Rapid Structural and Functional Improvements in Following 0.19 mg Fluocinolone Acetonide (FAc) Implant in Diabetic Macular Edema Patients With Poor Visual Acuity: 12-month Audit Results From United Arab Emirates
- Conditions
- Diabetic Macular Edema
- Interventions
- Device: 0.19 mg fluocinolone acetonide (FAc) implant
- Registration Number
- NCT03590587
- Lead Sponsor
- Benha University
- Brief Summary
The Health Authority - Abu Dhabi (HAAD) approved the reimbursement of the slow release FAc implant (ILUVIEN) and it is now available for the treatment of diabetic macular edema (DME) in persons who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. We performed a retrospective 12-month audit to assess the efficacy and safety of the FAc implant in our clinical practice.
- Detailed Description
Twenty patients with pseudophakic lenses, treated with ILUVIEN, were investigated to evaluate functional and anatomical characteristics and outcomes (visual acuity \[VA; ETDRS letters score\], central macular thickness \[CMT\] and intraocular pressure \[IOP\]) at baseline, weeks 2-4 and months 3, 6 and 12 months.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- DME
- Pseudophakic
- Other causes of macular edema.
- Phakic
- Know case of gaucoma
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 0.19 mg fluocinolone acetonide (FAc) implant patients treated with 0.19 mg fluocinolone acetonide (FAc) implant for 12 months
- Primary Outcome Measures
Name Time Method BCVA 12 months best corrected visual acuity
- Secondary Outcome Measures
Name Time Method IOP 12 months Intraocular pressure
CMT 12 months Central Macular thickness
Trial Locations
- Locations (1)
Shiekh Khalifa medical city
🇦🇪Abu Dhabi, United Arab Emirates