Prevention of macular edema after cataract surgery

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1350

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 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1000

Exclusion Criteria

-Age below 21 years old;
-Functional monoculus;
-Previous ocular surgery;
-Diabetes with 1) macular edema with a CSMT of 450 µm or more; 2) very severe nonproliferative or proliferative diabetic retinopathy needing panretinal photocoagulation or vitrectomy; or 3) vitreaous haemorrhage present at initiation visit
- non-diabetic patients with cystoid macular edema
-History of glaucoma, use of anti-glaucomatous medication or steroid-induced IOP elevation that required IOP-lowering treatment;
-IOP = 25 mmHg;
-Post-traumatic cataract;
-History of any ocular inflammation or uveitis;
-History of pseudoexfoliation syndrome, which is expected to cause peroperative complications ;
-History of Fuchs' endothelial dystrophy or cornea guttata 3+;
-History of retinal vein occlusion;
- Any macular pathology that might influence VA, other than diabetic macular edema;
-Cerebrovascular accident, myocardial infarction or other thromboembolic events in the previous 3 months;
-History of recurrent thromboembolic events;
-History of severe systemic bleeding in the previous 3 months;
-Major surgery in the previous 3 months;
-Intravitreal bevacizumab or ranibizumab within in the previous 6 weeks or intravitreal aflibercept within the previous 10 weeks before study initiation;
-Intra- or periocular corticosteroid injection in the previous 4 months;
-Current use of topical NSAIDs or corticosteroids;
-Use of systemic corticosteroids (=20mg prednisolone or equivalence);
-History of relevant (serious) adverse events occurring after administration of NSAID’s, acetylsalicylic acid, sodium sulphite, corticosteroids or bevacizumab;
-Contraindications for use of topical NSAIDs, topical or subconjunctival corticosteroids or intravitreal bevacizumab (e.g. tuberculosis, pregnancy, nursing mothers);
-Combined surgery (e.g. combined phacoemulsification and trabeculectomy or phacoemulsification and descemet stripping automated endothelial keratoplasty )