What Akoya has observed—and what still requires evaluation.
Preliminary patient-reported feedback is presented separately from published literature that informed the product concept. The cited studies did not evaluate Akoya Eye Shield.
Breast-biopsy setting: 45 completed questionnaires among 50 patients.
This was an initial post-use questionnaire set. It was not randomized, controlled, or designed to establish clinical effectiveness.
Patient-reported experience ratings
The original feedback summary reported the percentages below from a questionnaire using a 1-to-5 experience scale, where 1 represented very difficult and 5 represented very easy.
| Category | Reported rate |
|---|---|
| Ease of Use | 96% |
| Reliability | 98% |
| Comfort | 96% |
| Recommendation | 96% |
| Anxiety Relief | 88% |
Patient comments
“I couldn’t have done the procedure without them!”
“I passed out during a previous biopsy but didn’t this time.”
These comments describe individual patient experiences and do not establish causation or typical outcomes.
Reporting note: These percentages are reproduced from Akoya’s original feedback summary. Exact item wording, item-level response counts, and the calculation method for each reported rate have not yet been published.
Interpretation limitation: This was descriptive feedback from a limited questionnaire set, not a controlled clinical study. It does not establish causation, clinical effectiveness, or expected results in oncology or infusion care.
Published research that informed the design rationale.
The studies below examined looking behavior, virtual-reality interventions, fear, anxiety, or vasovagal reactions in populations and interventions different from Akoya Eye Shield. They should not be interpreted as evidence that Akoya produces the same outcomes.
Looking toward or away from a needle
A pilot randomized vaccination study reported higher fear among adults assigned to look at the needle than among adults assigned to look away, without evidence of a difference in pain. The authors characterized the findings as preliminary and recommended a larger trial.
Reference
Mithal P, Simmons P, Cornelissen T, et al. To look or not to look during vaccination: A pilot randomized trial. Canadian Journal of Pain. 2018;2(1):1-8. DOI: 10.1080/24740527.2017.1412254.
View the verified PubMed recordNeedle fear in adults with chronic disease
A scoping review of 32 papers reported widely varying needle-fear prevalence estimates across chronic-disease cohorts, including 17%–52% in cancer cohorts and 25%–47% in chronic kidney disease cohorts. Assessment methods varied, and the authors found limited evidence supporting management strategies.
Interpretation: These ranges do not estimate how many patients would choose or benefit from Akoya Eye Shield, and the review did not evaluate the product.
Reference
Duncanson E, Le Leu RK, Shanahan L, et al. The prevalence and evidence-based management of needle fear in adults with chronic disease: A scoping review. PLoS One. 2021;16(6):e0253048. DOI: 10.1371/journal.pone.0253048.
View the verified PubMed recordVirtual technology and fear of medical procedures
A systematic review considered virtual-reality-based interventions for fear of medical procedures. Virtual reality is a different intervention from Akoya Eye Shield, and results from that literature cannot be attributed to this product.
Reference
Kilic A, Brown A, Aras I, et al. Using Virtual Technology for Fear of Medical Procedures: A Systematic Review of the Effectiveness of Virtual Reality-Based Interventions. Annals of Behavioral Medicine. 2021;55(11):1062-1079. DOI: 10.1093/abm/kaab016.
View the verified PubMed recordVirtual reality in pediatric procedures
A systematic review and meta-analysis evaluated immersive virtual reality for pain and anxiety in pediatric medical procedures. The population and intervention differ materially from Akoya Eye Shield.
Reference
Eijlers R, Utens EMWJ, Staals LM, et al. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesthesia & Analgesia. 2019;129(5):1344-1353. DOI: 10.1213/ANE.0000000000004165.
View the verified PubMed recordVasovagal reactions in interventional pain procedures
A review discussed the pathophysiology, incidence, risk factors, prevention, and management of vasovagal reactions in interventional pain procedures. It noted limited research and conflicting preventive guidance. It did not evaluate Akoya Eye Shield.
Reference
Malave B, Vrooman B. Vasovagal Reactions during Interventional Pain Management Procedures—A Review of Pathophysiology, Incidence, Risk Factors, Prevention, and Management. Medical Sciences. 2022;10(3):39. DOI: 10.3390/medsci10030039.
View the verified PubMed recordPublished context on the scale of relevant care settings.
These sources describe healthcare activity. They do not indicate how many patients need, would choose, or would benefit from Akoya Eye Shield, and they are not used here as product-effectiveness evidence.
Ambulatory chemotherapy visits
An AHRQ-supported final project report estimated 23 million annual adult chemotherapy visits in the United States, with 19 million (84%) in ambulatory settings. The report focused on communication, technology use, and patient safety in ambulatory oncology; it did not evaluate Akoya Eye Shield.
Reference
Friese CR. Communication Processes, Technology, and Patient Safety in Ambulatory Oncology Settings. Final Progress Report. AHRQ grant R01-HS-024914.
View the AHRQ-supported reportRecent breast-biopsy follow-up study
A 2025 single-institution study of 432 patients with breast atypia notes in its background that more than one million women undergo breast biopsies annually in the United States. That national-volume statement is cited background, not a new national estimate produced by the study. The study focused on repeat biopsies after an atypia diagnosis and did not evaluate Akoya Eye Shield.
Reference
Dalton JC, Thomas SM, Chiba A, Wang T, Hwang ES, Plichta JK. Subsequent percutaneous breast biopsies after initial atypia diagnosis: The patient burden of long-term follow up. American Journal of Surgery. 2025;239:115993. DOI: 10.1016/j.amjsurg.2024.115993.
View the verified PubMed recordHistorical breast-biopsy utilization
A claims-based analysis using 2011–2015 commercial and Medicare Supplemental data projected approximately 1.59 million breast-biopsy procedures annually in the United States. This is a historical projection rather than a current procedure count, and the study did not evaluate Akoya Eye Shield.
Funding and affiliation disclosure: Three authors were employees of Truven Health Analytics, which was paid by Seno Medical Instruments in connection with the paper; another author was a Seno employee.
Reference
Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of utilization patterns and associated costs of the breast imaging and diagnostic procedures after screening mammography. ClinicoEconomics and Outcomes Research. 2018;10:157-167. DOI: 10.2147/CEOR.S150260.
View the verified PubMed recordLimit lower-field visibility while leaving an upper viewing area open.
That physical mechanism—not a promised clinical outcome—is the central design premise of Akoya Eye Shield. Fit, positioning, facial anatomy, and gaze direction can affect the amount of visual obstruction.