title: Assessment of retinal morphology with spectral and time domain OCT in the phase III trials of enzymatic vitreolysis.
abstract: OBJECTIVE
  To determine the relative ability of time domain (TD)-optical coherence tomography (OCT) compared with spectral domain (SD)-OCT to assess vitreoretinal interface abnormalities and pharmacologic treatment of symptomatic vitreomacular adhesion (VMA)/traction (VMT) with or without full-thickness macular hole (FTMH), and the reproducibility of trained readers' evaluation of these images in an interventional phase III program of ocriplasmin.
  
  
  METHODS
  Eyes from the MIVI-TRUST program with concurrent SD-OCT and TD-OCT at baseline and day 28 were included. Pairwise intermodality agreement frequency and interreader reproducibility were calculated for baseline OCT features and the study endpoints of VMA resolution and FTMH closure.
  
  
  RESULTS
  A total 186 eyes (186 patients) met the inclusion criteria for this study. There was excellent agreement between TD-OCT and SD-OCT for the reader-determined presence or absence of VMA (96.7%), FTMH (97.1%), and all other baseline parameters except epiretinal membrane (84.3%), which was detected at a significantly greater rate with SD-OCT than TD-OCT (44.6% vs. 35.3%, P < 0.001). There was excellent agreement for the study endpoints of VMA resolution (95.4%) and FTMH closure (100%) at day 28. Interreader reproducibility was similar but consistently greater with SD-OCT than TD-OCT to detect baseline VMA (kappa 0.6 vs. 0.52); FTMH (kappa 0.9 vs. 0.78); and epiretinal membrane (kappa 0.65 vs. 0.45).
  
  
  CONCLUSIONS
  Readers using SD-OCT or TD-OCT have similar ability to assess vitreoretinal interface abnormalities and outcomes of enzymatic vitreolysis. SD-OCT may be superior for formal clinical trial grading due to greater interreader reproducibility and, therefore, decreased need for arbitration of discrepant values. (ClinicalTrials.gov numbers,NCT00781859, NCT00798317.).
authors.affiliation: Duke Eye Center, Durham, North Carolina 27710, USA.
authors.forename: Francisco A
authors.initials: FA
authors.lastname: Folgar
authors.forename: Cynthia A
authors.initials: CA
authors.lastname: Toth
authors.forename: Francis Char
authors.initials: FC
authors.lastname: DeCroos
authors.forename: Aniz
authors.initials: A
authors.lastname: Girach
authors.forename: Steve
authors.initials: S
authors.lastname: Pakola
authors.forename: Glenn J
authors.initials: GJ
authors.lastname: Jaffe
mesh_terms: D004311:Double-Blind Method; D005341:Fibrinolysin / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006801:Humans; D058449:Intravitreal Injections; D010446:Peptide Fragments / Q000008:administration & dosage*; D011446:Prospective Studies; D015203:Reproducibility of Results; D012160:Retina / Q000473:pathology*; D012167:Retinal Perforations / Q000188:drug therapy* / Q000473:pathology; D041623:Tomography, Optical Coherence / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D010446:Peptide Fragments; C054561:microplasmin; D005341:Fibrinolysin