Baseline OCT measurements in the idiopathic intracranial hypertension treatment trial, part I: quality control, comparisons, and variability

OCT Sub-Study Committee for NORDIC Idiopathic Intracranial Hypertension Study Group, Peggy Auinger, Mary Durbin, Steven Feldon, Mona Garvin, Randy Kardon, John Keltner, Mark Kupersmith, Patrick Sibony, Kim Plumb, Jui-Kai Wang, John S Werner, Michael Wall, James Corbett, Steven Feldon, Deborah Friedman, John Keltner, Karl Kieburtz, Mark Kupersmith, Michael P McDermott, Eleanor B Schron, David Katz, Tippi Hales, Cindy Casaceli, Rudrani Banik, Sanjay Kedhar, Flora Levin, Jonathan Feistmann, Katy Tai, Alex Yang, Karen Tobias, Melissa Rivas, Lorena Dominguez, Violete Perez, Reid Longmuir, Matthew Thurtell, Trina Eden, Randy Kardon, Robert Lesser, Yanina O'Neil, Sue Heaton, Nathalie Gintowt, Byron L Lam, Joshua Pasol, Potyra R Rosa, Alexis Morante, Jennifer Verriotto, David Katz, Tracy Asbury, Robert Gerwin, Mary Barnett, Steven Hamilton, Caryl Tongco, Beena Gangadharan, Eugene May, Anil Patel, Bradley Farris, R Michael Siatkowsk, Heather Miller, Vanessa Bergman, Kammerin White, Steven O'Dell, Joseph Andrezik, Timothy Tytle, Kenneth Shindler, Joan Dupont, Rebecca Salvo, Sheri Drossner, Susan Ward, Jonathan Lo, Stephanie Engelhard, Elizabeth Windsor, Sami Khella, Madhura Tamhankar, Gregory Van Stavern, Jamie Kambarian, Renee Van Stavern, Karen Civitelli, J Banks Shepherd, Michael Vaphiades, Jason Swanner, A Blane Jett, Karen Searcey, Frankie Webb, Ashley Knight, Shereka Lewis, Lanning Kline, Ronald Braswell, Syndee J Givre, Tippi Hales, Penni Bye, Keisha Fuller, Kenneth M Carnes, Kimberly James, Marisol Ragland, Sophia M Chung, Dawn M Govreau, John T Lind, Zoe Williams, George O'Gara, Kari Steinmetz, Mare Perevich, Karen Skrine, Elisabeth Carter, Rajeev Ramchandran, Steven Katz, Marc Criden, Gina Coman, John McGregor, Andrea Inman, Prem S Subramanian, Paul N Hoffman, Marianne Medura, M Michaele Hartnett, Madiha Siddiqui, Diane Brown, Ellen Arnold, Jeff Boring, Neil R Miller, Peter Quiros, Sylvia Ramos, Margaret Padilla, Lupe Cisneros, Anne Kao, Carlos Filipe Chicani, Kevin Na, Rosa Tang, Laura Frishman, Priscilla Cajavilca, Sheree Newland, Liat Gantz, Maria Guillermo Prieto, Anastas Pass, Nicky R Holdeman, William Fletcher, Suresh Subramaniam, Jeannie Reimer, Jeri Nickerson, Fiona Costello, Vivian Rismondo-Stankovich, Maureen Flanagan, Allison Jensen, Patrick Sibony, Ann Marie Lavorna, Mary Mladek, Ruth Tenzler, Robert Honkanen, Jill Miller-Horn, Lauren Krupp, Joseph Rizzo, Dean Cestari, Neal Snebold, Brian Vatcher, Christine Matera, Edward Miretsky, Judith Oakley, Josyane Dumser, Tim Alperen, Sandra Baptista-Pires, Ursula Bator, Barbara Barrett, Charlene Callahan, Sarah Brett, Kamella Zimmerman, Marcia Grillo, Karen Capaccioli, M Tariq Bhatti, LaToya Greene, Maria Cecilia Santiago-Turla, Noreen McClain, Mays El-Dairi, Charles Maitland, H Logan Brooks Jr, Ronda Gorsica, Brian Sherman, Joel Kramer, Robert Granadier, Tammy Osentoski, Kristi Cumming, Bobbie Lewis, Lori Stec, Betty Kovacs, Richard Weil, Xavier Pi-Sunyer, William Fisher, Dorothea Castillo, Valerie Davis, Lourdes Fagan, Rachel Hollar, Tammy Keenan, Peter MacDowell, John Keltner, Kim Plumb, Laura Leming, Chris Johnson, John Keltner, John S Werner, Kim Plumb, Laura Leming, Danielle Harvey, Jan Bausch, Shan Gao, Xin Tu, Debbie Baker, Deborah Friedman, Karen Helles, Nichole McMullen, Bev Olsen, Larry Preston, Victoria Snively, Ann Stoutenburg, O Iyore Ayanru, Elizabeth-Ann Moss, Pravin Patel, Richard Mills, Maureen Maguire, William Hart Jr, Joanne Katz, David Kaufman, Cynthia McCarthy, John Selhorst, Kathleen Digre, James Corbett, Neil R Miller, Richard Mills, OCT Sub-Study Committee for NORDIC Idiopathic Intracranial Hypertension Study Group, Peggy Auinger, Mary Durbin, Steven Feldon, Mona Garvin, Randy Kardon, John Keltner, Mark Kupersmith, Patrick Sibony, Kim Plumb, Jui-Kai Wang, John S Werner, Michael Wall, James Corbett, Steven Feldon, Deborah Friedman, John Keltner, Karl Kieburtz, Mark Kupersmith, Michael P McDermott, Eleanor B Schron, David Katz, Tippi Hales, Cindy Casaceli, Rudrani Banik, Sanjay Kedhar, Flora Levin, Jonathan Feistmann, Katy Tai, Alex Yang, Karen Tobias, Melissa Rivas, Lorena Dominguez, Violete Perez, Reid Longmuir, Matthew Thurtell, Trina Eden, Randy Kardon, Robert Lesser, Yanina O'Neil, Sue Heaton, Nathalie Gintowt, Byron L Lam, Joshua Pasol, Potyra R Rosa, Alexis Morante, Jennifer Verriotto, David Katz, Tracy Asbury, Robert Gerwin, Mary Barnett, Steven Hamilton, Caryl Tongco, Beena Gangadharan, Eugene May, Anil Patel, Bradley Farris, R Michael Siatkowsk, Heather Miller, Vanessa Bergman, Kammerin White, Steven O'Dell, Joseph Andrezik, Timothy Tytle, Kenneth Shindler, Joan Dupont, Rebecca Salvo, Sheri Drossner, Susan Ward, Jonathan Lo, Stephanie Engelhard, Elizabeth Windsor, Sami Khella, Madhura Tamhankar, Gregory Van Stavern, Jamie Kambarian, Renee Van Stavern, Karen Civitelli, J Banks Shepherd, Michael Vaphiades, Jason Swanner, A Blane Jett, Karen Searcey, Frankie Webb, Ashley Knight, Shereka Lewis, Lanning Kline, Ronald Braswell, Syndee J Givre, Tippi Hales, Penni Bye, Keisha Fuller, Kenneth M Carnes, Kimberly James, Marisol Ragland, Sophia M Chung, Dawn M Govreau, John T Lind, Zoe Williams, George O'Gara, Kari Steinmetz, Mare Perevich, Karen Skrine, Elisabeth Carter, Rajeev Ramchandran, Steven Katz, Marc Criden, Gina Coman, John McGregor, Andrea Inman, Prem S Subramanian, Paul N Hoffman, Marianne Medura, M Michaele Hartnett, Madiha Siddiqui, Diane Brown, Ellen Arnold, Jeff Boring, Neil R Miller, Peter Quiros, Sylvia Ramos, Margaret Padilla, Lupe Cisneros, Anne Kao, Carlos Filipe Chicani, Kevin Na, Rosa Tang, Laura Frishman, Priscilla Cajavilca, Sheree Newland, Liat Gantz, Maria Guillermo Prieto, Anastas Pass, Nicky R Holdeman, William Fletcher, Suresh Subramaniam, Jeannie Reimer, Jeri Nickerson, Fiona Costello, Vivian Rismondo-Stankovich, Maureen Flanagan, Allison Jensen, Patrick Sibony, Ann Marie Lavorna, Mary Mladek, Ruth Tenzler, Robert Honkanen, Jill Miller-Horn, Lauren Krupp, Joseph Rizzo, Dean Cestari, Neal Snebold, Brian Vatcher, Christine Matera, Edward Miretsky, Judith Oakley, Josyane Dumser, Tim Alperen, Sandra Baptista-Pires, Ursula Bator, Barbara Barrett, Charlene Callahan, Sarah Brett, Kamella Zimmerman, Marcia Grillo, Karen Capaccioli, M Tariq Bhatti, LaToya Greene, Maria Cecilia Santiago-Turla, Noreen McClain, Mays El-Dairi, Charles Maitland, H Logan Brooks Jr, Ronda Gorsica, Brian Sherman, Joel Kramer, Robert Granadier, Tammy Osentoski, Kristi Cumming, Bobbie Lewis, Lori Stec, Betty Kovacs, Richard Weil, Xavier Pi-Sunyer, William Fisher, Dorothea Castillo, Valerie Davis, Lourdes Fagan, Rachel Hollar, Tammy Keenan, Peter MacDowell, John Keltner, Kim Plumb, Laura Leming, Chris Johnson, John Keltner, John S Werner, Kim Plumb, Laura Leming, Danielle Harvey, Jan Bausch, Shan Gao, Xin Tu, Debbie Baker, Deborah Friedman, Karen Helles, Nichole McMullen, Bev Olsen, Larry Preston, Victoria Snively, Ann Stoutenburg, O Iyore Ayanru, Elizabeth-Ann Moss, Pravin Patel, Richard Mills, Maureen Maguire, William Hart Jr, Joanne Katz, David Kaufman, Cynthia McCarthy, John Selhorst, Kathleen Digre, James Corbett, Neil R Miller, Richard Mills

Abstract

Purpose: Optical coherence tomography (OCT) has been used to investigate papilledema in single-site, mostly retrospective studies. We investigated whether spectral-domain OCT (SD-OCT), which provides thickness and volume measurements of the optic nerve head and retina, could reliably demonstrate structural changes due to papilledema in a prospective multisite clinical trial setting.

Methods: At entry, 126 subjects in the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT) with mild visual field loss had optic disc and macular scans, using the Cirrus SD-OCT. Images were analyzed by using the proprietary commercial and custom 3D-segmentation algorithms to calculate retinal nerve fiber layer (RNFL), total retinal thickness (TRT), optic nerve head volume (ONHV), and retinal ganglion cell layer (GCL) thickness. We evaluated variability, with interocular comparison and correlation between results for both methods.

Results: The average RNFL thickness > 95% of normal controls in 90% of eyes and the RNFL, TRT, ONH height, and ONHV showed strong (r > 0.8) correlations for interocular comparisons. Variability for repeated testing of OCT parameters was low for both methods and intraclass correlations > 0.9 except for the proprietary GCL thickness. The proprietary algorithm-derived RNFL, TRT, and GCL thickness measurements had failure rates of 10%, 16%, and 20% for all eyes respectively, which were uncommon with 3D-segmentation-derived measurements. Only 7% of eyes had GCL thinning that was less than fifth percentile of normal age-matched control eyes by both methods.

Conclusions: Spectral-domain OCT provides reliable continuous variables and quantified assessment of structural alterations due to papilledema. (ClinicalTrials.gov number, NCT01003639.).

Keywords: OCT; intracranial hypertension; optical coherence tomography; papilledema.

Copyright 2014 The Association for Research in Vision and Ophthalmology, Inc.

Figures

Figure 1
Figure 1
High-definition five-line raster through the ONH showing the difficulty in including the entire vertical dimensions of the swollen optic disc. For each raster line, the ONH elevation was measured by manually placing a vertical line from a line connecting the RPE layer temporal and nasal neural canal borders to the top of the ONH.
Figure 2
Figure 2
Three-dimensional segmentation of the ONH region volume scan. Top: Actual axial images. Bottom: Images flattened to allow 3D segmentation. Red line defines internal limiting membrane. Yellow lines follow Bruch's membrane and RPE. Pink line defines the RNFL layer border.
Figure 3
Figure 3
Three dimensional segmentation compared to ZM calculations for average RNFL thickness.
Figure 4
Figure 4
Three-dimensional segmentation compared to ZM calculations for average TRT.
Figure 5
Figure 5
Three-dimensional segmentation compared to ZM calculations for average GCL+IPL thickness.

Source: PubMed

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