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P. A. Majmudar, LipiFlow Study Group; A Novel Thermal Pulsation Treatment for Obstructive Meibomian Gland Dysfunction: Applying Heat to the Inner Eyelid Surfaces. Invest. Ophthalmol. Vis. Sci. 2010;51(13):6281.
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To evaluate the clinical utility, safety and effectiveness of the LipiFlow® Thermal Pulsation System compared to standardized iHeatTM Warm Compress System for application of controlled, localized heat therapy in adult patients with chronic meibomian gland dysfunction (MGD), also known as evaporative dry eye.
The study was a non-significant risk, prospective, open-label, randomized, crossover multi-center clinical trial. The 139 enrolled subjects were randomized between LipiFlow® (69 subjects) and warm compress control (70 subjects). At the treatment visit, the LipiFlow® subjects received a single 12-minute LipiFlow® treatment and were reexamined at 1 day, 2 weeks and 4 weeks. Control subjects received a 5-minute iHeatTM treatment and were instructed to perform the same 5-minute treatment daily for 2 weeks. Control subjects were examined at 2 weeks and then received a single 12-minute LipiFlow® crossover treatment with follow-up at 1 day and 2 weeks later. The effectiveness parameters were: meibomian gland (MG) assessment, tear break-up time (TBUT) and dry eye symptoms. The safety parameters were adverse events, slit lamp and retinal evaluation, corneal and conjunctival staining, intraocular pressure, best corrected visual acuity and discomfort during and after treatment.
Only the LipiFlow® treatment resulted in significant improvement in the objective signs of increased MG secretion and TBUT at 2 and 4 weeks. MG secretion at baseline = 6.3±3.5; 2 wks = 14.3±8.7; 4 wks = 16.7±8.7 (p<0.05); no significant change in the control group. TBUT at baseline = 5.5±2.9; 2 wks = 6.9±5.0; 4 wks = 7.4±5.5, (p<0.05); no significant change in the control group. The single LipiFlow® treatment resulted in a greater significant reduction in dry eye symptoms than the 14-day, once-a-day iHeatTM warm compress treatment. There were no unanticipated or serious adverse events with either treatment.
The data support safety and effectiveness of the LipiFlow® Thermal Pulsation System, which applies heat to the inner eyelid surface, in treating MGD. The LipiFlow® System was significantly more effective than the iHeatTM warm compress for improving MG secretion, TBUT and reducing dry eye symptoms.
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