Orbital Patient-Specific (Customized) Implants: A Report by the American Academy of Ophthalmology.

PURPOSE

To review systematically the literature on the efficacy and safety of the use of patient-specific implants (PSIs) in orbital reconstructive surgery.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.