Galas Stephen, Copper Lenora L
Johnson & Johnson Vision Care Inc., Jacksonville, FL, USA.
Clin Ophthalmol. 2016 Dec 8;10:2469-2474. doi: 10.2147/OPTH.S105222. eCollection 2016.
To evaluate the individual contributions of pigment colorant and packing solution containing polyvinyl pyrrolidone (PVP) on the oxygen permeability (Dk) of a cosmetic printed etafilcon A daily disposable contact lens packaged with PVP.
The oxygen transport of a contact lens is evaluated through the central optical zone of the lens. Cosmetic printed contact lenses contain pigment colorant in the periphery or mid-periphery of the lens. Therefore, to assess the impact of cosmetic print on oxygen permeability, special lenses need to be produced that contain the colorant within the central optical zone. This technique was used to obtain multiple measurements of nonedge-corrected Dk/t of both the center pigmented lens and its nonpigmented equivalent, using a polarographic measurement described in International Organization for Standardization (ISO) 18369-4:2006(E), and the Dk derived for each measurement is corrected for edge effect. In addition, the edge-corrected Dk values of lenses made from the same monomer batch were measured. The lenses were packaged and autoclaved with and without proprietary technology which embeds PVP in the contact lens during autoclaving. The resulting Dk value of the printed lens material was then used with thickness data to generate true Dk/t profiles for a given lens power.
The edge-corrected Dk of the printed etafilcon A lens with offset pigment colorant was measured to be 19.7×10 (cm/s) (mL O/mL·mmHg) at 35°C. This was within ±20% tolerance range as specified in ISO 18369-2:2012(E) for the edge-corrected Dk of the nonpigmented etafilcon A control lens evaluated during the same session, 19.5×10 (cm/s) (mL O/mL·mmHg). The edge-corrected Dk values of the lenses packaged with PVP (mean 20.1, standard deviation [SD] 0.3) were also within the ±20% tolerance range compared to those packaged without PVP (mean 20.0, SD 0.3).
The pigment colorant and PVP embedded in the contact lens during autoclaving were not found to influence the oxygen permeability of the etafilcon A material.
评估色素着色剂和含有聚乙烯吡咯烷酮（PVP）的包装溶液对用PVP包装的美容印花依他氟康A日抛型隐形眼镜透氧性（Dk）的单独影响。
通过隐形眼镜的中央光学区评估隐形眼镜的氧气传输。美容印花隐形眼镜在镜片周边或中周边含有色素着色剂。因此，为了评估美容印花对透氧性的影响，需要制作在中央光学区内含有着色剂的特殊镜片。使用此技术，通过国际标准化组织（ISO）18369-4:2006(E)中所述的极谱测量法，对中央着色镜片及其未着色对照镜片的非边缘校正Dk/t进行多次测量，并对每次测量得出的Dk进行边缘效应校正。此外，还测量了由同一单体批次制成的镜片的边缘校正Dk值。镜片在有或没有专有技术（即在高压灭菌过程中将PVP嵌入隐形眼镜）的情况下进行包装和高压灭菌。然后将所得印花镜片材料的Dk值与厚度数据一起用于生成给定镜片度数的真实Dk/t曲线。
在35°C下，带有偏移色素着色剂的印花依他氟康A镜片的边缘校正Dk测量值为19.7×10（cm/s）（mL O/mL·mmHg）。这在ISO 18369-2:2012(E)规定的同一测试期间评估的未着色依他氟康A对照镜片边缘校正Dk的±20%公差范围内，即19.5×10（cm/s）（mL O/mL·mmHg）。与未用PVP包装的镜片（平均值20.0，标准差[SD] 0.3）相比，用PVP包装的镜片的边缘校正Dk值（平均值20.1，标准差[SD] 0.3）也在±20%公差范围内。
未发现高压灭菌过程中嵌入隐形眼镜的色素着色剂和PVP会影响依他氟康A材料的透氧性。
