目的:患有无法治愈的角膜疾病的患者尽管有健康的视网膜和光学通路,但仍有视觉障碍。规定低视力辅助(LVA)通过放大和对比度增强来优化剩余视力的使用,但不要充分利用病人的视觉能力,因为他们依赖于光学媒体。因此,我们研究了一种绕过眼前节的新型激光眼镜(LEW)技术.由集成相机捕获的图像使用低能量I-RGB类激光直接投影到视网膜上。患者能够观看全彩视频,实现为增强现实。我们旨在评估LEW增强角膜疾病患者视力的疗效。
方法:前瞻性,随机化,交叉临床试验。
方法:我们检查了21名因角膜疾病导致视力障碍(0.7logMAR或更差)的受试者(年龄25-69岁)的视网膜投影眼镜。患有影响视力的合并症的受试者,比如视网膜疾病,被排除在外。
方法:使用ETDRS图分别进行最佳矫正(BC)和LEW,对近距(NV)和远距(DV)的视敏度进行标准化测量。除了阅读速度,在使用和不使用该设备的家庭阶段后,在初次访问和随后的两次访问中评估了与视觉相关的生活质量(QoL)和执行日常任务的能力。最后一次使用LEW6周后,进行包括SD-OCT或全场视网膜电图在内的眼科检查,并与基线进行比较,以评估装置的安全性。四名受试者参与并完成了随后的12个月随访阶段。
方法:使用LEW改善视力。次要目标包括安全,阅读速度,日常活动中的QoL和可用性。
结果:与BC相比,使用LEW的DV中视力障碍受试者的平均视敏度(VA)提高了0.43logMAR(p<0.0001)。使用LEW的2x放大模式导致与BC相比0.66logMAR的平均改善(p<0.0001)。在NV中,与BC相比实现了0.47logMAR的增加(p<0.0001)。虽然21名参与者中只有4名能够阅读BC,17/21能够阅读LEW。完成所有访问的17名受试者的QoL显着改善。
结论:我们证明了视网膜投影眼镜通过直接将图像投射到完整的视网膜上,可以提高所有受试者的视力。在未来,LEW可以代表角膜疾病患者作为LVA的新供应选择。
OBJECTIVE: Patients with incurable corneal diseases experience visual impairment (VI) despite having a healthy retina and optic pathway. Low-vision aids (LVAs) can optimize the use of remaining vision through magnification and contrast enhancement, but do not harness the full visual capacity because they rely on the optic media. Therefore, we investigated a novel laser eyewear (LEW) technology that bypasses the anterior segment of the eye. Images captured by an integrated camera are projected directly onto the retina using a low-energy laser. The patient is able to view a full-color video, realized as augmented reality. We aimed to evaluate the efficacy of the LEW to enhance the vision of individuals with corneal diseases.
METHODS: Prospective, randomized, crossover clinical
trial.
METHODS: We examined the retinal projection glasses in 21 patients (25-69 years) with VI (0.7 logarithm of the minimum angle of resolution [logMAR] or worse) resulting from corneal diseases. Patients with comorbidities that impact vision, such as retinal disorders, were excluded.
METHODS: Standardized measurements of visual acuity (VA) for near vision (NV) and distance vision (DV) were conducted using ETDRS charts with the respective best correction (BC) and then with LEW. In addition reading speed, vision-related quality of life (QoL) and capacity to carry out daily tasks were assessed at an initial visit and at 2 subsequent visits after a home phase with and without the device. Six weeks after last use of the LEW, an ophthalmologic examination including spectral-domain-OCT or full-field-electroretinography was conducted and compared with baseline findings to evaluate the safety of the device. Four patients participated and completed a subsequent 12-month follow-up phase.
METHODS: Improvement of VA using the LEW. Secondary objectives included safety, reading speed, QoL, and usability in daily activities.
RESULTS: The mean VA in patients with VI was improved by 0.43 logMAR in DV using the LEW compared with BC (P < 0.0001). Using the ×2 magnification mode of the LEW resulted in an average improvement of 0.66 logMAR compared with BC (P < 0.0001). In NV, an increase of 0.47 logMAR was achieved compared with BC (P < 0.0001). Although only 4 of 21 participants were able to read with BC, 17 of 21 participants were able to read with the LEW. Quality of life significantly improved in the 17 participants who completed all visits.
CONCLUSIONS: We demonstrated that the retinal projection glasses resulted in enhanced VA for all participants by directly projecting images onto the intact retina. In future, the LEW could represent a new option as an LVA for patients with corneal diseases. No pathological alterations were observed in the safety assessments.
BACKGROUND: The author(s) have no proprietary or commercial interest in any materials discussed in this article.