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Alvin Relucio, Jonathan He, Paul Ellingson; Level one evidence for minimally invasive glaucoma surgery: clinical trial design lessons from COMPASS. Invest. Ophthalmol. Vis. Sci. 2018;59(9):2043.
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© ARVO (1962-2015); The Authors (2016-present)
Informed use of Minimally Invasive Glaucoma Surgery (MIGS) devices requires data from well-designed randomized controlled trials that comply with accepted standards. The COMPASS trial demonstrated the safety and effectiveness of the CyPass Micro-Stent in lowering unmedicated intraocular pressure (IOP) in subjects with primary open-angle glaucoma undergoing cataract surgery. This trial was the first clinical evaluation of a MIGS device to adhere to FDA Guidance on Premarket Studies of Implantable MIGS Devices and ANSI Standards for Ophthalmics – Implantable Glaucoma Devices.
In accordance with FDA and ANSI guidelines, full medication washout was performed prior to diurnal IOP evaluations, and safety and effectiveness were evaluated through 2-year follow-up. Subjects were randomized to receive CyPass + cataract surgery or cataract surgery alone. A sample size of 505 subjects (372 CyPass, 133 control) was needed for the hypothesis test of the primary effectiveness endpoint (≥20% reduction in IOP) and to detect at least one safety event in the CyPass + cataract surgery group with a probability of ≥0.95, if the safety event rate was ≥1%; this sample size assumes an annual dropout rate of 10%.
Actual dropout rate was less than half the planned rate; a total of 482 subjects (95.4%) completed the 24-month visit (355 CyPass, 127 control). The number of major protocol deviations was extremely low (n = 40) and subject accountability was excellent (100% at 24 months). The precisely defined study population, medication washout, and protocol-defined reintroduction of medications per ANSI guidelines, allowed robust conclusions to be drawn on the safety and effectiveness of CyPass in lowering IOP.
The COMPASS trial was the first study to adhere to FDA and ANSI guidelines, and its size and scope make it a landmark in the field of clinical glaucoma research. The rigorous study design and excellent study conduct provide valuable evidence to support informed decisions for glaucoma surgical interventions.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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