Diabetic Macular Edema
Conditions
Keywords
diabetes, macular edema, triamcinolone, cataract, refractory diabetic macular edema
Brief summary
Triamcinolone has already been used by different routes of administration to treat diabetic macular edema. In the present study, intravitreal injection (IVI) and posterior sub-Tenon's infusion (STI) of triamcinolone acetonide (TA) during phacoemulsification cataract surgery in eyes with refractory diffuse diabetic macular edema are tested.
Interventions
DRUGTriamcinolone acetonide
4 mg
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Refractory diffuse DME unresponsive to focal laser photocoagulation * Best corrected visual acuity between 20/800 and 20/40; Central subfield macular thickness greater than 300 µm
Exclusion criteria
* Previous ocular surgery * Glycosylated hemoglobin (Hb A1C) rate above 10% * History of glaucoma or ocular hypertension * Loss of vision as a result of other causes * Systemic corticoid therapy * Severe systemic disease * Any condition affecting follow-up or documentation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| central subfield macular thickness | baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively |
Secondary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity | baseline and at 2, 4, 8±1, 12±2 and 24±2 weeks postoperatively |
| Intraocular pressure | baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively |
Countries
Brazil
Outcome results
None listed