Macular Edema Following Cataract Surgery Clinical Trial
Official title:
Trientine Hydrochloride for the Prevention of Macular Edema After Cataract Surgery in Patients With Type 2 Diabetes Mellitus
The primary purpose of the protocol is to evaluate whether Trientine Hydrochloride, a copper chelator which is an agent that binds with and removes copper, will be effective in minimizing macular edema after cataract surgery in individuals with type 2 diabetes. It is our hypothesis that there will be a reduction in copper-attributed inflammation after surgery resulting a decrease in edema.
Individuals with type II Diabetes Mellitus who present to the UBC/VGH Eye Care Centre for
cataract surgery will be offered participation in this study. Cataract surgery will be
performed according to the surgeons' normal protocols and the present standards of care;
however, subjects will be randomized to either a 10-day course of oral Trientine at
1500mg/day administered for 7 days prior to and 3 days after the surgery, or to placebo.
Urinary copper levels will be evaluated before and after Trientine administration to
determine the efficacy of copper chelation at the time of surgery.
Baseline ocular exams, bloodwork and urine collection will be organized or performed at the
two screening visits up to two months before the date of cataract surgery according to the
research protocol (flowsheet included at the end). Subjects will also be evaluated at Day1
post-operative, Day 7 (Week #1) post operative, and Day 28-30 (Month 1)post operative with
Ocular Coherence Tomography (retinal thickness measurements). Fundus photography and visual
acuity testing will be done at Screening and month 1. A final phlebotomy to rule out copper
deficiency anemia will be required at month 1 as well.
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