Retina (Philadelphia, Pa.) · 2020
FIRST-IN-HUMAN CLINICAL STUDY TO INVESTIGATE THE EFFECTIVENESS AND SAFETY OF PARS PLANA VITRECTOMY SURGERY USING A NEW HYPERSONIC TECHNOLOGY.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
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Stanga Paulo E, Williams Jon I, Shaarawy Sherif A, Agarwal Amar, Venkataraman Anusha, Kumar Dhivya A, You Timothy T, Hope Richard S
Аннотация
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.
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.