Diabetic Retinophaty. Diabetic Retinopathy
Conditions
Interventions
Intervention 1: Group 1:Included Patients With 5 mg per Day Of Crocin. Intervention 2: Intervention Group 2: Patients With 15 mg per Day Of Crocin. Intervention 3: DiabeticPpatients With Placebo For
Treatment - Drugs
Group 1:Included Patients With 5 mg per Day Of Crocin.
Intervention Group 2: Patients With 15 mg per Day Of Crocin.
DiabeticPpatients With Placebo For 3 Months Treatments.
Sponsors
Vice Chancellor for Research of Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Adult patients (18 =) with type 1 and 2 diabetes and CSME (clinically significant macular edema) according to ETDRS criteria (early treatment diabetic retinopathy study) in the studied eye, or patients who are diagnosed with cataract as well as central macular thickness in OCT above 296 microns, well controlled diabetes mellitus (HbA1c less than or equal to 8.5 over the last 3 months), and the ability to understand overview of the study, treatment and possible side effects. For cataract patients:Patients who are scheduled to undergo cataract surgery in the next 3 months and are not in a state of emergency. Grading based on a 0 to 4, according to criteria:0 = lens normal, clear, 1 = lens shows a slight blur, 2 = lens represents darkness average, 3 = lens represents the darkness of and the details are, 4 = Lens indicator cataract is done Exclusion criteria: 1. Presence of other eye abnormalities (non-retina causes, etc.) that despite an improvement in macular edema, do not improve visual acuity. 2. Other eye diseases (retinal vein occlusion, uveitis, retinal epithelial membrane) that can affect macular edema. 3. Patients with anterior segment abnormalities of the eye (cornea, anterior chamber, iris, or lens) 4. History of vitrectomy 5. Subfoveal hard exudates deposition 6. Existence treatment required PDR 7. Intraocular surgery within the last 3 months 8. Pregnancy 9. Vitreous hemorrhage
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central Macular Thickness. Timepoint: Before Intervention, and After Three Months. Method of measurement: Spectralis OCT Device.;Measure The Opacity Of The Lens. Timepoint: At The Time Of The Visit And Once After Of The End Of Treatment Period. Method of measurement: Microscopes Equipped With Digital Cameras And Upper Ring Light. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects of crocin. Timepoint: Before intervention,and three months later. Method of measurement: Questionnaire for side effect of crocin. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.Seyed Ahmad Mohajeri
Mashhad University of Medical Sciences
Outcome results
None listed