Primary open angle glaucoma
Conditions
Interventions
Each of the 64 participants received 5 mg of melatonin and placebo for 30 days at different time points. The packages containing the medications were identical, labeled with the letters F and I. The r
Sponsors
Universidade Federal de Sao Paulo ( UNIFESP)
Associação Fundo de Incentivo à Pesquisa ( AFIP)
Eligibility
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients over 40 years of age and under 80 years of age; both genders; diagnosed with glaucoma (determined by at least 2 criteria: optic nerve excavation on retinography examination, greater than 0.6; typical defect in perimetry; localized damage to the nerve fiber layer); informed consent form granted
Exclusion criteria
Exclusion criteria: Patients with a history of depression; intraocular surgeries (except cataract surgery); ocular trauma; who work at night; systemic medications for sleep disorders; or intolerance to the use of medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the quality of sleep in patients with advanced glaucoma after 30 days of melatonin 5 mg and 30 days of placebo, comparing the two medications;To evaluate the effects on sleep quality after the use of melatonin 5 mg and placebo, through sleep questionnaires, quality of life and actigraphy | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess sleep quality after 30 days of melatonin 5 mg and 30 days of placebo, using the actigraph;To evaluate the effects on sleep quality after using melatonin 5 mg and placebo with the Epworth Sleepiness Scale sleep questionnaire ;To assess quality of life after the use of melatonin 5 mg and placebo, with the 25-Item National Eye Institute Visual Function Questionnaire;To assess sleep quality after the use of 5 mg of melatonin and placebo, using the Pittsburgh Sleep Quality Index questionnaire | — |
Countries
Brazil
Contacts
Public ContactPriscilla Nogueira
Universidade Federal de Sao Paulo ( UNIFESP)
Outcome results
None listed