Is it possible to use long acting steroid preparations such as the dexamethasone intravitreal implant Ozurdex to prevent a deterioration in vision in patients with diabetes undergoing cataract surgery in central Australia.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2015
INTERVENTION: 0.7mg intravitreal dexamethasone implant (Ozurdex) administered during cataract surgery. Followup will be offered monthly, with Ozurdex retreatment up to 4 monthly as clinically indicated. The overall intervention period for this trial will be 12 months. The implant does not need to be removed (it dissolves over time). CONDITION: Cataract Diabetic macular edema Diabetic retinopathy PRIMARY OUTCOME: Best corrected visual acuity measured with a "Rolling E chart". SECONDARY OUTCOME: Adverse events. Known adverse effects specific to this drug include increased intra‐ocular pressure (IOP) and posterior subcapsular cataract formation. IOP will be measured at each visit and treated as required. Development of cataract will not be of concern in this study as the implant will be administered at the time of, and subsequent to cataract surgery. Change in central retinal thickness using Optical Coherence tomography (OCT) Laser treatment required post‐operatively (Yes/no) Number of intravitreal injections required post‐operatively INCLUSION CRITERIA: ‐ Adult patients treated by the Central Australian & Barkly Integrated Eye Health Service, who fit either of the following 2 treatment groups: A. Patients with active DME (defined as macular involving DR, with retinal thickening as assessed on clinical examination), or B. Patients with diabetic retinopathy without active DME ‐ Participants must have significant lens opacity (more than grade 3 for any type of cataract) and scheduled to undergo cataract surgery at the time of enrolment into the study. ‐ Participants must have reduced vision (BCVA impaired to at least the level of (6/9)) in the eye included for the study.
Epistemonikos ID: 88f370a545665e60c3280826d92163080cbb724e
First added on: Aug 25, 2024