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.
Diamond dust particles were identified within patients' eyes both during vitrectomy procedures using diamond-dusted membrane scrapers and in postoperative clinical examinations. The particles had no impact on the patients' vision and caused no apparent sequelae. Scanning electron microscopy analysis showed the average particle size to be 23.4 μm and an unequal surface area for particle adhesion onto the soft tip. It was determined that diamond dust particles can dislodge from the silicone tip of the Tano diamond-dusted membrane scrapers during the insertion into valve trocars throughout vitrectomy operations and deposit on the retinal surface or within macular holes. Ophthalmologists should be aware of residual diamond particles during procedures and consider diamond dust retinopathy in the differential diagnosis of crystalline retinopathies. Understanding the appearance of residual particles on the retina allows for future studies revealing the long-term impact on patient's visual performance.
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