Hickson-Curran S B, Nason R J, Becherer P D, Davis R A, Pfeifer J, Stiegemeier M J
Vistakon Clinical Research, Jacksonville, Florida, USA.
Optom Vis Sci. 1997 Aug;74(8):632-8. doi: 10.1097/00006324-199708000-00024.
In response to increasing scientific evidence which indicates that ultraviolet radiation (UVR) is a potential threat to ocular health, Acuvue contact lenses (Vistakon, Johnson & Johnson Vision Products Inc., Jacksonville, Florida) have been developed which incorporate an ultraviolet (UV) blocker within the lens polymer. Data are presented for the first clinical evaluation of Acuvue lenses with UV blocking characteristics.
A double-masked, multicenter, prospective clinical trial involving 94 subjects was conducted. The study followed a randomized, parallel group design and consisted of 3 months of daily wear with two-weekly lens replacement. Two thirds of the subjects (61) wore the test lenses (Acuvue with UV blocker) and the remaining subjects (33) wore conventional Acuvue lenses (without UV blocker).
Biomicroscopic evaluations indicated that the performance of the test and control lenses was clinically similar. No clinically relevant differences between the test and control lenses were noted in the subjective assessments of vision, comfort, or handling. In addition, no differences were shown for surface deposition, lens durability, visual acuity, and subjective symptoms.
The study findings indicate that the addition of a UV blocker to Acuvue contact lenses has been achieved without affecting daily wear clinical performance. Because there is increasing evidence to suggest that the ocular tissues may be damaged by UVR, it is prudent for eye care practitioners to prescribe contact lenses that offer the benefits of both regular replacement and UV protection.
越来越多的科学证据表明紫外线辐射（UVR）对眼部健康构成潜在威胁，为此研发了酷柏隐形眼镜（美国佛罗里达州杰克逊维尔市强生视力健公司生产），该镜片在聚合物中添加了紫外线（UV）阻滞剂。本文首次给出了具有紫外线阻挡特性的酷柏隐形眼镜的临床评估数据。
开展了一项涉及94名受试者的双盲、多中心、前瞻性临床试验。该研究采用随机平行组设计，为期3个月，每日佩戴，每两周更换一次镜片。三分之二的受试者（61名）佩戴测试镜片（含紫外线阻滞剂的酷柏隐形眼镜），其余受试者（33名）佩戴传统酷柏隐形眼镜（不含紫外线阻滞剂）。
生物显微镜评估表明，测试镜片和对照镜片的性能在临床上相似。在视力、舒适度或佩戴体验的主观评估中，未发现测试镜片和对照镜片之间存在临床相关差异。此外，在表面沉积物、镜片耐用性、视力和主观症状方面也未显示出差异。
研究结果表明，在酷柏隐形眼镜中添加紫外线阻滞剂不会影响其日常佩戴的临床表现。鉴于越来越多的证据表明眼部组织可能会受到紫外线辐射的损害，眼科护理从业者明智的做法是开具既具有定期更换优势又能提供紫外线防护的隐形眼镜处方。
