Phase I trial on robot assisted retinal vein cannulation with ocriplasmin infusion for central retinal vein occlusion

Acta Ophthalmol. 2021 Feb;99(1):90-96. doi: 10.1111/aos.14480. Epub 2020 Jul 23.

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.

Keywords: ocriplasmin; retinal endovascular surgery; retinal vein cannulation; retinal vein occlusion; robot-assisted intraocular surgery.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Catheterization / methods*
  • Female
  • Fibrinolysin / administration & dosage*
  • Fluorescein Angiography
  • Follow-Up Studies
  • Fundus Oculi
  • Humans
  • Infusions, Intravenous
  • Male
  • Middle Aged
  • Peptide Fragments / administration & dosage*
  • Prospective Studies
  • Retinal Vein
  • Retinal Vein Occlusion / diagnosis
  • Retinal Vein Occlusion / drug therapy*
  • Robotics / methods*
  • Tomography, Optical Coherence
  • Treatment Outcome
  • Visual Acuity*
  • Vitrectomy / methods*

Substances

  • Peptide Fragments
  • microplasmin
  • Fibrinolysin