Trial reportBMC ophthalmology2020
Topical citicoline and vitamin B12 versus placebo in the treatment of diabetes-related corneal nerve damage: a randomized double-blind controlled trial.
Trial report in BMC ophthalmology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03906513 (Evaluation of the Efficacy of OMK2 in Recovering Corneal Neural Damage in Patients With Diabetes), which is not on this map. Cited by 13 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evaluation of the Efficacy of OMK2 in Recovering Corneal Neural Damage in Patients With Diabetes
Who cites it
13 citing papers in PubMed, 24 citations in OpenAlex.
- The Utility of Oral Vitamin B1 and Mecobalamin to Improve Corneal Nerves in Dry Eye Disease: An In Vivo Confocal Microscopy Study.Nutrients · 2022Trial
- Review
- Diabetic dry eye: advances in pathogenesis, diagnostic strategies, and therapeutic approaches.Frontiers in medicine · 2026Review
- Aging and Corneal Nerve Health: Mechanisms of Degeneration and Emerging Therapies for the Cornea.Cells · 2025Review
- Methods for the evaluation of corneal nerve fibres in diabetes mellitus by in vivo confocal microscopy: a scoping review.BMJ open · 2025Article
- Relationship between ocular surface pain and corneal nerve loss in dry eye diabetics: a cross-sectional study in Shenyang, China.BMJ open · 2023Article
- Corneal wound healing and nerve regeneration by novel ophthalmic formulations based on cross-linked sodium hyaluronate, taurine, vitamin B6, and vitamin B12.Frontiers in pharmacology · 2023Article
- Citicoline: pharmacological and clinical review, 2022 update.Revista de neurologia · 2022Review
- Artificial Tears: Biological Role of Their Ingredients in the Management of Dry Eye Disease.International journal of molecular sciences · 2022Review
- Diabetic Corneal Neuropathy: Pathogenic Mechanisms and Therapeutic Strategies.Frontiers in pharmacology · 2022Review
- A Review of Topical and Systemic Vitamin Supplementation in Ocular Surface Diseases.Nutrients · 2021Review
- [The role of citicoline in glaucoma].Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft · 2021Review
- Citicoline in Ophthalmological Neurodegenerative Disease: A Comprehensive Review.Pharmaceuticals (Basel, Switzerland) · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 2 countries.
Funding
Abstract
backgroundTo evaluate the effects of topical citicoline and vitamin B12 (Cit-B12: OMK2, Omikron Italia srl, Italy) on corneal innervation of patients with diabetic neuropathy.
methodsThis prospective, randomized, double blind, placebo-controlled study included 30 patients randomised with a 2:1 ratio to Cit-B12 or placebo 3 times daily for 18 months. 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). 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.
results29/30 patients concluded the study. The two groups had similar FLD at baseline; it progressively improved up to month 18 in both groups (Cit-B12, p < 0.0001; controls, < 0.0001-0.03); improvement at month 18 vs baseline was higher in Cit-B12 than placebo (33% vs 15%, p = 0.04). A progressive amelioration of corneal sensitivity (baseline, 28 ± 18 mm; month 18, 52 ± 10 mm, p < 0.0001), conjunctival staining (P = 0.04) and OSDI questionnaire (P = 0.05) were shown on Cit-B12 group alone. Both treatments were well tolerated and adherence during the study was high.
conclusionsCit-B12 ameliorated both morphology and function of corneal nerves in patients with diabetes, thus suggesting a neuroregenerative effect.
trial registrationTrial registration NCT03906513 , retrospectively registered on 08 April 2019.
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Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.