PRevention of Macular EDema After Cataract Surgery

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 peroperative complications;

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

12. history of retinal vein occlusion;

13. any macular pathology that might influence VA, other than DME;

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 (SAE), 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 edema with a CSMT ≥450 µm;

2. very severe NPDR or proliferative DR requiring panretinal photocoagulation or vitrectomy;

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

4. cerebrovascular accident (CVA), myocardial infarction (MI) 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;