July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Reducing Adenoviral Patient Infected Days (RAPID) Study: Success in Masking Subjects and Clinicians From Identifying Treatment with Ophthalmic Povidone-Iodine 5% (PVP-I).
Author Affiliations & Notes
  • Meredith Whiteside
    School of Optometry, UC Berkeley , Berkeley, California, United States
  • Ellen Shorter
    University of Illinois, Chicago, Illinois, United States
  • Mary Migneco
    Ophthalmology, Washington University, St. Louis, Missouri, United States
  • Andy Hartwick
    Optometry, Ohio State University, Columbus, Ohio, United States
  • Tammy Than
    Carl Vinson Veterans Medical Center, Dublin, Georgia, United States
  • Jennifer S Harthan
    Illinois College of Optometry, Chicago, Illinois, United States
  • Christina Morettin
    Illinois College of Optometry, Chicago, Illinois, United States
  • Spencer Johnson
    College of Optometry, Northeastern State University, Tahlequah, Oklahoma, United States
  • Mathew Margolis
    Ophthalmology, Washington University, St. Louis, Missouri, United States
  • Julia Huecker
    Ophthalmology, Washington University, St. Louis, Missouri, United States
  • Kelly Olsen
    US. Army Ft. Sam Houston, San Antonio, Texas, United States
  • Crystal Rosemann
    US. Army Ft. Sam Houston, San Antonio, Texas, United States
  • Tave' van Zyl
    Ophthalmology, Harvard Medical School, Boston, Massachusetts, United States
  • Timothy Bossie
    New England College of Optometry, Boston, Massachusetts, United States
  • Mae Gordon
    Ophthalmology, Washington University, St. Louis, Missouri, United States
  • Footnotes
    Commercial Relationships   Meredith Whiteside, None; Ellen Shorter, None; Mary Migneco, None; Andy Hartwick, None; Tammy Than, None; Jennifer Harthan, None; Christina Morettin, None; Spencer Johnson, None; Mathew Margolis, None; Julia Huecker, None; Kelly Olsen, None; Crystal Rosemann, None; Tave' van Zyl, None; Timothy Bossie, None; Mae Gordon, None
  • Footnotes
    Support  NEI Grant 1R34EY023633-01A1
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 3788. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Meredith Whiteside, Ellen Shorter, Mary Migneco, Andy Hartwick, Tammy Than, Jennifer S Harthan, Christina Morettin, Spencer Johnson, Mathew Margolis, Julia Huecker, Kelly Olsen, Crystal Rosemann, Tave' van Zyl, Timothy Bossie, Mae Gordon; Reducing Adenoviral Patient Infected Days (RAPID) Study: Success in Masking Subjects and Clinicians From Identifying Treatment with Ophthalmic Povidone-Iodine 5% (PVP-I).. Invest. Ophthalmol. Vis. Sci. 2018;59(9):3788.

      Download citation file:


      © ARVO (1962-2015); The Authors (2016-present)

      ×
  • Supplements
Abstract

Purpose : The Reducing Adenoviral Patient Infected Days (RAPID) study is a double-masked randomized pilot trial of the safety and efficacy of a one-time, administration of ophthalmic PVP-I 5%. Masking both the participant and the study clinician are important to minimize bias in endpoint assessments in well-conducted clinical trials.

Methods : Eligibility included informed consent, age ≥18, new onset red eye with symptoms ≤4 days and a positive in-office AdenoPlus rapid immunoassay test for adenoviral conjunctivitis. The study eye was randomized to receive a one-time in office treatment of either PVP-I or artificial tears (ATs). After 1 drop of ophthalmic proparacaine 0.5%, 4-5 drops of PVP-I or ATs were placed in the eye. Two minutes after instillation, the eye was lavaged with preservative-free sterile saline. Immediately after treatment and at the day 4 visit, participants were asked to guess whether they received PVP-I, ATs or if they were unsure. On day 14, masked clinicians were asked which treatment they believed the participant received.

Results : At baseline, correct guesses were made by 64% (16/25) of subjects randomized to PVP-I treatment and 29% (7/24) of those randomized to ATs. Overall, 47% (23/49) of participants guessed correctly and 41% (20/49) were unsure. At four days post-treatment, correct guesses were made in 68% (13/19) of subjects receiving PVP-I and 45% (9/20) of participants who received ATs. Overall, 56% (22/39) of participants guessed correctly and 26% (10/39) were unsure on day 4. On day 14, masked clinicians correctly guessed the treatment in 56% (9/16) of the PVP-I group, in 67% (10/15) of the AT group. The clinician correctly guessed the treatment assignment 61% (19/31) and they were unsure 26% (8/31) of the time.

Conclusions : While overall masking of subjects on day 0 and day 4 post treatment was achieved, treatment with PVP-I was more difficult to mask. Clinician masking was less successful than overall subject masking.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

 

Summary of Results

Summary of Results

×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×