PRevention of Macular EDema After Cataract Surgery
NCT01774474 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1127
Last updated 2017-04-14
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).
Conditions
- Cystoid Macular Edema
- Cataract
- Diabetes Mellitus
Interventions
- DRUG
-
Bromfenac
- DRUG
- DRUG
- DRUG
-
Triamcinolone Acetonide
Sponsors & Collaborators
-
European Society of Cataract and Refractive Surgeons
collaborator OTHER -
Maastricht University Medical Center
lead OTHER
Principal Investigators
-
prof. Rudy MM Nuijts, MD, PhD · University Eye Clinic Maastricht, University Hospital Maastricht
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-07-10
- Primary Completion
- 2016-11-04
- Completion
- 2016-11-04
Countries
- Austria
- Belgium
- Germany
- Hungary
- Netherlands
- Portugal
- Spain
Study Locations
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