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

NCT01774474.

Trial name or title PRevention of Macular EDema After Cataract Surgery (PREMED)
Methods Parallel group RCT
Participants Country: Netherlands
1135 people aged 21 years and older
Inclusion criteria:

  • all patients undergoing routine phacoemulsification (one eye per patient)

  • willing and/or able to comply with the scheduled visits and other study procedures

  • able to communicate properly and understand instructions

  • accepting possible off‐label use of intravitreal bevacizumab and/or subconjunctival preservative‐free TA


Exclusion criteria will be different for non‐diabetic and diabetic patients. All ophthalmic exclusion criteria are applicable to the study eye only, unless stated otherwise.
General exclusion criteria for participation in this study are:

  1. age below 21 years old;

  2. participation in another clinical study;

  3. post‐traumatic cataract;

  4. combined surgery;

  5. functional monoculus;

  6. previous ocular surgery;

  7. progressive glaucoma with severe visual field defects, use of anti‐glaucomatous medication or steroid‐induced IOP elevation that required IOP‐lowering treatment;

  8. IOP ≥ 25 mmHg;

  9. history of any intraocular inflammation or uveitis;

  10. history of pseudoexfoliation syndrome, which is expected to cause preoperative complications;

  11. history of Fuchs' endothelial dystrophy or cornea guttata 3+;

  12. history of retinal vein occlusion;

  13. any macular pathology that might influence visual acuity, other than diabetic macular oedema;

  14. use of intravitreal bevacizumab or ranibizumab in the previous 6 weeks or intravitreal aflibercept in the previous 10 weeks;

  15. use of intra‐ or periocular corticosteroid injection in the previous 4 months;

  16. current use of topical NSAIDs or corticosteroids;

  17. use of systemic corticosteroids (≥ 20 mg prednisolone or equivalence);

  18. history of relevant adverse events, including serious adverse events, occurring after administration of NSAIDs, acetylsalicylic acid, sodium sulphite, corticosteroids or bevacizumab;

  19. contraindications for use of topical NSAIDs, topical or subconjunctival corticosteroids or intravitreal bevacizumab or related drugs.


Non‐diabetic patients with a history of CME will be excluded from participation in the study. Additionally, diabetic patients will be excluded from participation in case of:

  1. macular oedema with a CSMT ≥ 450 µm;

  2. very severe non‐proliferative diabetic retinopathy or proliferative diabetic retinopathy requiring panretinal photocoagulation or vitrectomy;

  3. vitreous haemorrhage present during preoperative visit(s);

  4. cerebrovascular accident, myocardial infarction or other thromboembolic events in the previous 3 months;

  5. a history of recurrent thromboembolic events;

  6. a history of severe systemic bleeding in the previous 3 months;

  7. major surgery in the previous 3 months;

  8. history of glaucoma.
Interventions Intervention: bromfenac
Intervention: bromfenac and dexamethasone
Comparator: dexamethasone
Outcomes Primary outcome:

  • change in central subfield mean macular thickness at 6 weeks postoperatively


Secondary outcomes:

  • Clinically significant macular oedema at 12 weeks postoperatively


Other outcome measures at 6 and 12 weeks see clinicaltrials.gov/ct2/show/NCT01774474
Starting date July 2013
End date: October 2016
Contact information Prof. Rudy MM Nuijts, MD, PhD rudy.nuijts@0mumc.nl
Laura HP Wielders, MD laura.wielders@mumc.nl
Notes