UK Multi-centre Medisoft EMR audit of intra-operative pressure event following implant of ILUVIEN^® (fluocinolone acetonide 190 μg).

Abstract

Purpose : ILUVIEN (fluocinolone acetonide [FAc] 190 μg) is available in the UK for treatment of chronic diabetic macular edema (DME) patients insufficiently responsive to other available therapies. As the number of patients treated with ILUVIEN in the UK grows, it is important to measure long-term patient safety and clinical effectiveness in NHS eye units. To assess the safety (occurrence of intra-ocular pressure [IOP] events and their management) and effectiveness (changes in visual acuity (VA; ETDRS letters) and central subfield thickness (CSFT) after initiation of ILUVIEN.

Methods : The Medisoft^TM audit tool was used to search electronic medical records across 14 UK sites in order to identify DME patients treated with ILUVIEN. The 3^rd extract of data took place in September 2016 and the findings are reported herein.

Results : 345 DME eyes from 305 patients were identified. The mean follow-up period was 428 days (up to 919 days). 15.4% of patients experienced an increase in IOP of ≥10 mmHg and 7.2% experienced a rise above 30 mmHg. In 13.9% of patient’s eyes, treatment-emergent IOP was managed with IOP-lowering drops. No eyes required trabeculoplasty. Trabeculectomy was used to manage elevated IOP in two eyes (Table 1). Over the same time frame there were statistically significant improvements in CSFT (-141.3 microns from a baseline of 481 microns), and 94.0% of eyes conserved (>-4 to <+4) or increased their VA at 24 months. By month 6 ≥29.6% (n=42/142) of eyes achieved 20/40 vision of better, versus 15.6% (n=38/243) at baseline, and this percentage improvement was maintained through to month 24 (39.4%; n=13/33) (Figure 1).

Conclusions : The current extraction of EMR data from clinical practice in the UK shows that patients treated with ILUVIEN benefit from mean improvements in VA and patients achieve driving vision, which was sustained up to 24 months, and accompanied by significant reduction in CSFT.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

 

Table 1

 

Figure 1. Percentage of eyes achieving 20/40 or better (note: total numbers of eyes are shown in parenthesis for each time point).