PRevention of Macular EDema After Cataract Surgery

Sponsor
Maastricht University Medical Center
Study ID
NCT01774474
Phase
PHASE3
Status
Completed

Conditions

  • Cataract
  • Cystoid Macular Edema
  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bromfenac — DRUG
  • Dexamethasone — DRUG
  • Bevacizumab — DRUG
  • Triamcinolone Acetonide — DRUG

Study Details

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).

Key Dates

First listed
Jan 24, 2013
Start date
Jul 10, 2013
Status verified
May 2016
Primary completion
Nov 4, 2016
Completion
Nov 4, 2016

Study Design

Enrollment
1,127 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Non diabetics: bromfenac
    bromfenac 0.09% eye drops twice daily starting two days before surgery and continuing 2 weeks postoperatively
  • Active Comparator: Non diabetics: dexamethasone
    dexamethasone 0.1% eye drops four times daily starting two days before surgery and continuing four times daily during the first postoperative week and one drop less per day every following week
  • Active Comparator: Non diabetics: bromfenac & dexamethasone
    bromfenac 0.09% eye drops twice daily starting two days before surgery and continuing 2 weeks postoperative \& dexamethasone 0.1% eye drops four times daily starting two days before surgery and continuing four times daily during the first postoperative week and one drop less per day every following week
  • Active Comparator: Diabetics: eye drops
    bromfenac 0.09% eye drops twice daily starting two days before surgery and continuing 2 weeks postoperative \& dexamethasone 0.1% eye drops four times daily starting two days before surgery and continuing four times daily during the first postoperative week and one drop less per day every following week
  • Active Comparator: Diabetics: eye drops & TA
    bromfenac 0.09% eye drops twice daily starting two days before surgery and continuing 2 weeks postoperative \& dexamethasone 0.1% eye drops four times daily starting two days before surgery and continuing four times daily during the first postoperative week and one drop less per day every following week \& a peroperative subconjunctival injection of 40 mg triamcinolone acetonide (TA, Triesence/Vistrec)
  • Active Comparator: Diabetics: eye drops & bevacizumab
    bromfenac 0.09% eye drops twice daily starting two days before surgery and continuing 2 weeks postoperative \& dexamethasone 0.1% eye drops four times daily starting two days before surgery and continuing four times daily during the first postoperative week and one drop less per day every following week \& a peroperative intravitreal injection of 1.25 mg bevacizumab (Avastin)
  • Active Comparator: Diabetics: eye drops, TA & bevacizumab
    bromfenac 0.09% eye drops twice daily starting two days before surgery and continuing 2 weeks postoperative, dexamethasone 0.1% eye drops four times daily starting two days before surgery and continuing four times daily during the first postoperative week and one drop less per day every following week \& a peroperative subconjunctival injection of 40 mg triamcinolone acetonide (TA) \& a peroperative intravitreal injection of 1.25 mg bevacizumab

Primary Outcome Measure

Change in central subfield mean macular thickness as a measurement of efficacy [ Time Frame: 6 weeks postoperatively ]

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