PRevention of Macular EDema After Cataract Surgery

• Status: Completed
• Trial end date: 2016-11-04
• Target enrollment: 0
• Participant gender: All

Summary

Cystoid macular edema (CME) is a common cause of vision loss after cataract surgery. In the last few years, several new treatments have been tried to address the problem of CME after cataract surgery in diabetic and non-diabetic patients. The investigators will perform a large RCT with the aim to provide more definite evidence-based recommendations for clinical guidelines to prevent the occurrence of CME after cataract surgery in patients with and without diabetes mellitus (DM).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maastricht University Medical Center
• Collaborator: European Society of Cataract and Refractive Surgeons
• Treatments: BB 1101; Bevacizumab; Bromfenac; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ophthalmic Solutions; Tetrahydrozoline; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

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;