The efficacy and safety of adjuvant supplementation with green tea extract on diabetic macular edema, a double blind randomized clinical trial
- Conditions
- Diabetic macular edema.Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edemaE11. 311
- Registration Number
- IRCT20110811007297N9
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Patients with type 2 diabetes
Age between 30 and 65 years
Patients diagnosed with Diabetic Macular Edema (DME)
Receive standard treatment with anti-vascular endothelial growth factor (VEGF) therapy with corticosteroids
Central macular thickness (CMT) greater than 350 µm, as measured by spectral domain optical coherence tomography (SD-OCT)
Willing and capable of providing written informed consent
Patients with monocular
Patients with Glaucoma
Epiretinal or vitreomacular membrane tension in fundus examination or OCT
Significant cataract or posterior capsular opacity affecting visual acuity
Vitreous hemorrhage that prevents the posterior view of the fundus
Previous history of vitrectomy surgery
Previous history of cataract surgery in the last three months
High myopia (refractive errors greater than -6 diopters)
Systemic or intravitreal injection of immunosuppressive drugs and corticosteroids
Liver or kidney failure
Pregnant or lactating women
Known sensitivity or intolerance to green tea extract (GTE) or any of the excipients in GTE tablets
Currently taking any medication or herbal supplement that may interfere with the study intervention
Inability or unwillingness to comply with study procedures and follow-up program
Dens vitreous hemorrhage
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method