Effect of Crocin on macular and optic nerve head vascular density in non-proliferative diabetic retinopathy

Phase 2

• Conditions: Diabetic Retinopathy.; Type 2 diabetes mellitus with ophthalmic complications; E11.3

• Registration Number: IRCT20210310050669N1
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Adult patients (18 years and older) with type 2 diabetes without central involvement macular edema according to ETDRS criteria (early treatment diabetic retinopathy study) in the studied eye
Best corrective visual acuity equal or upper than 7/10 (20/30) according to Snellen chart
HbA1c has been 6.5-9.5 during the last 3 months
No need for standard treatment including Injection, Macula Laser or Retina Laser
The absence of other serious illnesses, such as liver and kidney failure
The maximum severity of diabetic retinopathy be non- proliferative
Controlled blood pressure or lipid profile in hypertension and hyperlipidemia patients if present

Exclusion Criteria

The presence of other ophthalmic diseases that effects macular edema (like Retinal vein occlusion, uveitis, Epiretinal membrane)
Patients with anterior segmentation of the eye disorders (Cornea, anterior chamber, Iris, and lens)
History of any intraocular surgery except cataract surgery (more than 6 months before entrance study)
Sub foveal hard exudates deposition
Pregnancy, Breast feeding
Need for Standard treatment including Injection, Macula Laser, or Retina Laser
Allergy to saffron
The presence of other ophthalmic diseases that effects vision (glaucoma, vascular obstruction, macular pathology)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Macular and optic nerve head vascular density. Timepoint: Before intervention, and 3 months later. Method of measurement: Optovue Optical Coherence Tomography (OCT).