PRevention of Macular EDema After Cataract Surgery

NCT01774474 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1127

Last updated 2017-04-14

No results posted yet for this study

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

Interventions

DRUG

Bromfenac

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01774474 on ClinicalTrials.gov