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Brief Report
September 2016

Assessment of the Incorporation of Patient-Centric Outcomes in Studies of Minimally Invasive Glaucoma Surgical Devices

Author Affiliations
  • 1Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
  • 2Quintiles Real-World and Late Phase Research, Rockville, Maryland
  • 3Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland
  • 4Division of Ophthalmic and Ear, Nose, and Throat Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland
JAMA Ophthalmol. 2016;134(9):1054-1056. doi:10.1001/jamaophthalmol.2016.2101

Importance  Minimally invasive glaucoma surgical (MIGS) devices are one option for lowering intraocular pressure in patients with glaucoma.

Objective  To examine how often existing clinical studies of MIGS devices registered on ClinicalTrials.gov measure patient-centric outcomes that patients value directly.

Design, Setting, and Participants  We searched ClinicalTrials.gov, a registry of publicly and privately supported clinical studies, on February 20, 2015, for records of MIGS device studies involving patients with glaucoma. Two investigators independently abstracted study design and outcome details from eligible records. We classified outcomes as patient-centric or not patient-centric using a prespecified definition.

Main Outcomes and Measures  Proportion of patient-centric and nonpatient-centric outcomes registered on ClinicalTrials.gov.

Results  We identified 51 eligible studies specifying 127 outcomes. Reduction in intraocular pressure was the most frequent outcome specified (78/127; 61%) and a primary outcome in 41 studies. Patient-centric outcomes—such as adverse events (n = 19; 15%), topical medication use (n = 16; 13%), visual acuity (n = 4; 3%), and health-related quality of life (n = 1; 1%)—were less frequently specified (n = 40; 32%) and a primary outcome in only 12 studies.

Conclusion and Relevance  Patient-centric outcomes that provide insight into the relative desirability and acceptability of the benefits and risks of MIGS devices are not well represented in current clinical studies.