Phase I trial on robot assisted retinal vein cannulation with ocriplasmin infusion for central retinal vein occlusion
Koen Willekens, Andy Gijbels, J. M. M. Smits, Laurent Schoevaerdts, Johan Blanckaert, Jean H.M. Feyen, Dominiek Reynaerts, Peter Stalmans
Abstract
PURPOSE: To evaluate the safety and feasibility of robot-assisted retinal vein cannulation with Ocriplasmin infusion for central retinal vein occlusion. METHODS: Prospective phase I trial including four patients suffering from central retinal vein occlusion (CRVO). Diagnosis was confirmed by preoperative fluo-angiography and followed by a standard three-port pars plana vitrectomy. Afterwards, a custom-built microneedle was inserted into a branch retinal vein with robotic assistance and infusion of Ocriplasmin started. Primary outcomes were the occurrence of intra-operative complications and success of cannulation. Secondary outcomes were change in visual acuity, central macular thickness (CMT) and venous filling times (VFT) during fluo-angiography two weeks after the intervention. RESULTS: Cannulation with infusion of ocriplasmin was successful in all four eyes with a mean total infusion time of 355 ± 204 seconds (range 120-600 seconds). Best corrected visual acuity (BCVA) remained counting fingers (CF) in case 3 and 4, increased in case 1 from CF to 0.9LogMAR and decreased in case 2 from 0.4 to 1.3 LogMAR. CMT and VFT both showed a trend towards significant decrease comparing preoperative measurements with two weeks postintervention (1061 ± 541 μm versus 477 ± 376 μm, p = 0.068) and 24 ll 4 seconds versus 15 ± 1 seconds, p = 0.068, respectively). In one eye a needle tip broke and could be removed with an endoforceps. There were no other intervention-related complications. CONCLUSION: Robot-assisted retinal vein cannulation is feasible and safe. Local intravenous infusion with Ocriplasmin led to an improved retinal circulation.