Application of Negative Pressure by the Ocular Pressure Adjusting Pump to Provide a Sustained Reduction in IOP.

Autor: Ferguson TJ; Vance Thompson Vision, Sioux Falls, SD, USA., Herndon LW; Duke University, Durham, NC, USA., Terveen DC; Vance Thompson Vision, Sioux Falls, SD, USA., Shah M; New York University Langone Health, New York, NY, USA., Samuelson TW; Minnesota Eye Consultants, Minneapolis, MN, USA., Yoo P; Balance Ophthalmics, Inc., Sioux Falls, SD, USA., Berdahl JP; Vance Thompson Vision, Sioux Falls, SD, USA.
Jazyk: angličtina
Zdroj: Clinical ophthalmology (Auckland, N.Z.) [Clin Ophthalmol] 2024 Nov 06; Vol. 18, pp. 3171-3178. Date of Electronic Publication: 2024 Nov 06 (Print Publication: 2024).
DOI: 10.2147/OPTH.S492530
Abstrakt: Purpose: To evaluate the sustainability of IOP reduction with continuous negative pressure application over an extended duration with use of the Ocular Pressure Adjusting Pump.
Methods: Prospective, controlled, open-label, randomized, single site, pilot study. Subjects with primary open-angle glaucoma (OAG) were enrolled. One eye of each subject was randomized to receive negative pressure application; the fellow eye served as a control. The study eye negative pressure setting was programmed for 60% of the baseline IOP. Subjects wore the Ocular Pressure Adjusting Pump for 8 consecutive hours and IOP measurements occurred at 2-hour intervals for a total of 5 IOP measurements (08:00, 10:00, 12:00, 14:00, 16:00).
Results: Nine subjects successfully enrolled and completed the study. The mean programmed negative pressure setting was -12.0 mmHg. At baseline, the mean IOP in the study eye was 21.4 ± 4.3 mmHg. The mean IOP reduction in the study eye at hours 0, 2, 4, 6, and 8 was 8.1 (37%), 6.4 (28%), 6.3 (29%), 7.3 (34%) and 6.7 (31%), respectively. All IOP measurements during negative pressure application were reduced from baseline. There were no serious adverse events.
Conclusion: The Ocular Pressure Adjusting Pump provides a sustained reduction in IOP while the device is worn with negative pressure applied with an IOP reduction exceeding 25% across 8 hours of continuous wear.
Competing Interests: Drs. Ferguson, Herndon, Terveen, Samuelson and Yoo are consultants for Balance Ophthalmics. Dr. Shah reports consulting fees from AbbVie, Alcon, Glaukos, ONL Therapeutics, Nova, Elios, and Bausch and Lomb, outside the submitted work. Dr. Berdahl is the founder and owner of Balance Ophthalmics. The authors report no other conflicts of interest in this work.
(© 2024 Ferguson et al.)
Databáze: MEDLINE