IRCT20210310050669N1
Completed
Phase 2
Effect of Crocin on macular and optic nerve head vascular density in non-proliferative diabetic retinopathy patient with non-central macular involvement
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Mashhad University of Medical Sciences
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
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