PURPOSE: To assess safety, efficacy, and outcomes of vitreoretinal surgery for macular pathology using a 3-dimensional heads-up display (3D HUD) surgical platform compared with a standard operating microscope (SOM). DESIGN: Prospective, single-center, unmasked, randomized study. PARTICIPANTS: Patients undergoingpars plana vitrectomy (PPV) for epiretinal membrane (ERM) or full-thickness macular hole (MH) at Wills Eye Hospital. METHODS: Patients were randomized 1:1 to undergo surgery with a 3D HUD surgical platform or SOM. Patients who had previous PPV were excluded. Surgical choices, including PPV gauge, were based on surgeon preference. Standard surgical safety parameters, Early Treatment Diabetic Retinopathy Study visual acuity (VA), minimum required endoillumination levels, operative times, and surgeon "ease of use" of the viewing platform were recorded. Patients were followed up to postoperative month 3 (POM3). MAIN OUTCOME MEASURES: The main outcome measures were total operative time, macular peel time, surgeon rating of viewing system ease of use, minimum required endoillumination, intraoperative complication rate, and postoperative VA. RESULTS:Thirty-nine eyes of 39 patients with a mean age of 67.60±8.21 SD years were enrolled. Indications included ERM (n = 26 [3D HUD = 14, SOM = 12]) and MH (n = 13 [3D HUD = 9, SOM = 4]). Minimum required endoillumination was significantly lower with 3D HUD (mean 22.70%±15.10% SD) compared with SOM (mean 39.06%±2.72%; P < 0.001). There was no significant difference in overall operative time, but macular peel time was significantly longer using 3D HUD (mean 14.76±4.79 minutes) than SOM (11.87±8.07 minutes; P = 0.004). Surgeon-reported ease of use was significantly higher (easier) using SOM compared with 3D HUD (P = 0.004). There was no statistically significant difference between the groups in POM3 logarithm of the minimum angle of resolution (logMAR) VA or change in logMAR VA from baseline (all P > 0.681). There were no clinically significant intraoperative complications in either group. CONCLUSIONS: Three-dimensional heads-up display surgical visualization is an evolving technology demonstrating comparable efficacy to the SOM for macular surgery. Although overall surgical times were similar, 3D HUD macular peel times were longer and associated with less ease of use in this study, which may partly be due to a learning curve with new technology.
RCT Entities:
PURPOSE: To assess safety, efficacy, and outcomes of vitreoretinal surgery for macular pathology using a 3-dimensional heads-up display (3D HUD) surgical platform compared with a standard operating microscope (SOM). DESIGN: Prospective, single-center, unmasked, randomized study. PARTICIPANTS: Patients undergoing pars plana vitrectomy (PPV) for epiretinal membrane (ERM) or full-thickness macular hole (MH) at Wills Eye Hospital. METHODS:Patients were randomized 1:1 to undergo surgery with a 3D HUD surgical platform or SOM. Patients who had previous PPV were excluded. Surgical choices, including PPV gauge, were based on surgeon preference. Standard surgical safety parameters, Early Treatment Diabetic Retinopathy Study visual acuity (VA), minimum required endoillumination levels, operative times, and surgeon "ease of use" of the viewing platform were recorded. Patients were followed up to postoperative month 3 (POM3). MAIN OUTCOME MEASURES: The main outcome measures were total operative time, macular peel time, surgeon rating of viewing system ease of use, minimum required endoillumination, intraoperative complication rate, and postoperative VA. RESULTS: Thirty-nine eyes of 39 patients with a mean age of 67.60±8.21 SD years were enrolled. Indications included ERM (n = 26 [3D HUD = 14, SOM = 12]) and MH (n = 13 [3D HUD = 9, SOM = 4]). Minimum required endoillumination was significantly lower with 3D HUD (mean 22.70%±15.10% SD) compared with SOM (mean 39.06%±2.72%; P < 0.001). There was no significant difference in overall operative time, but macular peel time was significantly longer using 3D HUD (mean 14.76±4.79 minutes) than SOM (11.87±8.07 minutes; P = 0.004). Surgeon-reported ease of use was significantly higher (easier) using SOM compared with 3D HUD (P = 0.004). There was no statistically significant difference between the groups in POM3 logarithm of the minimum angle of resolution (logMAR) VA or change in logMAR VA from baseline (all P > 0.681). There were no clinically significant intraoperative complications in either group. CONCLUSIONS: Three-dimensional heads-up display surgical visualization is an evolving technology demonstrating comparable efficacy to the SOM for macular surgery. Although overall surgical times were similar, 3D HUD macular peel times were longer and associated with less ease of use in this study, which may partly be due to a learning curve with new technology.
Authors: Ben Asani; Jakob Siedlecki; Benedikt Schworm; Wolfgang J Mayer; Thomas C Kreutzer; Nikolaus Luft; Siegfried G Priglinger Journal: Front Med (Lausanne) Date: 2020-12-22