Effects of Melatonin Supplementation on Sleep Quality in Patients with Advanced Glaucoma: A Randomized, Double-Blind, Placebo-Controlled Crossover Trial
Abstract
PURPOSE
To evaluate the effect of oral melatonin administration in patients with advanced glaucoma on sleep-wake cycle variables recorded by actigraphy on a single night and sleep quality assessed by specific questionnaires.
DESIGN
Prospective, randomized, parallel, crossover and double-blind, therapeutic-type.
PARTICIPANTS
Sixty-four patients aged between 40 and 80 years, diagnosed with advanced primary open-angle glaucoma, were included.
METHODS AND INTERVENTION
Participants received 5 mg of melatonin or placebo daily for 30 days, one-week washout period, all assessments were repeated after each treatment phase. Subjective sleep was evaluated using the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS). Objective sleep parameters total sleep time, wake after sleep onset (WASO), number of awakenings, and sleep efficiency were measured by actigraphy. Vision-related quality of life was assessed using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25). Standardized ophthalmologic exams, visual field testing (SITA Standard 24-2), and OCT-based retinal nerve fiber layer (RNFL) analysis were also performed.
MAIN OUTCOME MEASURES
Primary outcomes were PSQI and actigraphy-measured sleep efficiency. Secondary outcomes included total sleep time, WASO, number of awakenings, ESS, and NEI VFQ-25 scores.
RESULTS
All 64 participants completed the study. No significant differences were found between melatonin and placebo for any sleep or…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 64 participants or records.
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