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FIRST-IN-HUMAN CLINICAL STUDY TO INVESTIGATE THE EFFECTIVENESS AND SAFETY OF PARS PLANA VITRECTOMY SURGERY USING A NEW HYPERSONIC TECHNOLOGY

Stanga, Paulo E., MD*,†,‡; Williams, Jon I., PhD§; Shaarawy, Sherif A., MRCSEd (Ophth)*,†,¶; Agarwal, Amar, FRCS**; Venkataraman, Anusha, FRCS**; Kumar, Dhivya A., FRCS**; You, Timothy T., MD††; Hope, Richard S., MD‡‡

doi: 10.1097/IAE.0000000000002365
Original Study: PDF Only

Purpose: Investigate the effective performance and safety of a new hypersonic vitrector technology.

Methods: Postapproval, prospective, single-arm, noncomparative, open-label study at one clinical site in India. Indications: macular hole (9/20), vitreous hemorrhage (7/20), vitreomacular traction (3/20), and vitreomacular traction with pseudomacular hole (1/20). Safety endpoints included intraoperative and postoperative adverse events. Effective performance endpoints were surgeon-rated effectiveness, range of surgical time, and device settings. Other performance measures were preoperative and postoperative best-corrected visual acuity, slit-lamp and indirect ophthalmoscopy, applanation tonometry, color fundus photography, fundus fluorescein angiography, and spectral domain optical coherence tomography.

Results: Core vitreous removal (20/20 subjects), peripheral vitreous removal (18/20), and posterior vitreous detachment induction (13/15) surgeries were successfully completed. Total surgical time was 22.5 minutes to 106 minutes. Serious adverse events through 3 months were 2 device-associated retinal tears and detachment (one intraoperative) and one unrelated postoperative enlargement of macular hole with subretinal fluid.

Conclusion: This first-in-human study suggests that this new hypersonic vitrector technology is a promising alternative to commercially available guillotine vitrectors. The hypersonic vitrector was effective in core vitreous removal in all cases. Larger-scale studies are required to expand on our initial findings for induction of a posterior vitreous detachment or peripheral vitrectomy.

This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial License 4.0 (CCBY-NC), where it is permissible to download, share, remix, transform, and buildup the work provided it is properly cited. The work cannot be used commercially without permission from the journal.

This is a first-in-human study using a new hypersonic vitrectomy technology, a promising new alternative to the currently commercially available guillotine vitrectors. This study shows the initial experience in humans and highlights potential benefits in various vitreoretinal surgical scenarios.

*Manchester Academic Health Science Centre, Manchester Royal Eye Hospital, Manchester University NHS Foundation Trust, Manchester, United Kingdom;

Manchester Vision Regeneration Lab, Manchester Academic Health Science Centre, Manchester University NHS Foundation Trust, Manchester, United Kingdom;

Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom;

§Bausch Health Companies, Irvine, California;

Alexandria University, Alexandria, Egypt;

**Dr Agarwal's Eye Hospital and Eye Research Centre, Chennai, India;

††Orange County Retina Medical Group, Laguna Hills, California; and

‡‡Bausch & Lomb, Inc, Irvine, California.

Reprint requests: Paulo E. Stanga, MD, Manchester Academic Health Science Centre, Manchester Royal Eye Hospital, Manchester University NHS Foundation Trust, Manchester, United Kingdom; e-mail: p.stanga@retinaspecialist.co.uk

Supported by Bausch & Lomb Inc, St. Louis, MO.

P. E. Stanga received consulting fee, honorarium, support for travel to meetings for the study or other purposes, payment for setting up and leading the study and writing the manuscript and fees for participation in review activities. A. Agarwal was contracted through Bausch and Lomb to conduct the study at the institution in India. J. I. Williams is an employee at Bausch Health Companies, Irvine, CA. T. T. You is a consultant for Bausch & Lomb, Inc, Irvine, CA. R. S. Hope is an employee at Bausch & Lomb, Inc, Irvine, CA. The remaining authors have no financial/conflicting interests to disclose.

This study was completed as a collaboration between University of Manchester, Manchester, United Kingdom, and Dr Agarwal's Eye Hospital and Eye Research Centre, Chennai, India.

© 2018 by Ophthalmic Communications Society, Inc.