Central Serous Chorioretinopathy, Melatonin, Ocular Diseases, Visual Acuity, Macula Abnormality
Conditions
Brief summary
The goal of this clinical trial is to learn if oral melatonin can enhance visual acuity and central macular thickness in central serous chorioretinopathy (CSCR) in adults. The main questions it aims to answer are: 1. How does melatonin affect central macula thickness in CSCR? 2. How does melatonin affect visual acuity in CSCR? Researchers will compare placebo (a look-like substance that contains no drug) to see if melatonin works to treat CSCR. Participants will: 1. Take melatonin or placebo twice a day for one month 2. Visit the clinic after finishing a course of treatment, and 1 and 3 months after that for visual acuity assessment and tests 3. Keep a diary of their symptoms
Interventions
DRUGmelatonin 3mg
In this group, participants will be randomly assigned to take 3 mg tablets of melatonin twice a day for 1 month.
DRUGPlacebo Drug
The placebo is also prepared in the form of tablets with similar packaging as melatonin by the pharmaceutical company. Participants will be randomly assigned to take placebo with the same frequency and duration as melatonin (twice a day for 1 month).
Sponsors
Mohsen Pourazizi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients whose diagnosis of central serous chorioretinopathy is confirmed based on clinical and imaging criteria within the past 6 weeks 2. Patients with minimum age of 18 years old 3. Consent to participate in the study
Exclusion criteria
1. A history of vitrectomy 2. A history of laser surgery in the eye being studied in the past 3 months 3. A history of anti-VEGF injection in the eye being studied in the past 3 months 4. History of patient suspicious for choroidal neovascularization (CNV) 5. Pregnant or nursing patients 6. Patients with significantly compromised visual acuity in the eye being studied due to concomitant ocular condition 7. Patients participating in any other investigational drug study 8. Inability to obtain OCT photographs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| central macular thickness (CMT) | From enrollment to 3 month later | Changes in central macular thickness (CMT) in patients receiving oral melatonin versus patients receiving placebo |
| best visual acuity (BCVA) | From enrollment to 3 months later | Changes in best visual acuity (BCVA) in patients receiving oral melatonin versus patients receiving placebo |
Contacts
Primary ContactMohsen Pourazizi
Outcome results
None listed