Diabetic Macular Edema
Conditions
Brief summary
We have been using DEX for refractory DME for a long time (since 2016). Thus, we are sharing our results , evaluating both anatomical and functional outcomes of DEX therapy for refractory DME.
Detailed description
Our study aims at evaluating both anatomical and functional outcomes of DEX therapy for cases of refractory DME, with both a single injection, and /or with retreatments.
Interventions
DRUGIntravitreal Dexamethasone Implant for refractory Diabetic macular edema:
Intravitreal Dexamethasone implants (DEX) (0.7 mg) (Ozurdex, Allergan, Inc, Irvine, CA, USA) had been used with greater efficacy and safety in DME.
Sponsors
Dar El Oyoun Hospital
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* • Age: 16 or older (Adults) * Sex: both * NTDME with CMT \>300 u * \< 10% reduction in CMT (than previous treatment) * \< 50 u reduction in CMT (than previous treatment) * Worsening of BCVA \> 1 line on E chart. * Duration since Previous treatment is: 3 months with DEX, 1 month with Anti-VEGF * Pseudophakic eyes * NPDR , PRP-treated PDR
Exclusion criteria
* • Phakic eyes * Uncontrolled Glaucoma (IOP \> 24 mmHg, or cup disc ratio 0.8 or more) * Herpetic viral infection. * Untreated PDR
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Central macular thickness (in microns) (CMT change ) | between baseline and 6 months | Change in Central macular thickness (in microns) (CMT change ) |
| Change in Best corrected visual acuity (BCVA change) ) | between baseline and 6 months | lines of Change in Best corrected visual acuity (BCVA change) ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of follow-up ( months) | between baseline and 6 months | Duration of follow-up ( months) |
| CMT change > 100 u | between baseline and 6 months | CMT change \> 100 u (yes / No) |
| Number of DEX injections | between baseline and 6 months | Number of DEX injections |
| BCVA change >= 2 lines | between baseline and 6 months | BCVA change \>= 2 lines (yes / No) |
| Complications : ocular hypertension, pseudo uveitis, endophthalmitis, RD | between baseline and 6 months | Complications : ocular hypertension, pseudo uveitis, endophthalmitis, RD (yes / No) |
| CMT change > 200 u | between baseline and 6 months | CMT change \> 200 u (yes / No) |
| Shift to anti-VEGF during follow-up | between baseline and 6 months | Shift to anti-VEGF during follow-up (Yes or No) |
Countries
Egypt
Outcome results
None listed