Johnson and Johnson Vision Van Swietenlaan 5, Groningen, 9728 NX, The Netherlands.
Eye (Lond). 2024 May;38(Suppl 1):4-8. doi: 10.1038/s41433-024-03041-0. Epub 2024 Apr 5.
The purpose of this study is to evaluate the optical and expected clinical performance of a new refractive Extended Depth of Focus (EDF) intraocular lens (IOL), TECNIS PureSee™ IOL, designed to maintain a monofocal-like dysphotopsia profile.
Simulated visual acuity (sVA) with varying defocus was calculated using the area under the Modulation Transfer Function measured in an average eye model and from computer simulations in eye models with corneal higher-order aberrations. Tolerance to defocus was evaluated using computer simulations of the uncorrected distance sVA under defocus. To evaluate the dysphotopsia profile, halo pictures obtained using an IOL-telescope, as well as simulated images in a realistic eye model under defocus were assessed. The results of the refractive EDF were compared to those of a diffractive EDF of the same platform.
The refractive EDF IOL provides similar range of vision to the diffractive EDF IOL with the same distance, and similar intermediate and near sVA. The refractive EDF IOL provides the same tolerance to hyperopia as the diffractive EDF but more tolerance to myopia. Halo pictures and simulations showed that the refractive EDF provides comparable dysphotopsia profile to the monofocal IOL and better than the diffractive EDF.
The results of this preclinical study in clinically relevant conditions show that the new refractive EDF IOL is expected to provide similar range of vision to the diffractive IOL of the same platform and higher tolerance to refractive errors. The refractive EDF provides a dysphotopsia profile that is better than the diffractive EDF and comparable to that of the monofocal IOL, also in the presence of residual refractive errors.
本研究旨在评估一种新型折射型扩展景深（EDF）人工晶状体（IOL）——TECNIS PureSee™ IOL 的光学性能和预期临床效果，该人工晶状体旨在保持类似于单焦点的视觉像差特性。
在平均眼模型中通过测量调制传递函数的面积，以及在具有角膜高阶像差的眼模型中通过计算机模拟，计算出不同离焦状态下的模拟视敏度（sVA）。通过在未矫正的离焦状态下模拟计算无镜距离 sVA，评估对离焦的容忍度。为了评估视觉像差特性，使用 IOL 望远镜获得晕环图，并在离焦下的真实眼模型中模拟图像进行评估。将折射型 EDF 的结果与同一平台的衍射型 EDF 进行比较。
折射型 EDF IOL 提供了与具有相同远距视力的衍射型 EDF IOL 相似的视力范围，以及相似的中间和近距 sVA。折射型 EDF IOL 对远视的容忍度与衍射型 EDF 相同，但对近视的容忍度更高。晕环图和模拟结果表明，折射型 EDF 提供了与单焦点 IOL 相当的视觉像差特性，优于衍射型 EDF。
在临床相关条件下的这项临床前研究结果表明，新型折射型 EDF IOL 有望提供与同一平台的衍射型 IOL 相似的视力范围，并且对屈光误差的容忍度更高。折射型 EDF 提供的视觉像差特性优于衍射型 EDF，与单焦点 IOL 相当，即使存在残余屈光误差。
