drugset / Trial / NCT01774474
PRevention of Macular EDema After Cataract Surgery
Phase 3
Completed
1127 enrolled
Maastricht University Medical Center
European Society of Cataract and Refractive Surgeons · collab
RandomizedParallel-groupDouble-blindPrevention
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).
Timeline
- Start
- 2013-07-10
- Primary completion
- 2016-11-04
- Completion
- 2016-11-04
Publications
- Simons RWP, Wielders LHP, Nuijts RMMA, Veldhuizen CA, van den Biggelaar FJHM, Winkens B, Schouten JSAG, Dirksen CD; ESCRS PREMED Study Group. Economic evaluation of prevention of cystoid macular edema after cataract surgery in diabetic patients: ESCRS PREMED study report 6. J Cataract Refract Surg. 2022 May 1;48(5):555-563. doi: 10.1097/j.jcrs.0000000000000785.
- Simons RWP, Wielders LHP, Dirksen CD, Veldhuizen CA, van den Biggelaar FJHM, Winkens B, Schouten JSAG, Nuijts RMMA; ESCRS PREMED Study Group. Economic evaluation of prevention of cystoid macular edema after cataract surgery in patients without diabetes: ESCRS PREMED study report 4. J Cataract Refract Surg. 2021 Mar 1;47(3):331-339. doi: 10.1097/j.jcrs.0000000000000449.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bevacizumab | Monoclonal antibody | 1.25 mg | Intravitreal |
| Comparator | Bromfenac | Other / unclassified | 0.09 % | Topical |
| Comparator | Dexamethasone | Small molecule | 0.1 % | Topical |
| Comparator | Triamcinolone Acetonide | Other / unclassified | 40 mg | Other |