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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210310050669N1

Enrollment

Registered

2021-03-14

Start date

2021-03-17

Completion date

Unknown

Last updated

2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy. Type 2 diabetes mellitus with ophthalmic complications

Interventions

Intervention 1: Intervention group: Receiving one tablet of Crocin (15 mg)daily for 3 months. Intervention 2: Control group: Receiving one tablet of placebo daily for three months.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion 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

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)

Design outcomes

Primary

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

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ali Eslami

Mashhad University of Medical Sciences

eslamia961@mums.ac.ir+98 51 3728 1401

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026