Safety of intracameral levofloxacin in cataract surgery (version 2)

• Research type

  Research Study

• Full title

  Comparison of the Safety of Intracameral Levofloxacin to intracameral Cefuroxime for the prevention of endophthalmitis in cataract surgery (SILC)

• IRAS ID

  23332

• Contact name

  David J Spalton

• Sponsor organisation

  King's College London

• Eudract number

  2009-014054-14

• ISRCTN Number

  ISRCTN31806847

• Research summary

  One of the most serious complications of cataract surgery is endophthalmitis, infection of the eye which can lead to blindness. In 1996, the European Society of Cataract and Refractive Surgery published findings that using the antibiotic cefuroxime inside the eye at the end of surgery reduces the risk of endophthalmitis. Despite these findings, one main reason cited for not following this regime is the lack of a commercially available preparation of cefuroxime of the correct dose. Current practice involves pharmacists or nurses diluting the antibiotic for each individual surgical case. Thus, there is a risk of dilution errors, with unknown consequences. Levofloxacin, a different antibiotic, may be equally effective in preventing post-operative infections. One advantage is its commercial availability in the correct strength. Levofloxacin could be a viable alternative for cataract surgery without the concern of human error. The purpose of this study is to investigate the safety of levofloxacin when it is used in the eye at the end of cataract surgery. We will compare it to cefuroxime in patients requiring cataract surgery in both eyes. 30 patients will be recruited for the study. Each patient will be randomly assigned one of the antibiotics for their first eye and the other antibiotic for their second eye. Surgery will be performed around 5 weeks apart. Post-operative checks in outpatient clinics will be done 1 day, 3 weeks and 12 weeks after surgery for each eye. At each visit different parameters will be tested, namely vision, corneal (clear window at the front of the eye) thickness and cell examination/count, inflammation in the eye, and macular thickness (back of the eye providing central vision) to test the health of the eyes. By having each individual receiving both antibiotics, we can directly compare the safety of the two antibiotics.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  10/H0802/7

• Date of REC Opinion

  23 Mar 2010

• REC opinion

  Further Information Favourable Opinion