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Dropless penetrating keratoplasty using a subconjunctival dexamethasone implant: safety pilot study
  1. Marie Caroline Trone1,2,
  2. Sylvain Poinard1,2,
  3. Emmanuel Crouzet1,
  4. Thibaud Garcin1,2,
  5. Marielle Mentek1,
  6. Fabien Forest3,
  7. Marie Matray2,
  8. Gilles Thuret1,2,
  9. Philippe Gain1,2
  1. 1Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Faculty of Medecine, Jean Monnet University, Saint-Etienne, France
  2. 2Ophthalmology Department, University Hospital, Saint-Etienne, France
  3. 3Pathology department, University Hospital, Saint-Etienne, France
  1. Correspondence to Professor Gilles Thuret, Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Medecine Faculty, Jean Monnet University, Saint-Etienne, France; gilles.thuret{at}univ-st-etienne.fr

Abstract

Background/aim Rejection is the main cause of graft failure after penetrating keratoplasty (PK). Its prevention by repeated instillation of steroid eye-drops has not evolved in decades. Poor adherence and discontinuous nature of eye-drop treatment may explain some PK failures. In a rabbit model, we previously demonstrated that a subconjunctival dexamethasone implant was well tolerated and prevented rejection efficiently in the first 5–6 weeks. This clinical trial investigates its tolerance and safety after PK.

Methods Single-centre, phase II non-randomised tolerance and safety pilot study (NCT02834260). Designed to analyse the risk of elevated intraocular pressure (IOP), discomfort and resorption time. Fourteen patients with a low rejection risk indication of PK were enrolled between January 2017 and August 2018. The implant was injected in the 12 o’clock position, 5 mm from the limbus, at the end of PK. A steroid eye-drop treatment was planned when implant resorption was complete. Patients were monitored regularly for 12 months: IOP (main outcome measure at 1 month), discomfort and redness scores, implant status, rejection episode and central corneal thickness by optical coherence tomography. An independent data safety monitoring committee verified safety aspects.

Results No increase in IOP or other adverse event related to the implant was observed. Average resorption time was 6 weeks. The switch to steroid eye-drops was uneventful. One patient, included despite preoperative corneal neovascularisation (unintended protocol deviation) experienced a rejection.

Conclusions This is the first proof of concept that dropless immunosuppression is possible after low rejection risk PK.

Trial registration number NCT02834260.

  • cornea
  • treatment Medical

Data availability statement

Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as online supplemental information. Data are available on reasonable request. Data are available from the corresponding author: gilles.thuret@univ-st-etienne.fr.

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Data availability statement

Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as online supplemental information. Data are available on reasonable request. Data are available from the corresponding author: gilles.thuret@univ-st-etienne.fr.

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Footnotes

  • Contributors MCT, SP and TG: study design, acquisition of data, data management and analysis, critical revision of article. EC, MMe and MMa : study design, data management and analysis, interpretation of data, drafting article. FF, GT and PG : study design, interpretation of data, critical revision of article.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

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

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