Diabetic Retinopathy: Effects of Melatonin Treatment on Visual Functions and Circadian Rhythm

Glostrup University Hospital, Copenhagen31 enrolled

Overview

This study evaluates the effect of melatonin 4 mg on circadian rhythm and visual function of patients with diabetes mellitus. Half of the patients will receive melatonin (arm-1) and the other half will receive placebo (arm-2), both groups in 3 weeks. After a week of washout, the patients will cross over to the other treatment arm.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetic Retinopathy Melatonin Circadian Dysrhythmia Circadian Rhythm Sleep Disorder, Unspecified Type

Interventions

Melatonin 4 mg TabletDRUG

Participants are randomized into arm 1 or arm2, recieving melatonin or placebo, respectively, for 21 days, followed by 1 week of washout, and then swichting to the contralateral treatment arm.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diabetic patients * Age range 40-75 years * Participant should be legally competent Exclusion Criteria: * Other known eye disease. * Eye disease manifestation during ocular examination. * Competing neurologic and systemic conditions affecting retina. * Use of any drugs influencing pupillary light reflex and sleep pattern. * Refractive error with need of \> 6 diopter lenses. * Pregnancy * Alcohol consumption during the trial * Lack of cooperation * Allergy to melatonin and/or preservatives in melatonin and placebo * Reduced hepatic function * Fluvoxamin intake due to drug interaction * Consumption of Alpha-1 and beta-1 adnergic antagoists. * Alcohol consumption during treatment

Locations (1)

Department of Ophthalmology, Rigshospitalet-Glostrup

Glostrup Municipality, RegionH, Denmark

Outcomes

Primary Outcomes

Progression of diabetic retinopathy, oscillary potential

Progression of diabetic retinopati measured with electroretinography

Time frame: 3 weeks

Secondary Outcomes

Post-illumination pupillary light response

Melanopsin-mediated pupillary response

Time frame: 3 weeks

Circadian photoentrainment

Salivary melatonin level and sleep assessment

Time frame: 3 weeks

Retinal structure

Retinal structure assessed by optical coherence tomography

Time frame: 3 weeks

Data from ClinicalTrials.gov

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