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.

Phase 2

Recruiting

• Conditions: Diabetic retinopathy; Diabetic macular edema; Metabolic and Endocrine - Diabetes; Cataract; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12615000118505
• Lead Sponsor: Alice Springs Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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.

Exclusion Criteria

- Prior intervention in the affected eye, including intravitreal anti-VEGF injections within the last 6 weeks, laser within the last 3 months, or Intravitreal triamcinolone within the last 6 months of time of surgery.
- History of open-angle glaucoma or steroid induced IOP elevation that required IOP-lowering treatment, or, IOP greater than or equal to 25.
- Eyes with concurrent ocular pathology other than DME causing visual loss.
- Patients under the age of 18.

Study & Design

• Study Type: Interventional
• Study Design: Not specified