Chorioretinopathy, Central Serous
Conditions
Brief summary
Preclinical and clinical evidence support the protective effect of crocin on different pathologic pathways involved in central serous chorioretinopathy (CSCR). They involve inflammation, oxidative stress, mineralocorticoid pathway, and also stress-related injuries. It also showed that crocin has a protective effect on the retinal pigmented epithelium (RPE) layer. Based on the mentioned evidence the study designed to evaluate the efficacy and safety of 2-month crocin supplementation (15 mg/d) in 40 patients with CSCR in a randomized controlled blinded clinical trial.
Interventions
DRUGCrocin
15 mg/d
DRUGPlacebo
15 mg/d
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* age of 18-60 years old * The diagnosis of CSCR based on clinical and imagining evaluation * informed consent
Exclusion criteria
* Chronic CSCR * Laser treatment (6 months prior to enrollment) * IVB treatment (3 months prior to enrollment) * Other retinal diseases * History of eye diseases * Diabetes Mellitus * Renal or hepatic diseases * Allergy to saffron or crocin * Pregnancy or lactation * Beta-blocker, diuretic, or corticosteroid (1 week prior to enrollment) Bleeding tendency or any coagulation disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best-corrected visual acuity (BCVA) | 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Foveal thickness (μm) | 8 weeks | measured by OCT imaging |
| Subretinal fluid height (μm) | 8 weeks | measured by OCT imaging |
| Subfoveal choroidal thickness (μm) | 8 weeks | measured by OCT imaging |
| Number of participants need to laser therapy | 8 weeks | based on clinical criteria |
| Total number of reported adverse events | 8 weeks | based on patients reported adverse events |
Countries
Iran
Outcome results
None listed