title: Health-related quality of life, visual function and treatment satisfaction following intravitreal dexamethasone implant for diabetic macular edema.
abstract: OBJECTIVE
  The aim of this study was to explore and describe quantitatively patient-reported outcome measures (PROMs), ie, health-related quality of life (QoL), visual function and treatment satisfaction, in patients with diabetic macular edema (DME) receiving two different regimens of Ozurdex (intravitreal dexamethasone implant).
  
  
  METHODS
  In this multicenter, prospective study, 100 patients with center-involving refractory DME were randomized 1:1 to either five monthly fixed dosing or optical coherence tomography (OCT)-guided pro re nata (PRN) regimen of dexamethasone intravitreal implant therapy. The primary outcome was the difference between arms in change in PROMs and health-related QoL from baseline to 12 months, as measured by the Retinopathy-Dependent Quality of Life (RetDQoL) questionnaire, Visual Function Questionnaire-25 (VFQ-25) and Retinopathy Treatment Satisfaction Questionnaire (RetTSQ).
  
  
  RESULTS
  There was no statistically significant difference in the RetDQoL score and VFQ-25 score at month 12 compared to those at baseline, whereas the total mean RetTSQ score increased significantly at the exit visit. The two treatment arms did not differ significantly regarding the change in PROMs and health-related QoL questionnaires. Logistic regression analysis showed that visual acuity (VA) of ≥55 letters, central foveal thickness <300 μm and macular volume <9.2 mm3at the exit visit (month 12) predicted a higher change in RetTSQ.
  
  
  CONCLUSIONS
  This study showed that there is a statistically significant improvement in treatment satisfaction, as measured by RetTSQ, in patients with DME treated with dexamethasone intravitreal implant, independent of the dose regimen, namely, fixed or PRN. However, it should be noted that the clinically meaningful change could not be assessed accurately, since no thresholds for clinically meaningful change currently exist for the RetTSQ. On the other hand, there was no significant change in health-related QoL, as measured using VFQ-25 and RetDQoL. Factors affecting the patients' treatment satisfaction were the final VA, the central foveal thickness and the macular volume.
authors.affiliation: NIHR Moorfields Biomedical Research Centre, London.
authors.forename: Jayashree
authors.initials: J
authors.lastname: Ramu
authors.affiliation: NIHR Moorfields Biomedical Research Centre, London.
authors.forename: Irini
authors.initials: I
authors.lastname: Chatziralli
authors.affiliation: The Royal Wolverhampton Hospitals NHS Trust, Wolverhampton.
authors.forename: Yit
authors.initials: Y
authors.lastname: Yang
authors.affiliation: Frimley Health NHS Foundation Trust, Surrey.
authors.forename: Geeta
authors.initials: G
authors.lastname: Menon
authors.affiliation: Bristol Eye Hospital, Bristol.
authors.forename: Clare
authors.initials: C
authors.lastname: Bailey
authors.affiliation: Brighton and Sussex University Hospital, Brighton, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Eckstein
authors.affiliation: NIHR Moorfields Biomedical Research Centre, London.
authors.forename: Phil
authors.initials: P
authors.lastname: Hykin
authors.affiliation: NIHR Moorfields Biomedical Research Centre, London.
authors.forename: Sobha
authors.initials: S
authors.lastname: Sivaprasad
keywords: Ozurdex; PRN; RetDQoL; RetTSQ; VFQ-25; treat-and-extent; treatment