Evaluating Efficacy and Safety of Oral Melatonin in Acute Central Serous Chorioretinopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: melatonin 3mg, Placebo Drug.
- Who it may be relevant to
- Registry conditions: Central Serous Chorioretinopathy, Melatonin, Ocular Diseases, Visual Acuity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating Efficacy and Safety of Oral Melatonin in Acute Central Serous Chorioretinopathy (CSCR): a Double-blind Randomized Clinical Trial
Overview
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
- 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).
Primary outcome measures
- central macular thickness (CMT) [Time frame: From enrollment to 3 month later]
- best visual acuity (BCVA) [Time frame: From enrollment to 3 months later]
Eligibility criteria
Inclusion criteria
- Patients whose diagnosis of central serous chorioretinopathy is confirmed based on clinical and imaging criteria within the past 6 weeks
- Patients with minimum age of 18 years old
- Consent to participate in the study
Exclusion criteria
- A history of vitrectomy
- A history of laser surgery in the eye being studied in the past 3 months
- A history of anti-VEGF injection in the eye being studied in the past 3 months
- History of patient suspicious for choroidal neovascularization (CNV)
- Pregnant or nursing patients
- Patients with significantly compromised visual acuity in the eye being studied due to concomitant ocular condition
- Patients participating in any other investigational drug study
- Inability to obtain OCT photographs
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06809751 · IR.ARI.MUI.REC.1403.234