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Assessment of retinal morphology with spectral and time domain OCT in the phase III trials of enzymatic vitreolysis.

Publication ,  Journal Article
Folgar, FA; Toth, CA; DeCroos, FC; Girach, A; Pakola, S; Jaffe, GJ
Published in: Invest Ophthalmol Vis Sci
October 25, 2012

PURPOSE: 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.).

Duke Scholars

Published In

Invest Ophthalmol Vis Sci

DOI

EISSN

1552-5783

Publication Date

October 25, 2012

Volume

53

Issue

11

Start / End Page

7395 / 7401

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Tomography, Optical Coherence
  • Retinal Perforations
  • Retina
  • Reproducibility of Results
  • Prospective Studies
  • Peptide Fragments
  • Ophthalmology & Optometry
  • Intravitreal Injections
  • Humans
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Folgar, F. A., Toth, C. A., DeCroos, F. C., Girach, A., Pakola, S., & Jaffe, G. J. (2012). Assessment of retinal morphology with spectral and time domain OCT in the phase III trials of enzymatic vitreolysis. Invest Ophthalmol Vis Sci, 53(11), 7395–7401. https://doi.org/10.1167/iovs.12-10379
Folgar, Francisco A., Cynthia A. Toth, Francis Char DeCroos, Aniz Girach, Steve Pakola, and Glenn J. Jaffe. “Assessment of retinal morphology with spectral and time domain OCT in the phase III trials of enzymatic vitreolysis.Invest Ophthalmol Vis Sci 53, no. 11 (October 25, 2012): 7395–7401. https://doi.org/10.1167/iovs.12-10379.
Folgar FA, Toth CA, DeCroos FC, Girach A, Pakola S, Jaffe GJ. Assessment of retinal morphology with spectral and time domain OCT in the phase III trials of enzymatic vitreolysis. Invest Ophthalmol Vis Sci. 2012 Oct 25;53(11):7395–401.
Folgar, Francisco A., et al. “Assessment of retinal morphology with spectral and time domain OCT in the phase III trials of enzymatic vitreolysis.Invest Ophthalmol Vis Sci, vol. 53, no. 11, Oct. 2012, pp. 7395–401. Pubmed, doi:10.1167/iovs.12-10379.
Folgar FA, Toth CA, DeCroos FC, Girach A, Pakola S, Jaffe GJ. Assessment of retinal morphology with spectral and time domain OCT in the phase III trials of enzymatic vitreolysis. Invest Ophthalmol Vis Sci. 2012 Oct 25;53(11):7395–7401.

Published In

Invest Ophthalmol Vis Sci

DOI

EISSN

1552-5783

Publication Date

October 25, 2012

Volume

53

Issue

11

Start / End Page

7395 / 7401

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Tomography, Optical Coherence
  • Retinal Perforations
  • Retina
  • Reproducibility of Results
  • Prospective Studies
  • Peptide Fragments
  • Ophthalmology & Optometry
  • Intravitreal Injections
  • Humans