Prevention of macular edema after cataract surgery

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1008

Inclusion Criteria

All patients undergoing routine phacoemulsification.
Only one eye per patient will be included in the study.
Patients should be able to communicate properly and understand instructions.
All patients must accept possible off-label use of study medication before inclusion in this study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 202
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 806

Exclusion Criteria

General exclusion criteria for participation in this study are:

- age below 21 years old;
- patients already participating in another clinical study;
- post-traumatic cataract
- combined surgery (e.g. combined phacoemulsification and trabeculectomy or phacoemulsification and DSAEK);
- functional monoculus;
- previous ocular surgery;
- progressive glaucoma with severe visual field defects, use of anti-glaucomatous medication or steroid-induced IOP elevation that required IOP-lowering treatment;
- IOP = 25 mmHg;
- history of intra ocular inflammation or uveitis;
- history of pseudoexfoliation syndrome, which is expected to cause peroperative complications (e.g. transillumination defects at the pupillary margin or zonulolysis);
- history of Fuchs' endothelial dystrophy or cornea guttata 3+;
- history of retinal vein occlusion;
- any macular pathology that might influence VA, other than DME (e.g. macular pucker, macular hole, severe age-related macular degeneration (AMD))
- use of intravitreal bevacizumab or ranibizumab in the previous 6 weeks or intravitreal aflibercept in the previous 10 weeks;
- use of intra- or periocular corticosteroids injection in the previous 4 months;
- current use of topical NSAIDs or corticosteroids;
- use of systemic corticosteroids (= 20mg prednisolone or equivalence);
- history of relevant adverse events, including serious adverse events (SAE) occurring after administration of NSAIDs, acetylsalicylic acid, sodium sulphite, corticosteroids or bevacizumab;
- contraindications for use of topical NSAIDs, topical or subconjunctival corticosteroids or intravitreal bevacizumab or related drugs (e.g. tuberculosis, pregnancy, planning to become pregnant in the coming 6 months, nursing mothers);

Exclusion criteria for non-diabetic patients

- Non-diabetic patients with a history of CME will be excluded from participation in the study.

Exclusion criteria for diabetic patients

- Macular edema with a CSMT =450 µm;
- Very severe NPDR or proliferative DR requiring panretinal photocoagulation or vitrectomy;
- Vitreous haemorrhage present during preoperative visit(s);
- Cerebrovascular accident (CVA), myocardial infaction (MI) or other thromboembolic events in the previous 3 months;
- A history of recurrent thromboembolic events;
- A history of severe systemic bleeding in the previous 3 months;
- Major surgery in the previous 3 months;
- History of glaucoma;