Health Condition 1: null- Diabetic Macular Edema in Diabetic Retinopathy
Conditions
Interventions
Intervention1: Triamcinolone Acetonide
: Injection Triamcinolone Acetonide
4mg / 0.1ml ,single dose, Intravitreally through pars plana route
Control Intervention1: NOT APPLICABLE: NOT APPLICABLE
Sponsors
Govt medical college and Sir Takhatsinhji General Hospital Bhavnagar
Eligibility
Inclusion criteria
Inclusion criteria: 1) Diagnosis of diabetes mellitus ( type or type 2). 2) Age >= 18 years. 3) Able and willing to provide informed consent. 4) Definite retinal thicking due to diabetic macular edema based on clinical examination involving the centre of the macula. 5) Media clarity, papillary dilatation, and patient cooperation sufficient For adequate fundus photographs. 6) IOP
Exclusion criteria
Exclusion criteria: 1) History of chronic renal failure requiring dialysis or kidney transplant. 2) Known allergy to any corticosteroid or any component of the delivery vehicle. 3) History of systemic (e.g. oral, IV, IM, epidural, bursal) corticosteroids within 4 ) months prior to randomization or topical, rectal or inhaled corticosteroids in current use more than 2 times per week. 5) Proliferative diabetic retinopathy. 6) Aphakia. 7) Intraocular pressure >= 25 mmHg. 8) History of open angle glaucoma. 9) History of steroid-induced intraocular pressure elevation that required IOP lowering agents. 10) History of prior treatment with intravitreal corticosteroids within 6 months prior to randomization. 11) History of focal/grid macular photocoagulation within 15 weeks (3.5 months) prior to randomization. 12) History of panretinal scatter photocoagulation (PRP) within prior 4 months or anticipated within the next 6 months following randomization. 13) History of major ocular surgery ( including cataract extraction, scleral buckle, any intraocular surgery etc.) within prior 6 months or anticipated within the next 6 months following randomization. 14) History of prior herpetic ocular infection. 15) An ocular condition is present such that visual acuity would not improve from resolution of macular edema (e.g. foveal atrophy, pigmentary changes, nonretinal conditions).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bestcorrecterd Visual Acuity and Intraocular pressureTimepoint: Day 1, Day 7, Weeks 3, Weeks 6, Weeks 12, Weeks 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| any Adverse eventsTimepoint: Day 1, Day 7, Weeks 3, Weeks 6, Weeks 12, Weeks 24 | — |
Countries
India
Contacts
Public ContactDr Hetal J Patel
Govt. medical college bhavnagar
Outcome results
None listed