title: Assessment of the Incorporation of Patient-Centric Outcomes in Studies of Minimally Invasive Glaucoma Surgical Devices.
abstract: Minimally invasive glaucoma surgical (MIGS) devices are one option for lowering intraocular pressure in patients with glaucoma.
  
  
  
  To examine how often existing clinical studies of MIGS devices registered on ClinicalTrials.gov measure patient-centric outcomes that patients value directly.
  
  
  
  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.
  
  
  
  Proportion of patient-centric and nonpatient-centric outcomes registered on ClinicalTrials.gov.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
authors.forename: Jimmy T
authors.initials: JT
authors.lastname: Le
authors.affiliation: Quintiles Real-World and Late Phase Research, Rockville, Maryland.
authors.forename: Shilpa
authors.initials: S
authors.lastname: Viswanathan
authors.affiliation: Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Michelle E
authors.initials: ME
authors.lastname: Tarver
authors.affiliation: Division 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.
authors.forename: Malvina
authors.initials: M
authors.lastname: Eydelman
authors.affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
authors.forename: Tianjing
authors.initials: T
authors.lastname: Li
mesh_terms: D002986:Clinical Trials as Topic; D004867:Equipment Design; D005901:Glaucoma / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D007429:Intraocular Pressure; D019060:Minimally Invasive Surgical Procedures / Q000295:instrumentation*; D018802:Patient-Centered Care / Q000379:methods*; D011788:Quality of Life; D014065:Tonometry, Ocular; D014130:Trabeculectomy / Q000295:instrumentation*; D014792:Visual Acuity