Intraoperative Dexamethasone Implant Improves Outcome of Cataract Surgery With Diabetic Macular Edema
Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
Summary
This study is undertaken to determine the effect of intravitreal long acting dexamethasone
implant, (Ozurdex®) in improving outcome of cataract surgery in patients with diabetic
macular edema.
Diabetic Macular Edema and cataract constitute important causes of visual impairment in
patients with diabetes. Cataract surgery in patients with diabetic retinopathy is associated
with progression of retinopathy.
Several modalities such as non-steroidal anti-inflammatory agents, carbonic anhydrase
inhibitors, corticosteroids, hyperbaric oxygen, laser photocoagulation and vitrectomy with
internal limiting membrane peeling have been tried for managing inflammatory cystoid macular
edema.
Intravitreal Triamcinolone Acetonide (TA), a water insoluble steroid, has been shown to
reduce the retinal thickness and improve the visual acuity. However, recurrence of macular
edema in patients who receive intravitreal TA is a major concern as the patients need
multiple repeat injections.
In search for the ideal corticosteroid preparation, a Dexamethasone Posterior Segment Drug
Delivery System (Dexamethasone DDS - Ozurdex®, Allergan Inc, Irvine, California) was recently
developed. Promising results have been shown in certain patients with persistent diabetic
macular edema receiving this intravitreal drug delivery system with improvement in visual
acuity
The present study introduces a novel concept of using intraoperative Ozurdex ® implant in
patients with diabetes mellitus while undergoing cataract surgery to minimize the worsening
of diabetic maculopathy.
Phase:
Phase 4
Details
Lead Sponsor:
Postgraduate Institute of Medical Education and Research