些患者的活眼中发生的最早的透镜蛋白分子变化。 对15名在55岁之前发生白内障的患者进行筛查，招募并要求他们承诺每1-3个月返回一次，定期随访2年或直到白内障手术切除。所有患者均根据NEI IRB批准的方案提供了完全知情同意书，并被告知他们可以随时退出研究。每次访视时，进行完整的散瞳眼检查（包括首次访视时的A扫描超声检查）、白内障的AREDS临床分级、AREDS透镜摄影和DLS测试。DLS数据然后被发送到我们在俄亥俄州克利夫兰的NASA-约翰格伦研究中心的合作者（Rafat Ansari和Kwang Suh博士）进行数据分析。 初步结果证实了白内障进展的迅速性，因为大多数白内障已经显著进展，15名患者中有8名接受了白内障手术。这种类型的白内障还经历了透镜上皮代偿失调的阶段，伴随着透镜上皮细胞层的水肿、细胞凋亡和瘢痕形成。我们目前正在对数据进行全面分析。 这种类型的透镜临床研究在过去是不可能的，因为还没有开发出临床装置来在不将透镜取出眼外的情况下，在原位使用透镜安全地、可再现地和非侵入性地研究透镜中的分子变化。这项初步研究有助于表明，DLS设备现在可以用于体内（临床）白内障的横截面和纵向研究，包括在临床试验中测量新开发的抗白内障药物的疗效。