Evaluating Efficacy and Safety of Oral Melatonin in Acute Central Serous Chorioretinopathy
NCT06809751 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2025-02-05
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
Conditions
- Central Serous Chorioretinopathy
- Melatonin
- Ocular Diseases
- Visual Acuity
- Macula Abnormality
Interventions
- DRUG
-
melatonin 3mg
In this group, participants will be randomly assigned to take 3 mg tablets of melatonin twice a day for 1 month.
- DRUG
-
Placebo 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 & Collaborators
-
Mohsen Pourazizi
lead OTHER
Principal Investigators
-
Mohsen Pourazizi · Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-01
- Primary Completion
- 2025-05-01
- Completion
- 2025-06-01
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