Background/Objectives: Three-dimensional (3D) heads-up visualization systems are increasingly used in vitreoretinal surgery and may offer advantages in intraoperative visualization, ergonomics, surgical education, and reduced light exposure. This study aimed to compare morphofunctional outcomes, intraoperative parameters, postoperative complications, and surgical team satisfaction between 3D heads-up visualization and standard operating microscopy in idiopathic epiretinal membrane (ERM) surgery. Methods: In this prospective randomized study, 25 eyes of 25 patients with idiopathic ERM were assigned to surgery using either a 3D heads-up visualization system (3D group, n = 13) or a standard operating microscope (SOM group, n = 12). BCVA, CMT, mfERG parameters, intraoperative variables, postoperative OCT-based macular complications, and satisfaction scores were evaluated. No formal sample-size calculation was performed; therefore, all analyses should be interpreted as exploratory and hypothesis-generating. Results: Postoperative BCVA and CMT were not significantly different between the two groups at both 1 and 3 months, suggesting that no major between-group difference was detected in final short-term visual and anatomical outcomes compared with standard operating microscopy in macular surgery. However, the 3D group had significantly worse preoperative BCVA, which may have inflated unadjusted change-score estimates. Therefore, the greater ΔBCVA observed in the 3D group should not be interpreted as evidence of superior efficacy. Conclusions: In idiopathic ERM surgery, 3D heads-up visualization showed no statistically significant difference in final anatomical and visual outcomes compared with standard operating microscopy, while allowing significantly lower endoillumination settings during peeling. The findings support its feasibility as an alternative visualization platform; however, they do not establish superiority, equivalence, or safety because of the exploratory design, small sample size, short follow-up, and baseline imbalances.

Morphofunctional outcomes of 3D heads-up visualization versus standard operating microscopy in idiopathic epiretinal membrane surgery: a prospective randomized study / Iannetti, L., Sampalmieri, L., Speranzini, A., Barba, A., Gharbiya, M., Nebbioso, M., Alisi, L.. - In: JOURNAL OF CLINICAL MEDICINE. - ISSN 2077-0383. - 15:18(2026), pp. 1-13. [10.3390/jcm15187288]

Morphofunctional outcomes of 3D heads-up visualization versus standard operating microscopy in idiopathic epiretinal membrane surgery: a prospective randomized study

Iannetti Ludovico
Primo
Writing – Review & Editing
;
Sampalmieri Lorenzo
Secondo
Methodology
;
Speranzini Alessio
Data Curation
;
Barba Arianna
Writing – Original Draft Preparation
;
Gharbiya Magda
Supervision
;
Nebbioso Marcella
Penultimo
Investigation
;
Alisi Ludovico
Ultimo
Supervision
2026

Abstract

Background/Objectives: Three-dimensional (3D) heads-up visualization systems are increasingly used in vitreoretinal surgery and may offer advantages in intraoperative visualization, ergonomics, surgical education, and reduced light exposure. This study aimed to compare morphofunctional outcomes, intraoperative parameters, postoperative complications, and surgical team satisfaction between 3D heads-up visualization and standard operating microscopy in idiopathic epiretinal membrane (ERM) surgery. Methods: In this prospective randomized study, 25 eyes of 25 patients with idiopathic ERM were assigned to surgery using either a 3D heads-up visualization system (3D group, n = 13) or a standard operating microscope (SOM group, n = 12). BCVA, CMT, mfERG parameters, intraoperative variables, postoperative OCT-based macular complications, and satisfaction scores were evaluated. No formal sample-size calculation was performed; therefore, all analyses should be interpreted as exploratory and hypothesis-generating. Results: Postoperative BCVA and CMT were not significantly different between the two groups at both 1 and 3 months, suggesting that no major between-group difference was detected in final short-term visual and anatomical outcomes compared with standard operating microscopy in macular surgery. However, the 3D group had significantly worse preoperative BCVA, which may have inflated unadjusted change-score estimates. Therefore, the greater ΔBCVA observed in the 3D group should not be interpreted as evidence of superior efficacy. Conclusions: In idiopathic ERM surgery, 3D heads-up visualization showed no statistically significant difference in final anatomical and visual outcomes compared with standard operating microscopy, while allowing significantly lower endoillumination settings during peeling. The findings support its feasibility as an alternative visualization platform; however, they do not establish superiority, equivalence, or safety because of the exploratory design, small sample size, short follow-up, and baseline imbalances.
2026
3D heads-up surgery; NGENUITY; OCT-based macular complications; endoillumination; epiretinal membrane; multifocal electroretinography; pars plana vitrectomy; standard operating microscope; vitreoretinal surgery.
01 Pubblicazione su rivista::01a Articolo in rivista
Morphofunctional outcomes of 3D heads-up visualization versus standard operating microscopy in idiopathic epiretinal membrane surgery: a prospective randomized study / Iannetti, L., Sampalmieri, L., Speranzini, A., Barba, A., Gharbiya, M., Nebbioso, M., Alisi, L.. - In: JOURNAL OF CLINICAL MEDICINE. - ISSN 2077-0383. - 15:18(2026), pp. 1-13. [10.3390/jcm15187288]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1777022
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