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. 2016 Nov 1;2016(11):CD006683. doi: 10.1002/14651858.CD006683.pub3

NCT01694212.

Trial name or title Preoperative topic diclofenac as a prevention of postoperative macular edema in patients with diabetic retinopathy
Methods Parallel group RCT
Participants Country: Croatia
120 people aged 60 to 90 years
Inclusion criteria:

  • presence of nonproliferative diabetic retinopathy

  • presence of the cataract (LOCS 2‐3)


Exclusion criteria:

  • other chronic or acute eye diseases

  • hypersensitivity to any component of the diclofenac eye‐drops patients on oral anticoagulant therapy

  • allergy to salycilates
Interventions Intervention: diclofenac
Comparator: placebo
Outcomes Primary Outcome:

  • change of central macular thickness at ‐7, 0, 1, 7, 30, 90 days after the cataract surgery measured with OCT


Secondary Outcome:

  • progression of diabetic retinopathy ‐7 and 90 days after cataract surgery assessed on fundus photography (ETDRS) according to ETDRS criteria

  • IL‐12 concentration immediately before cataract surgery measured in the sample of humour aqueous taken at the beginning of cataract surgery
Starting date October 2012
End date: December 2016
Contact information Ljubo Znaor, MD PhD, Clinical Hospital Center, Split
Notes