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  • Optic disc haemorrhages at baseline as a risk factor for poor outcome in the Idiopathic Intracranial Hypertension Treatment Trial

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Clinical science
Optic disc haemorrhages at baseline as a risk factor for poor outcome in the Idiopathic Intracranial Hypertension Treatment Trial
  1. Michael Wall1,
  2. Matthew J Thurtell2
  3. for the NORDIC Idiopathic Intracranial Hypertension Study Group
  1. 1 Departments of Neurology and Ophthalmology, University of Iowa College of Medicine, Iowa City, Iowa, USA
  2. 2 Department of Ophthalmology, University of Iowa College of Medicine, Iowa City, Iowa, USA
  1. Correspondence to Dr Michael Wall, University of Iowa Hospitals and Clinics, Department of Neurology, 200 Hawkins Dr, PFP, Iowa City, IA 52242–1091, USA; michael-wall{at}uiowa.edu

Abstract

Background The risk of optic disc haemorrhages on visual outcome in idiopathic intracranial hypertension (IIH) is unknown. We report the type and frequency of optic disc haemorrhages and other funduscopic abnormalities at baseline in the study eye of the 133 subjects enrolled in the Idiopathic Intracranial Hypertension Treatment Trial completing 6 months of follow-up.

Methods We reviewed optic disc photographs to tabulate the frequency and type of optic disc haemorrhages, other funduscopic abnormalities and papilloedema grades of the study eye at baseline and analyse if their presence is associated with a poor visual outcome.

Results 27.2% of subjects had nerve fibre layer haemorrhages in at least one eye. Five of seven, 71% of subjects that met criteria for treatment failure, had nerve fibre layer haemorrhages in at least one eye (Fisher's exact test: p=0.02). There was a good correlation between presence of nerve fibre layer haemorrhages and Frisén grade (Spearman's correlation, p=0.002; r=0.271). Subjects with nerve fibre layer haemorrhages had a higher cerebrospinal fluid pressure (40.0 mm water, p=0.04). There was poor correlation between nerve fibre layer haemorrhages at baseline and the perimetric mean deviation change at 6 months. Cotton wool spots were present in 4% of subjects, exudates in 3% and pseudodrusen in 4%.

Conclusions Nerve fibre layer haemorrhages are common in patients with IIH with mild visual loss and correlate with the severity of the papilloedema. They occur more frequently in treatment failure subjects and therefore may be associated with poor visual outcomes.

Trial registration number NCT01003639, Post-results.

  • Clinical Trial
  • Optic Nerve

https://doi.org/10.1136/bjophthalmol-2016-309852

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    Footnotes

    • Collaborators The Neuro-Ophthalmology Research Disease Investigator Consortium (NORDIC) Idiopathic Intracranial Hypertension Study Group. Co-investigator appendix. Co-investigators/sites: New York Eye and Ear Infirmary: Rudrani Banik, MD (Principal Investigator), Sanjay Kedhar, MD (subinvestigator), Flora Levin, MD (investigator), Jonathan Feistmann, MD investigator), Katy Tai, MA (coordinator), Alex Yang, BA (co-coordinator), Karen Tobias, BA (coordinator), Melissa Rivas, BA (co-coordinator), Lorena Dominguez, BA (coordinator), Violete Perez, BA (coordinator); University of Iowa and Department of Veterans Affairs: Reid Longmuir, MD (principal investigator), Matthew Thurtell, MBBS, MSc (subinvestigator), Trina Eden (coordinator), Randy Kardon, MD, PhD (subinvestigator); The Eye Care Group: Robert Lesser, MD (principal investigator), Yanina O'Neil, MD (subinvestigator), Sue Heaton, BS, CCRC (coordinator), Nathalie Gintowt (co-coordinator) Danielle Rudich (co-coordinator); University of Utah: Kathleen Digre, MD (principal investigator), Judith Warner, MD (subinvestigator), Barbara Hart, BS (coordinator), Kimberley Wegner, BS (co-coordinator), Bonnie Carlstrom, COA (coordinator), Susan Allman (coordinator), Bradley Katz, MD, PhD (subinvestigator), Anne Haroldsen (regulatory); Bascom Palmer Eye Institute, University of Miami: Byron L. Lam MD (principal investigator), Joshua Pasol MD (subinvestigator), Potyra R Rosa MD (coordinator), Alexis Morante MS (co-coordinator), Jennifer Verriotto MS (coordinator); Bethesda Neurology: David Katz, MD (principal investigator), Tracy Asbury (coordinator), Robert Gerwin, MD (subinvestigator), Mary Barnett (data entry); Swedish Medical Center: Steven Hamilton, MD (principal investigator), Caryl Tongco (coordinator), Beena Gangadharan (co-coordinator), Eugene May, MD (sub-investigator); Dean A McGee Eye Institute: Anil Patel, MD (principal investigator), Bradley Farris, MD (subinvestigator), R Michael Siatkowsk, MD (subinvestigator), Heather Miller, LPN (coordinator), Vanessa Bergman (co-coordinator), Kammerin White (coordinator), Steven O'Dell (lumbar puncture), Joseph Andrezik (lumbar puncture), Timothy Tytle (lumbar puncture); University of Pennsylvania: Kenneth Shindler MD, PhD (principal investigator), Joan Dupont (coordinator), Rebecca Salvo (coordinator), Sheri Drossner (co-coordinator), Susan Ward (coordinator), Jonathan Lo (coordinator), Stephanie Engelhard (coordinator), Elizabeth Windsor (coordinator), Sami Khella (lumbar puncture), Madhura Tamhankar, MD (subinvestigator); Washington University in St Louis School of Medicine: Gregory Van Stavern, MD (principal investigator), Jamie Kambarian (coordinator), Renee Van Stavern, MD (subinvestigator), Karen Civitelli (regulatory), J Banks Shepherd, MD (subinvestigator); Emory University: Beau B Bruce, MD (principal investigator), MS; Valérie Biousse (subinvestigator), MD; Nancy J Newman, MD (investigator); Judy Brower, MMSc, COMT (coordinator); Linda Curtis, BSM (co-coordinator); University of Alabama Birmingham: Michael Vaphiades, DO (principal investigator), Karen Searcey (coordinator), Lanning Kline, MD (subinvestigator), Roy McDonald (coordinator); Raleigh Neurology Associates, PA: Syndee J Givre, MD, PhD (principal investigator), Tippi Hales (coordinator), Penni Bye (coordinator), Keisha Fuller (coordinator), Kenneth M Carnes, MD, (subinvestigator), Kimberly James (regulatory), Marisol Ragland (data entry); Saint Louis University: Sophia M Chung, MD (principal investigator), Dawn M Govreau, COT (coordinator), John T Lind, MD, MS (subinvestigator); David and Ilene Flaum Eye Institute, University of Rochester School of Medicine and Dentistry: Zoe Williams, MD (principal investigator), George O'Gara (coordinator), Kari Steinmetz (coordinator), Mare Perevich (coordinator), Karen Skrine (coordinator), Elisabeth Carter (coordinator), Rajeev Ramchandran, MD (subinvestigator); Ohio State University: Steven Katz, MD (principal investigator), Marc Criden, MD (investigator), Gina Coman, RMA, CPC, OCS (co-coordinator), John McGregor, FACS, MD (subinvestigator), Andrea Inman (regulatory); Johns Hopkins University: Prem S Subramanian, MD, PhD (principal investigator), Paul N Hoffman, MD, PhD (investigator), Marianne Medura (coordinator), M Michaele Hartnett (coordinator), Madiha Siddiqui (coordinator), Diane Brown (coordinator), Ellen Arnold (coordinator), Jeff Boring, MD (subinvestigator), Neil R Miller, MD (subinvestigator); University of Southern California: Peter Quiros, MD (principal investigator), Sylvia Ramos (coordinator), Margaret Padilla (coordinator), Lupe Cisneros (coordinator), Anne Kao, MD (subinvestigator), Carlos Filipe Chicani, MD (subinvestigator), Kevin Na (regulatory); University of Houston: Rosa Tang, MD, MPH, MBA (principal investigator), Laura Frishman, PhD (coordinator), Priscilla Cajavilca, MD (coordinator), Sheree Newland, LVN (coordinator), Liat Gantz, OD, PhD (coordinator), Maria Guillermo Prieto, MD (coordinator), Anastas Pass, OD, JD (coordinator), Nicky R Holdeman, OD, MD (subinvestigator); University of Minnesota: Michael S Lee, MD (principal investigator), Helen Roemhild (coordinator), Wendy Elasky (coordinator), Anne Holleschau (coordinator), Jody Fissgus (coordinator), Jamie Walski (coordinator), Andrew Harrison, MD (subinvestigator); Oregon Health and Science University: Julie Falardeau MD (principal investigator), William Hills MD (subinvestigator), Cristi Bryant (coordinator), Donna Kim MD (investigator), Rebecca Armour MD (investigator), Lori Higginbotham (coordinator); University of Virginia: Steven A Newman, MD (principal investigator), Kristina Holbrook (coordinator), Laura D Cook, MD (subinvestigator), Holly Bacon (data entry), Janis Beall, COT (technician), Thomas Goddard, COA (technician), William Hall (technician), Debbie Hamilton (photographer), Alan Lyon (photographer); University of Calgary: William Fletcher, MD, FRCPC (principal investigator), Suresh Subramaniam, MSc, MD, FRCPC (investigator), Jeannie Reimer (coordinator), Jeri Nickerson (coordinator), Fiona Costello, MD, FRCPC (subinvestigator); The Greater Baltimore Medical Center: Vivian Rismondo-Stankovich, MD (principal investigator), Maureen Flanagan, CO, COA (coordinator), Allison Jensen, MD (subinvestigator); Stony Brook University: Patrick Sibony, MD (principal investigator), Ann Marie Lavorna, RN (coordinator), Mary Mladek, COT (coordinator), Ruth Tenzler, RN (coordinator), Robert Honkanen, MD (subinvestigator), Jill Miller-Horn, MD, MS (lumbar puncture), Lauren Krupp, MD (lumbar puncture); Massachusetts Eye and Ear Infirmary: Joseph Rizzo, MD (principal investigator), Dean Cestari, MD (subinvestigator), Neal Snebold, MD (investigator), Brian Vatcher (coordinator), Christine Matera (coordinator), Edward Miretsky, BA (coordinator), Judith Oakley, BA (coordinator), Josyane Dumser (coordinator), Tim Alperen, BA (coordinator), Sandra Baptista-Pires (coordinator), Ursula Bator, OD (coordinator), Barbara Barrett, RN (coordinator), Charlene Callahan (coordinator), Sarah Brett (coordinator), Kamella Zimmerman (coordinator), Marcia Grillo (coordinator), Karen Capaccioli (coordinator); Duke Eye Center and Duke University Medical Center: M Tariq Bhatti MD (principal investigator), LaToya Greene COA,CRC (coordinator), Maria Cecilia Santiago-Turla (coordinator), Noreen McClain (coordinator), Mays El-Dairi MD (subinvestigator); University of Texas Health Science Center at San Antonio: Martha Schatz, MD (principal investigator), John E Carter, MD (subinvestigator), Patrick O'Connor, MD (subinvestigator), Daniel Mojica (coordinator), Joan Smith (coordinator), Yolanda Trigo (coordinator), Sherry Slayman Kellogg (coordinator), Alexandra Martinez (coordinator), Paul Comeau (photographer), Andres Sanchez (photographer), Nathan McCarthy (photographer), Erika Perez (COT), Carlos Bazan (lumbar puncture); Florida State University College of Medicine: Charles Maitland, MD (principal investigator), H Logan Brooks, Jr, MD (investigator), Ronda Gorsica (coordinator), Brian Sherman, MD (subinvestigator), Joel Kramer, MD (subinvestigator); Rutgers-New Jersey Medical School: Larry Frohman, MD (principal investigator) Amanda Ribeiro (coordinator), Kathryn Boschert (coordinator), Yu fei Tu (coordinator), Susan Rivera (coordinator), Roger Turbin, MD (subinvestigator); Queen's University-Hotel Dieu Hospital: Martin ten Hove, MD, MEng (principal investigator), Adriana Breen, RN, BScN (coordinator), Craig Simms (coordinator), Mary Kemp (regulatory), Jim Farmer, MD (subinvestigator); William Beaumont Hospital: Robert Granadier, MD (principal investigator), Tammy Osentoski, RN (coordinator), Kristi Cumming, RN (coordinator), Bobbie Lewis, RN (coordinator), Lori Stec, MD (subinvestigator); University of Illinois: Jorge C Kattah, MD (principal investigator), John Pula, MD (subinvestigator), Mary Rose Buttice, LPN, CCRC (coordinator), Kimberly DuPage RN, BSN, CCRC (coordinator), Kimberly Cooley RN, BSN, CCRC (coordinator), Judith Beck RN (coordinator), CCRP, Lynn Bannon (Technician), Cynthia Guede RN, BSN (coordinator); SUNY Upstate Medical University: Luis Mejico, MD (principal investigator), Melissa Ko, MD (subinvestigator), Burk Jubelt, MD (investigator), Megan Grosso, PAC (coordinator), Mark Chilton (coordinator), Mary Lou Watson (data entry), Jennifer Moore (coordinator); Wake Forest University: Tim Martin, MD (principal investigator), Cara Everhart, COA (coordinator), Joan Fish, RN (coordinator), Lori Cooke, RN (coordinator), J Paul Dickinson, MD (subinvestigator); LSU Health Sciences Center: Marie D Acierno, MD (principal investigator), Rachelle Watts, RN (coordinator), Amy Thomassie, RN (coordinator), Aravinda Rao, MD (subinvestigator), Trisha Mary Chiasson (regulatory); Mount Sinai Medical Center: Janet C Rucker, MD (principal investigator), Christine Hannigan (coordinator), Ilana Katz-Sand, MD (subinvestigator), Deepali Rajguru, MD (subinvestigator); University of Kentucky College of Medicine: Sachin Kedar, MD (principal investigator), Nubia Vega, CCRP (coordinator), Stephanie Morris, CCRP (coordinator), Andrew Pearson, MD (subinvestigator), Mike Hanson (photographer); Dietary Weight Loss Program: Betty Kovacs, Richard Weil, Med, CDE, Xavier Pi-Sunyer (New York Obesity Nutrition Research Center). Fundus Reading Center: Steven Feldon, MD, MBA, William Fisher, Dorothea Castillo, Valerie Davis, Lourdes Fagan, Rachel Hollar, Tammy Keenan, Peter MacDowell (David and Ilene Flaum Eye Institute at the University of Rochester Medical Center). Visual Field Reading Center: John Keltner, MD, Kim Plumb, Laura Leming, John S Werner, PhD (UC Davis Department of Ophthalmology and Vision Science); Danielle Harvey, PhD (UC Davis Department of Public Health Sciences, Division of Biostatistics); Chris Johnson, PhD (University of Iowa). Optical Coherence Tomography Reading Center: John Keltner, MD, John S Werner, Kim Plumb, Laura Leming (UC Davis Department of Ophthalmology and Vision Science). Data Coordination and Biostatistics Center: Jan Bausch, BS, Shan Gao, MS, Xin Tu, PhD, Hua He, PhD, Arthur Watts, BS (Biostatistics); Debbie Baker, Radu Constantinescu, MD, Karen Helles, Nichole McMullen, Bev Olsen, Larry Preston, Victoria Snively, Ann Stoutenburg (CHET/CTCC) (David and Ilene Flaum Eye Institute, University of Rochester School of Medicine and Dentistry); Deborah Friedman, MD (UT Southwestern Medical Center). NORDIC headquarters: O Iyore Ayanru, Elizabeth-Ann Moss, Pravin Patel (Roosevelt Hospital). Consultant: Richard Mills, MD (Glaucoma Consultants Northwest). Data Safety Monitoring Board Members: Maureen Maguire, PhD (Chair) (University of Pennsylvania), William Hart, Jr, MD, PhD, Joanne Katz, ScD, MS (Johns Hopkins), David Kaufman, DO (Michigan State University), Cynthia McCarthy, DHCE MA, John Selhorst, MD (Saint Louis University School of Medicine). Adjudication Committee: Kathleen Digre, MD (University of Utah); James Corbett, MD, FAAN (University of Mississippi Medical Center); Neil R Miller, MD (Johns Hopkins University); Richard Mills, MD (Glaucoma Consultants Northwest).

    • Contributors MW was the Study Director for the IIHTT conducted the study, analysed the data and wrote the manuscript. MJT analysed the data and assisted in writing the manuscript.

    • Funding This work was supported by the National Eye Institute grant number NORDIC 1U10EY017281–01A1.

    • Competing interests None declared.

    • Ethics approval University of Iowa Institutional Review Board.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Data sharing is planned for the near future.

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