To study the role of suprachoroidal triamcinolone acetate (corticosteroid) injection in patients with diabetic retinopathy and diabetic macular edema

Phase 3

Not yet recruiting

Conditions: Background retinopathy and retinalvascular changes, (2) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere,

Brief Summary: Present study will be conducted to assess the effect of SuprachoroidalTriamcinolone Acetate in cessation of progression of diabetic retinopathy anddiabetic macular edema. Eyes of the patients will be randomized intointervention and control group. Intervention eye will receive suprachoroidal injectionof triamcinolone acetate with the help of indigenously designed suprachoroidalneedle. Control eye will receive sham injection. Injections will be given atthe time of presentation and will be repeated at 1 month and 2 months.

Visual recovery will be assessed by early treatment diabetic retinopathyscale (ETDRS) at presentation, 1 month, 2 months, 3 months and 6 months, andresolution of edema will be assessed by OCT at presentation, 1 month and 6months. Fundus fluorescein angiography will be performed at presentation, 1month, 2 months, 3 months and 6 months to assess retinal blood vessels.

Safety of monthly suprachoroidal Triamcinolone Acetate will be assessedby measuring intra ocular pressure, fundus examination, blood sugar levels bothfasting and post prandial, HbA1c at presentation, 1 month, 2 months, 3 monthsand 6 months.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Patients not willing to participate or ready for followup.
Patients with HTN (160/110mmHg) Patients with any ocular infection, raised Intraocular pressure (IOP), anycorneal pathology, thinned sclera, scleritis, staphyloma, or any other anterior segment pathology except Pseudophakic patients.
Patients diagnosed of any other retinal or vitreous pathologies except diabetic retinopathy and diabetic macular edema.
Diabetic retinopathy old case of Diabetic Macular Edema.
Patients having severe, very severe diabetic retinopathy, proliferative diabetic retinopathy and diabetic macular edema.

Primary Outcome Measures

Name	Time	Method
Improvement in best corrected visual acuity	0, 1 month, 2 month, 3 month 6 month

Secondary Outcome Measures

Name	Time	Method
Reduction in macular edema	pre intervention 1 month, 6 month

Locations (1): GSVM Medical College Kanpur
🇮🇳
Nagar, UTTAR PRADESH, India
GSVM Medical College Kanpur
🇮🇳Nagar, UTTAR PRADESH, India
Dr Deepak Kumar
Principal investigator
9793899874
dkboss9793@gmail.com