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

Autor: Amar Agarwal, Timothy T. You, Dhivya Ashok Kumar, Sherif A. Shaarawy, Anusha Venkataraman, Richard S. Hope, Jon I Williams, Paulo E. Stanga
Rok vydání: 2020
Předmět:
Adult
Male
Pars plana
ultrasonic
medicine.medical_specialty
genetic structures
medicine.medical_treatment
Visual Acuity
vitrectomy
Tissue Adhesions
Vitrectomy
Vitreomacular traction
Slit Lamp Microscopy
Clinical study
Tonometry
Ocular
03 medical and health sciences
0302 clinical medicine
first-in-human
Humans
Medicine
Ultrasonics
Original Study
Prospective Studies
Fluorescein Angiography
hypersonic
Macular hole
Aged
Aged
80 and over
pars plana vitrectomy
business.industry
General Medicine
First in human
Middle Aged
Retinal Perforations
medicine.disease
hypersonic vitrectomy
eye diseases
Vitreous Hemorrhage
Surgery
Ophthalmoscopy
Ophthalmology
medicine.anatomical_structure
Vitreous hemorrhage
030221 ophthalmology & optometry
Female
sense organs
business
Tomography
Optical Coherence
030217 neurology & neurosurgery
Zdroj: Retina (Philadelphia, Pa.)
ISSN: 0275-004X
Popis: 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.
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.
Databáze: OpenAIRE
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