July 2019
Volume 60, Issue 9
Free
ARVO Annual Meeting Abstract  |   July 2019
Cross-linking Assisted Infection Reduction: A Randomized Clinical Trial (CLAIR)
Author Affiliations & Notes
  • Jennifer Rose-Nussbaumer
    Ophthalmology, University of California San Francisco, San Francisco, California, United States
    Ophthalmology, The Permanente Medical Group, Redwood City, California, United States
  • Ariana Austin
    Ophthalmology, University of California San Francisco, San Francisco, California, United States
  • Travis C Porco
    Ophthalmology, University of California San Francisco, San Francisco, California, United States
  • Venkatesh Prajna
    Aravind Eye Hospital, India
  • R Naveen
    Aravind Eye Hospital, India
  • Footnotes
    Commercial Relationships   Jennifer Rose-Nussbaumer, None; Ariana Austin, None; Travis Porco, None; Venkatesh Prajna, None; R Naveen, None
  • Footnotes
    Support  K23EY025025
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 2222. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Jennifer Rose-Nussbaumer, Ariana Austin, Travis C Porco, Venkatesh Prajna, R Naveen; Cross-linking Assisted Infection Reduction: A Randomized Clinical Trial (CLAIR). Invest. Ophthalmol. Vis. Sci. 2019;60(9):2222.

      Download citation file:


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

      ×
  • Supplements
Abstract

Purpose : Filamentous fungal keratitis is a challenging disease with poor prognosis. In this randomized clinical trial we compare the efficacy of two commonly used topical antifungal medications, natamycin and amphotericin as well as the effect of adjuvant corneal cross-linking (CXL).

Methods : In this prospective, 2 x 2 factorial design, randomized, outcome-masked clinical trial, study participants presenting with smear positive filamentous fungal ulcers and visual acuity worse than 20/70 were enrolled at Aravind Eye Hospital in Madurai India. Using an adaptive randomization allocation study participants were assigned to 1 of 4 possible treatment arms: 1) natamycin only; 2) natamycin + CXL; 3) amphotericin only; 4) amphotericin + CXL in a 2 x 2 factorial design trial. The primary outcome was culture taken 24 hours after initiating treatment, secondary outcomes included visual acuity, scar size and complication rates including perforation and rate of therapeutic penetrating keratoplasty.

Results : 111 patients were enrolled between January 2016 and March 2018. Table 1 outlines the baseline characteristics which were similar across the 4 treatment groups. There were small differences in culture status (culture positivity rate: natamycin only, 68%; natamycin + CXL, 81%; amphotericin only, 90%; amphotericin + CXL, 78%) and visual acuity (median [IQR], in logMAR: natamycin only, 1.05 [0.62, 1.12]; natamycin + CXL, 1.10 [0.60, 1.70]; amphotericin only, 1.05 [0.62, 1.70]; amphotericin + CXL, 1.22 [0.91, 1.70]). Culture positive ulcers were mostly Fusarium species (52%), Aspergillus (16%), and Curvularias (8%).

Amphotericin had similar efficacy compared with Natamycin with regard to repeat culture positivity, visual acuity, scar size and complication rates (Figure 1). We found no benefit of CXL on 24 hour repeat culture result. Those randomized to CXL had decreased visual acuity at 3 months compared with medical therapy (regression model of 3-month visual acuity by treatment arm, accounting for baseline visual acuity and comparing each arm to natamycin only: natamycin + CXL, coef. 0.42 [p = 0.03]; amphotericin only, coef. 0.10 [p = 0.59]; amphotericin + CXL, coef. 0.25 [p = 0.19]).

Conclusions : Amphotericin has similar efficacy compared to Natamycin for the treatment of filamentous fungal keratitis. There is no benefit to adjuvant CXL for the treatment of moderate fungal keratitis.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

 

 

×
×

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.

×