Effects of Melatonin Supplementation on Sleep Quality in Patients With Advanced Glaucoma (NCT06868745) | Clinical Trial Compass
CompletedNot Applicable
Effects of Melatonin Supplementation on Sleep Quality in Patients With Advanced Glaucoma
Brazil64 participantsStarted 2022-05-04
Plain-language summary
A prospective, randomized, parallel, crossover, double-blind therapeutic clinical trial was conducted in accordance with the principles of the Resolution nº 466/12 of the National Health Council and was approved by the Ethics and Research Committee of the Federal University of São Paulo, project CEP/UNIFESP n:1023/2020, CAAE: 36946620.9.0000.5505. Written informed consent was obtained from all participants. The study was conducted at the Glaucoma Division and the Department of Psychobiology at the Federal University of São Paulo - UNIFESP/EPM and at the Laser Vision Eye Hospital - Santos/SP between May/2022 and July/2023.
Who can participate
Age range40 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of Primary Open-Angle Glaucoma: Must have a confirmed diagnosis of primary open-angle glaucoma.
* Cup-to-Disc Ratio \> 0.6: The ratio of cup to disc on optic disc imaging must be greater than 0.6.
* Visual Acuity ≥ 0.4 logMAR: Participants must have a visual acuity of 0.4 logMAR or better in the better eye.
* Age: Participants must be aged 40 to 80 years, inclusive.
Exclusion Criteria:
* Pregnancy: Female participants who are pregnant or planning to become pregnant during the study period.
* Current or Past Diagnosis of Depression: Participants with a current or past history of depression.
* Corneal or Retinal Diseases: History or active disease of the cornea or retina (e.g., diabetic retinopathy, macular degeneration).
* Shift Work: Participants who work night shifts or irregular hours.
* Travel Across Time Zones: Participants who have traveled across time zones in the last 30 days prior to enrollment.
* Diagnosed Obstructive Sleep Apnea: History of obstructive sleep apnea or a current diagnosis of the condition.
What they're measuring
1
Effects of Melatonin Replacement on Sleep Quality of Patients with Advanced Glaucoma
Timeframe: From enrollment to the end of treatment in 2 months