Yoon Michael K, Aakalu Vinay K, Dagi Glass Lora R, Grob Seanna R, McCulley Timothy J, Vagefi M Reza, Pineles Stacy L, Wladis Edward J
Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts; Ophthalmic Plastic Surgery Service, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts.
Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor, Michigan.
Ophthalmology. 2025 Aug;132(8):945-953. doi: 10.1016/j.ophtha.2025.03.006. Epub 2025 May 3.
To review systematically the literature on the efficacy and safety of the use of patient-specific implants (PSIs) in orbital reconstructive surgery.
A literature search was last conducted in January 2025 in the PubMed database for English language original research that assessed the use of any PSI reported for orbital reconstructive surgery. Of the 219 articles identified, 51 met the inclusion criteria for this assessment and were selected for full-text review and data abstraction. A total of 19 studies met the study criteria, and the panel methodologist assigned a level III rating to each study.
No study met the criteria for level I or II evidence. Eight of the 19 studies compared a PSI group with a control group (other forms of implants such as preformed, prebent sheets)-5 studies involved acute fracture repair and 3 involved a mixture of acute, delayed, or revision surgery. The remaining 11 studies did not have a comparison group, and indications included acute fracture repair (n = 2), delayed or secondary fracture repair (n = 3), or an after-tumor resection (n = 5). One study compared outcomes using PSIs designed using automated software with PSIs designed manually. Patient-specific implant material included titanium (n = 12), polyether ether ketone (PEEK) (n = 3), porous polyethylene (n = 2), and ceramic (n = 2). Time to manufacture implants ranged from 1 to 35 days, with most under 10 days. Volumetric analysis generally reported greater improvement in postoperative orbital volume for PSIs compared with non-PSIs. Clinical improvement in diplopia, enophthalmos, and extraocular motility was variably reported and largely not statistically analyzed or significant. Complications were variably reported and included expected complications after orbital fracture repair.
The existing literature on PSIs for orbital surgery contains a heterogeneity of indications, designs, materials, and reporting. Because all studies met level III criteria for evidence, definitive conclusions were limited. Although anecdotal and low-quality evidence reports showed possible improved outcomes with PSIs compared with non-PSIs, determination of the best applications, designs, outcomes, and safety will require well-designed prospective studies with sufficient postoperative follow-up and outcome metrics.
FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.
系统回顾关于个性化植入物（PSI）在眼眶重建手术中疗效和安全性的文献。
2025年1月在PubMed数据库中进行了一次文献检索，以查找评估用于眼眶重建手术的任何PSI的英文原创研究。在识别出的219篇文章中，51篇符合本次评估的纳入标准，被选出来进行全文审查和数据提取。共有19项研究符合研究标准，小组方法学家给每项研究评定为III级。
没有研究符合I级或II级证据标准。19项研究中的8项将PSI组与对照组（其他形式的植入物，如预制的、预弯的板材）进行了比较——5项研究涉及急性骨折修复，3项研究涉及急性、延迟或翻修手术的混合情况。其余11项研究没有对照组，适应证包括急性骨折修复（n = 2）、延迟或二次骨折修复（n = 3）或肿瘤切除术后（n = 5）。一项研究比较了使用自动软件设计的PSI与手动设计的PSI的结果。个性化植入物材料包括钛（n = 12）、聚醚醚酮（PEEK）（n = 3）、多孔聚乙烯（n = 2）和陶瓷（n = 2）。植入物制造时间为1至35天，大多数在10天以内。体积分析通常报告，与非PSI相比，PSI术后眼眶体积改善更大。关于复视、眼球内陷和眼球运动的临床改善情况报告不一，且大多未进行统计学分析或无显著差异。并发症报告不一，包括眼眶骨折修复后的预期并发症。
关于用于眼眶手术的PSI的现有文献在适应证、设计、材料和报告方面存在异质性。由于所有研究均符合III级证据标准，确定性结论有限。尽管轶事性和低质量证据报告显示，与非PSI相比，PSI可能有更好的结果，但确定最佳应用、设计、结果和安全性将需要精心设计的前瞻性研究，并进行充分的术后随访和结果指标评估。
作者对本文讨论的任何材料均无所有权或商业利益。
