Department of Ophthalmology, University of Bonn, Bonn, Germany.
Retina. 2012 Nov-Dec;32(10):2133-40. doi: 10.1097/IAE.0b013e31825699e5.
Ozurdex, a novel dexamethasone (DEX) implant, is released by a drug delivery system into the vitreous cavity. We analyzed the mechanical release aperture of the novel applicator, obtained real-time recordings using a high-speed camera system and performed kinematic analysis of the DEX application.
Experimental study.
: The application of intravitreal DEX implants (6 mm length, 0.46 mm diameter; 700 μg DEX mass, 0.0012 g total implant mass) was recorded by a high-speed camera (500 frames per second) in water (Group A: n = 7) or vitreous (Group B: n = 7) filled tanks. Kinematic analysis calculated the initial muzzle velocity as well as the impact on the retinal surface at approximately 15 mm of the injected drug delivery system implant in both groups. A series of drug delivery system implant positions was obtained and graphically plotted over time.
High-speed real-time recordings revealed that the entire movement of the DEX implant lasted between 28 milliseconds and 55 milliseconds in Group A and 1 millisecond and 7 milliseconds in Group B. The implants moved with a mean muzzle velocity of 820 ± 350 mm/s (±SD, range, 326-1,349 mm/s) in Group A and 817 ± 307 mm/s (±SD, range, 373-1,185 mm/s) in Group B. In both groups, the implant gradually decelerated because of drag force. With greater distances, the velocity of the DEX implant decreased exponentially to a complete stop at 13.9 mm to 24.7 mm in Group A and at 6.4 mm to 8.0 mm in Group B. Five DEX implants in Group A reached a total distance of more than 15 mm, and their calculated mean velocity at a retinal impact of 15 mm was 408 ± 145 mm/s (±SD, range, 322-667 mm/s), and the consecutive normalized energy was 0.55 ± 0.44 J/m (±SD). In Group B, none of the DEX implants reached a total distance of 6 mm or more. An accidental application at an angle of 30 grade and consecutively reduced distance of approximately 6 mm may result in a mean velocity of 844 and mean normalized energy of 0.15 J/m (SD ± 0.47) in a water-filled eye.
The muzzle velocity of DEX implants is approximately 0.8 m/s and decreases exponentially over distance. The drag over time in vitreous is faster than in water. The calculated retinal impact energy does not reach reported damage levels for direct foreign bodies or other projectiles.
Ozurdex 是一种新型地塞米松(DEX)植入物,通过药物输送系统释放到玻璃体腔中。我们分析了新型给药器的机械释放孔,使用高速摄像系统实时记录,并对 DEX 给药的运动学进行了分析。
实验研究。
将 6 毫米长、0.46 毫米直径的玻璃体腔内 DEX 植入物(700μg DEX 质量,0.0012 克总植入物质量)应用于充满水的(A 组:n=7)或玻璃体(B 组:n=7)的水箱中,用高速相机(500 帧/秒)记录。运动学分析计算了两组中注射药物输送系统植入物约 15 毫米处的初始枪口速度以及对视网膜表面的冲击。获得了一系列药物输送系统植入物的位置,并随时间以图形方式绘制。
高速实时记录显示,A 组中整个 DEX 植入物的运动持续时间在 28 毫秒至 55 毫秒之间,B 组中为 1 毫秒至 7 毫秒。植入物以 820±350mm/s(±SD,范围 326-1349mm/s)的平均枪口速度移动,B 组为 817±307mm/s(±SD,范围 373-1185mm/s)。在两组中,由于阻力,植入物逐渐减速。随着距离的增加,DEX 植入物的速度呈指数下降,在 A 组中完全停止在 13.9 毫米至 24.7 毫米处,在 B 组中完全停止在 6.4 毫米至 8.0 毫米处。A 组中的 5 个 DEX 植入物总距离超过 15 毫米,其在视网膜冲击 15 毫米处的计算平均速度为 408±145mm/s(±SD,范围 322-667mm/s),连续归一化能量为 0.55±0.44J/m(±SD)。B 组中没有一个 DEX 植入物达到 6 毫米或更长的总距离。在充满水的眼睛中,以 30 度的角度意外应用,并且连续距离减少约 6 毫米,可能导致平均速度为 844,平均归一化能量为 0.15J/m(SD±0.47)。
DEX 植入物的枪口速度约为 0.8m/s,且随距离呈指数下降。玻璃体中的阻力随时间的推移比在水中更快。计算得出的视网膜冲击能量未达到直接异物或其他射弹报道的损伤水平。