Prevention of macular edema after cataract surgery

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

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

Study procedures will be different for diabetic and non-diabetic patients. Therefore, the exclusion criteria will also be different for diabetic and non-diabetic patients.

General Eexclusion 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, 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;

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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