Topical citicoline and vitamin B12 versus placebo in the treatment of diabetes-related corneal nerve damage: a randomized double-blind controlled trial.

What Was Tested

This randomized controlled trial looks at Cyanocobalamin (Vitamin B12).

To evaluate the effects of topical citicoline and vitamin B12 (Cit-B12: OMK2, Omikron Italia srl, Italy) on corneal innervation of patients with diabetic neuropathy.

Why It Was Studied

Trial registration NCT03906513, retrospectively registered on 08 April 2019.

Who Took Part

According to the abstract, 30 patients were involved.

At baseline and at months 4, 8, 12, 18 patients underwent the Ocular Surface Disease Index questionnaire (OSDI), tear break-up time, evaluation of corneal and conjunctival staining, Schirmer I test, Cochet-Bonnet esthesiometry, and confocal biomicroscopy of corneal sub-basal plexus (SBP).

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

The patients were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

Blinding on both sides kept the patients and researchers unaware of who received Cyanocobalamin (Vitamin B12).

A placebo (an inactive look-alike) gave the Cyanocobalamin (Vitamin B12) group a baseline to be compared against.

Fiber lenght density (FLD) was calculated using NeuronJ and expressed in mm/mm2.

Raw data and differences from baseline were analysed in the two groups.

What Was Measured

PubMed files the paper under topics including Cornea, Cytidine Diphosphate Choline, Diabetes Mellitus, Diabetic Neuropathies, Dry Eye Syndromes, Tears and Vitamin B 12.

The authors tagged it with the keywords Citicoline, Cornea innervation, Corneal sensitivity, Dry eye disease and Vitamin B12.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Cyanocobalamin (Vitamin B12) in 30 patients.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Its findings take up roughly 5 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2020 (BMC ophthalmology), a journal based in England.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.