vitamin-b-12 and Dry-Eye-Syndromes

Our purpose is to demonstrate the changes in cornea nerve parameters and symptoms and signs in dry eye disease (DED) patients after oral vitamin B1 and mecobalamin treatment. In this randomized double-blind controlled trial, DED patients were randomly assigned to either the treatment group (oral vitamin B1 and mecobalamin, artificial tears) or the control group (artificial tears). Corneal nerve parameters via in vivo confocal microscopy (IVCM), DED symptoms, and signs were assessed at baseline and 1 and 3 months post-treatment. In total, 398 eyes from 199 patients were included. In the treatment group, there were significant improvements in corneal nerve length, width, and neuromas, the sign of conjunctival congestion score (CCS), symptoms of dryness, pain, photophobia, blurred vision, total symptom score, and OSDI (OSDI) at 1/3 months post-treatment (all p < 0.05). Patients who received vitamin B1 and mecobalamin showed greater improvement in CCS, dryness scores at 1 month (p < 0.05), corneal fluorescein staining (CFS) (p = 0.012), photophobia (p = 0.032), total symptom scores (p = 0.041), and OSDI (p = 0.029) at 3 months. Greater continuous improvement in CFS (p = 0.045), dryness (p = 0.033), blurred vision (p = 0.031) and total symptom scores (p = 0.023) was demonstrated at 3 months than at 1 month post-treatment in the treatment group. We found that oral vitamin B1 and mecobalamin can improve corneal nerve length, width, reflectivity and the number of neuromas in IVCM, thereby repairing epithelial cells and alleviating some ocular symptoms. Thus, vitamin B1 and mecobalamin are potential treatment options for patients with DED.

Topics: Cornea; Dry Eye Syndromes; Fluoresceins; Humans; Lubricant Eye Drops; Microscopy, Confocal; Neuroma; Photophobia; Tears; Thiamine; Vitamin B 12

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.. This 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.. 29/30 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.. Cit-B12 ameliorated both morphology and function of corneal nerves in patients with diabetes, thus suggesting a neuroregenerative effect.. Trial registration NCT03906513 , retrospectively registered on 08 April 2019.

Topics: Cornea; Cytidine Diphosphate Choline; Diabetes Mellitus; Diabetic Neuropathies; Dry Eye Syndromes; Humans; Prospective Studies; Tears; Vitamin B 12

Topics: Aged; Cohort Studies; Cornea; Dry Eye Syndromes; Female; Humans; Male; Microscopy, Confocal; Middle Aged; Oxytocin; Prospective Studies; Vitamin B 12

Increased levels of oxidative stress have been seen in animal models of dry eye and in the conjunctival epithelial cells of patients with Sjögren's syndrome. The aims of this study were to compare the levels of oxidative stress in patients with dry eye and patients without dry eye and to evaluate the effects of treatment with preservative-free eye drops containing hyaluronic acid 0.15 % and vitamin B12 on oxidative stress and dry eye symptoms.. Three cohorts of patients who were to undergo planned cataract surgery were enrolled: patients with dry eye randomized to either no treatment (n = 29) or treatment (n = 32) with hyaluronic acid/vitamin B12 eye drops, and patients without dry eye (n = 42). Patients were assessed by Schirmer's type I test, fluorescein clearance test (FCT), Break Up Time (BUT), and Ocular Surface Disease Index (OSDI). Lipid peroxidation, a marker of oxidative stress, was assessed by LP-CHOLOX test.. Compared with patients without dry eye, patients with dry eye had significantly increased levels of oxidative stress, higher OSDI and FCT scores, and significantly lower Schirmer's test and BUT scores. Treatment with eye drops containing hyaluronic acid 0.15 % and vitamin B12 was associated with significantly reduced levels of oxidative stress and OSDI and FCT scores and significantly increased Schirmer's test and BUT scores.. These findings indicate that oxidative stress is associated with dry eye and that hyaluronic acid/vitamin B12 eye drops may attenuate oxidative stress and inflammation, improving dry eye symptoms. Further study in controlled clinical trials is warranted.

Topics: Administration, Topical; Aged; Conjunctiva; Drug Combinations; Dry Eye Syndromes; Epithelium; Female; Humans; Hyaluronic Acid; Lipid Peroxidation; Male; Ophthalmic Solutions; Osmolar Concentration; Oxidative Stress; Preservatives, Pharmaceutical; Prospective Studies; Tears; Viscosupplements; Vitamin B 12; Vitamin B Complex

To study the treatment efficacy of hyaluronic acid 0.3%, cyanocobalamin (vitamin B12), electrolytes, and P-Plus in menopausal patients with moderate dry eye disease.. Thirty female patients of mean age 53.06 ± 5.20 years (45-65) were enrolled in this prospective longitudinal study. Meibomian gland loss assessment was determined using a scale with four levels. The Ocular Surface Disease Index (OSDI) questionnaire, phenol red thread (PRT) test, and tear film break-up time (TFBUT) were also completed by the patients. Tear eye drops were formulated with 0.3 g of sodium hyaluronate, P-Plus ™, vitamin B12, sodium chloride, potassium chloride, calcium chloride, magnesium chloride, and SCO® (stabilized complex oxychloride). After 30 days, the patients were re-evaluated.. The mean meibomian gland loss percentage was 37.97 ± 19.02 % (7.20 to 88.30%). Before treatment, the OSDI was 22.53 ± 14.03 score points (6.25 to 77.08). Posterior OSDI decreased to 16.26 ± 13.69 score points (0.00 to 70.83) (W = 58.00, P < 0.01). Before treatment, PRT was 10.31 ± 4.48 mm (4.00 to 21.00). Posterior PRT increased to 15.41 ± 6.27 mm (4.00 to 21.00) (W = 1520.50, P < 0.01). Before treatment, TFBUT was 6.23 ± 1.75 s (3.00 to 9.00). The posterior TFBUT increased to 8.10 ± 2.06 s (4.00 to 14.00) (W= 1382.50, P < 0.01).. The hyaluronic acid 0.3% and vitamin B12 eye drops effectively decreased dry eye symptoms in menopausal women and improved tear stability and volume.

Topics: Dry Eye Syndromes; Electrolytes; Female; Humans; Hyaluronic Acid; Longitudinal Studies; Menopause; Middle Aged; Prospective Studies; Tears; Vitamin B 12

The commitment of the existent study was to develop a mucoadhesive in situ gel systems of vitamin B12 for the management of dry eye disease. The gels were prepared using pluronic F-127 and either of chitosan, carbapol 971P, sodium alginate, or hydroxy propyl methyl cellulose. Drug-excipients compatibility was investigated by means of differential scanning calorimetry and Fourier transform infrared spectroscopy. The gels were characterized for pH, clarity, gelling capacity, viscosity, and adhesion. In vitro release of vitamin B12 from the selected gels was investigated. In vivo effectiveness of the selected gel was determined in rabbit models using Schirmer's and fluorescein tests. The compatibility studies revealed the possibility of incidence of drug/polymer interaction in some formulations. F2-containing pluronic F127 and hydroxypropyl methyl cellulose showed the most appropriate physical characterization and in vitro release profile. The prepared gels showed prolonged drug release with drug release mechanism of combined diffusion and erosion. The in vivo study revealed good effectiveness of the prepared mucoadhesive in situ gel system of vitamin B12 in the treatment of dry eye disease that was comparable to that of the marketed drops.

Topics: Adhesives; Animals; Drug Compounding; Drug Delivery Systems; Drug Liberation; Dry Eye Syndromes; Excipients; Female; Gels; Hypromellose Derivatives; Male; Mucous Membrane; Poloxamer; Rabbits; Viscosity; Vitamin B 12; Vitamins

This study aims to understand the effect of vitamin B12 deficiency on neuropathic ocular pain (NOP) and symptoms in patients with dry eye disease (DED).. Patients with severe DED (without receiving topical artificial tears treatment) and ocular pain were enrolled (n = 90). Patients with severe DED and vitamin B12 deficiency (group 1, n = 45) received parenteral vitamin B12 supplement + topical treatment (artificial tears treatment + cyclosporine), and patients with severe DED and normal serum vitamin B12 level (group 2, n = 45) received only topical treatment (artificial tears treatment + cyclosporine). Patients were evaluated by the ocular surface disease index (OSDI) questionnaire, 3rd question (have you experienced painful or sore eyes during last week?) score of OSDI as a pain determiner and pain frequency measure), tear break up time (TBUT), and Schirmer's type 1 test. We compared the groups' OSDI, TBUT, and Schirmer's test recordings at the first visit and after 12 weeks retrospectively.. The OSDI score, 3rd OSDI question score, TBUT, and Schirmer's test results improved after 12 weeks (p < 0.001 for each group). The mean vitamin B12 level at enrollment was 144.24 ±43.36 pg/ml in group 1 and 417.53 ±87.22 pg/ml in group 2. The mean vitamin B12 level in group 1 reached to 450 ±60.563 pg/ml after 12 weeks of treatment. The mean score changes between the groups were not statistically significant; however, the decrease in the OSDI questionnaire score (-30.80 ±5.24) and 3rd OSDI question score (-2.82 ±0.53) were remarkable in group 1 (Table 2). The mean TBUT increase was +7.98 ±2.90 s and Schirmer's test result increase was +12.16 ±2.01 mm in group 1. The mean TBUT increase was +6.18 ±1.49 s and Schirmer's test result increase was +6.71 ±1.47 mm in group 2.. These findings indicate that vitamin B12 deficiency is related with NOP. It may be important to consider measuring the serum vitamin B12 level in patients with severe DED presenting with resistant ocular pain despite taking topical treatment.

Topics: Administration, Topical; Adult; Chronic Pain; Dry Eye Syndromes; Eye Pain; Female; Follow-Up Studies; Humans; Lubricant Eye Drops; Male; Retrospective Studies; Treatment Outcome; Vitamin B 12; Vitamin B 12 Deficiency; Vitamin B Complex

To compare plasma homocysteine levels between patients with dry eye disease and normal control subjects.. Plasma homocysteine (enzyme immunoassay), vitamin B12, and folate levels were determined in 38 patients with dry eye and in 38 controls.. Characteristics of the dry eye and control groups were similar. The mean plasma homocysteine level was 16.38 ± 6.98 μmol/L in the dry eye group and 14.39 ± 5.11 μmol/L in the control group (P = 0.10, t test). Hyperhomocysteinemia was present in the 43.9% of the dry eye patients and 33.3% of the controls (P = 0.43, χ test). There were no statistical differences between dry eye and control groups regarding plasma vitamin B12 and folate levels (P = 0.72 and P = 0.69, respectively, t test).. Plasma homocysteine levels in dry eye patients may be inadequate to give homocysteine a role in pathogenesis. However, in ocular diseases like glaucoma, plasma homocysteine levels are significantly higher, and associated dry eye disease may cause an additional increase in plasma homocysteine levels.

Topics: Dry Eye Syndromes; Female; Folic Acid; Homocysteine; Humans; Hyperhomocysteinemia; Immunoenzyme Techniques; Luminescent Measurements; Male; Middle Aged; Prospective Studies; Surveys and Questionnaires; Vitamin B 12