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
Overview
- Phase
- Not Applicable
- Sponsor
- Benha University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- BCVA
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pseudophakic
Exclusion Criteria
- •Other causes of macular edema.
- •Know case of gaucoma
Arms & Interventions
1
patients treated with 0.19 mg fluocinolone acetonide (FAc) implant for 12 months
Intervention: 0.19 mg fluocinolone acetonide (FAc) implant (Device)
Outcomes
Primary Outcomes
BCVA
Time Frame: 12 months
best corrected visual acuity
Secondary Outcomes
- CMT(12 months)
- IOP(12 months)
Investigators
Ahmed Elbarky
assistant professor of ophthalmologyu
Benha University