Diabetic Macular Edema
Conditions
Keywords
Aflibercept; cataract; diabetic macular edema
Brief summary
To study whether or not cataract surgery should be deferred until treating the co-existing diabetic macular edema (DME) using intravitreal (IVI) anti-vascular endothelial growth factor (anti-VEGF).
Detailed description
A prospective randomized interventional study included diabetic patients with visually significant cataract and DME. Patients were divided into 2 groups. Group A received three pre-operative intravitreal Aflibercept injections with a monthly interval, the third injection was given intra-operatively. Group B received a single intra-operative injection, and two post-operative injections with a monthly interval. follow up for 6 months.
Interventions
PROCEDUREPhacoemulsification with IVI of aflibercept
IVI was either before or after cataract surgery
Sponsors
Al Hadi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Diabetic patients with visually significant cataract
Exclusion criteria
* previous vitreoretinal surgery * laser or intravitreal injections 6 months prior to the procedure * intractable glaucom * active intra-ocular inflammation * retinal detachment * vitreous hemorrhage * epi-retinal membranes * any other retinal vascular or neuroretinal disease. * Patients with eventual cataract surgeries
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| resolving of macular edema | Sixth month | change in central macular thickness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of visual acuity | Sixth month | measuring of BCVA |
Countries
Kuwait
Outcome results
None listed