Evaluation of vitamin D effect on diabetic macular edema

Not Applicable

Recruiting

• Conditions: diabetic macular edema.; Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema; E08.311

• Registration Number: IRCT20200407046978N1
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 May 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients with diabetes mellitus type 2 and diabetic macular edema
Central macular thickness equal and greater than 300 micron
Corrected distance visual acuity of greater than 0.1 LogMAR

Exclusion Criteria

History of any intraocular surgery (except uncomplicated cataract surgery which at least 6 months are passed)
History of intravitreal injection of bevacizumab, other anti-VEGFs and steroid within 3 past months
Epiretinal membrane or vitreomacular traction
History of retinal vascular accidents
History of uveitis
Pregnant or breastfeeding women
Using vitamin supplementation
Not taking vitamin D supplementation based on the study protocol during follow up period
Patients with severe vitamin D deficiency (<10 ng/ml)
Macular disease and consequent visual impairment due to causes other than diabetic macular edema
Hypercalcemia and hyperphosphatemia
Serum creatinin > 3 mg/dl

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in central macular thickness in microns. Timepoint: Before treatment, 1 month, 3 months and 6 months after third baseline IVB. Method of measurement: Optical coherence tomography device.