Randomized Clinical Trial: Effects of Melatonin Supplementation on Sleep Quality in Patients with Advanced Glaucoma

The study included 64 patients with a diagnosis of advanced primary open-angle glaucoma in both eyes.

Patients were classified as glaucoma cases if they had at least 3 repeatable, consecutive, abnormal visual field test results, defined as a pattern standard deviation (PSD) outside the 95% normal confidence limits or a Glaucoma Hemifield Test (GHT) result outside normal limits matching the appearance of the optic disc, presenting a Mean deviation of <-12.00 dB in the better eye(7,14,17), according to the Hoddap-Parish-Anderson classification for glaucoma severity, using the SITA-Standard strategy, with no involvement of the fixation region (absence of statistically significant points in the central 5º for both total and pattern deviation).

Patients were considered as glaucomatous if they had signs of glaucomatous optic neuropathy based on optic disc stereophotographs. Evidence of glaucomatous damage to the optic disc nerve was considered if they had RNFL defects or localized or diffuse neuroretinal rim loss. There were 32 participants in the melatonin group and 32 in the placebo group. The age range of the volunteers was over 40 years and under 80 years.

Subjects were excluded if they were younger than 40 or older than 80 years; best-corrected visual acuity of less than 0.4 logMAR; Patients who work at night or recently traveled across time zones, use topical or systemic medications that could disrupt circadian rhythms, for example Benzodiazepines, Non-benzodiazepines (hypnotics), Sedative antidepressants, Melatonin and melatonin agonists, patients with previously defined obstructive sleep apnea or other disorders such as depression and insomnia were excluded. Only patients with an open angle on gonioscopy were included in our study.

Each participant received melatonin 5 mg and placebo for a period of 30 days at different time points. The packages were identical, each labeled with the letters F and I. Only the supervisor Dr. Augusto Paranhos Junior, had knowledge of which package contained the original drug. Additionally, the pills within the packages were identical and supplied by the same researcher, who was not informed about the significance of the letters on the packaging.