PREvention of Macular EDema after cataract surgery

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 889

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.

Exclusion Criteria

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 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 during the course of the study, 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 corticosteroids injection in the previous 4 months;
16. current use of topical NSAIDs or corticosteroids;
17. use of systemic corticosteroids (at least 20mg 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.;Diabetic patients will be excluded in case of:
1. macular edema with a CSMT *450 µm;
2. very severe non-proliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR) 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the change in central subfield mean macular thickness<br /><br>in the 1 mm area (central subfield macular thickness, CSMT) as compared to<br /><br>baseline at 6 weeks postoperatively. </p><br>

Secondary Outcome Measures