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Blood derived treatment from two allogeneic sources for severe dry eye associated to keratopathy: a multicentre randomised cross over clinical trial
  1. Emilio Campos1,
  2. Piera Versura1,
  3. Marina Buzzi2,
  4. Luigi Fontana3,
  5. Giuseppe Giannaccare1,
  6. Marco Pellegrini1,
  7. Nico Lanconelli4,
  8. Alessandra Brancaleoni5,
  9. Fabiana Moscardelli1,
  10. Stefano Sebastiani1,
  11. Cristiana Vaselli2,
  12. Vanda Randi2
  1. 1Ophthalmology Unit, DIMES, Alma Mater Studiorum University of Bologna and S.Orsola-Malpighi Teaching Hospital, Bologna, Italy
  2. 2Emilia Romagna Cord Blood Bank-Transfusion Service, AOU of Bologna Sant'Orsola-Malpighi Teaching Hospital, Bologna, Italy
  3. 3Ophthalmology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy
  4. 4Department of Physics and Astronomy, University of Bologna, Bologna, Italy
  5. 5Ospedale degli Infermi di Rimini, Rimini, Italy
  1. Correspondence to Dr Piera Versura, DIMES-Ophthalmology Unit, Univ Bologna, Bologna, Italy, Italy; piera.versura{at}unibo.it

Abstract

Aim To compare the efficacy of cord blood and peripheral adult donor blood serum eyedrops, controlled for growth factor content, in the treatment of severe dry eye diseases (DED) resistant to conventional therapy.

Methods This was a multicentre randomised, double-masked, cross-over clinical trial. Sixty patients diagnosed as severe DED, associated to persistent corneal epithelial defects were randomised and equally assigned to group A (treated with cord blood serum (CBS)) or group B (treated with PBS), eyedrops administered eight times/day for 1 month. Primary outcome was the pretreatment and post-treatment change in corneal fluorescein staining. Secondary outcomes included the pretreatment and post-treatment change in Ocular Surface Disease Index (OSDI) questionnaire and Visual Analogue Score (VAS) of subjective symptoms, Schirmer I test, tear break-up time and conjunctival staining. Patients with relapse in signs or symptoms after further 2 months switched to the remaining group for one additional month. Data were statistically analysed (p<0.05).

Results Corneal staining was more significantly reduced after the CBS treatment, both VAS and OSDI score reduction was observed in both groups, but group A reported significantly less grittiness and pain. Nineteen patients shifted in the crossover period, the within individual comparison confirmed a better recovery in the CBS treatment period. Reduction in epithelial damage was positively associated with epidermal growth factor, transforming growth factorα and platelet-derived growth factor content. Levels of interleukins (IL-13) were positively associated with symptom decrease.

Conclusions Overall, DED signs improved after both CBS and PBS treatments, with potential advantages of CBS for subjective symptoms and corneal damage reduction.

Clinical trial registration NCT03064984.

  • clinical trial
  • cornea
  • ocular surface
  • wound healing
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Footnotes

  • Contributors EC, PV, LF: design of the work. MB, CV, LF, GG, MP, AB, SS, FM: data collection. PV, LF, MP, GG, NL, SS: data analysis and interpretation. PV, MB, MP, NL, VR: drafting the article. EC, PV, LF, GG: critical revision of the article. All authors: final approval of the version to be published.

  • Funding This work was supported by Emilia Romagna Regional Blood Center (grant protocol n. 60400 – 2015 to Marina Buzzi).

  • Competing interests None declared.

  • Patient consent for publication Obtained.

  • Ethics approval This study protocol was approved by the Comitato Etico Indipendente Azienda Ospedaliero Universitaria di Bologna, Policlinico S. Orsola-Malpighi (local Ethical Committee), and by the Ethical Committees of the two other clinical sites involved (Reggio Emilia and Rimini).

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

  • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.

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