Effect of a Fixed Combination of Curcumin, Artemisia, Bromelain, and Black Pepper Oral Administration on Optical Coherence Tomography Angiography Indices in Patients with Diabetic Macular Edema.

Background: To investigate the effects of a fixed combination of Curcumin (200 mg), Artemisia (80 mg), Bromelain (80 mg), and Black pepper (2 mg) on vascular parameters in mild to moderate diabetic macular edema (DME). Design: Prospective, case-control study. Methods: Fifty-six patients affected by diabetes mellitus type II were enrolled in the study. Twenty-eight patients with DME received 2 tablets/day, before meals of a dietary complementary supplement containing in fixed combination Curcumin (200 mg), Artemisia (80 mg), Bromelain (80 mg), and Black pepper (2 mg) (Intravit®, OFFHEALTH Spa, Firenze, Italy) for 6 months. Twenty-eight age-matched subjects affected by diabetes mellitus type II were given placebo and served as control group. Patients underwent best correct visual acuity (BCVA), swept optical coherence tomography (OCT), and OCT-Angiography (OCTA). OCTA images of the superficial capillary plexus (SCP) and deep capillary plexus (DCP) were obtained for each eye. By the end of the follow-up patients were defined responder to the therapy when a decrease of more than 30 µm was registered in central retinal thickness (CRT) measurement, while a poor responder was determined by the absence of reduction or an increase in central retinal thickness at 6 months. We assessed the foveal avascular zone (FAZ) area, vessel density and quantified the number of microaneurysms in each layer. Results: A significant improvement of BCVA and CRT reduction was recorded at 6 months follow-up in the dietary complementary supplementation group compared to control (respectively p = 0.028 and p = 0.0003). VD of the total capillary plexus, microaneurysms count, glycaemia and HbA1c did not vary over the follow-up period between groups. Within the Intravit® group, poor responders tended to show a larger FAZ area, more microaneurysms, and a lower VD in the DCP compared to the good responders group (p < 0.0001). Conclusions: A fixed combination of Curcumin, Artemisia, Bromelain, and Black pepper oral administration may have a positive impact on central retinal thickness, visual acuity, and VD of the DCP in compensated type 2 diabetic patients with mild DME.

Effects of Citicoline, Homotaurine, and Vitamin E on Contrast Sensitivity and Visual-Related Quality of Life in Patients with Primary Open-Angle Glaucoma: A Preliminary Study.

The aim of the present study was to evaluate the effects of supplementation with a fixed combination of citicoline 500 mg, homotaurine 50 mg, and vitamin E 12 mg (CIT/HOMO/VITE) on contrast sensitivity and visual-related quality of life in patients with primary open-angle glaucoma (POAG) in mild stage. This was a multicenter, observational, cross-over, short-term, pilot study on POAG patients with stable controlled intraocular pressure (IOP). Patients were randomly assigned to Group 1 (current topical therapy for 4 months and then current topical therapy plus CIT/HOMO/VITE for 4 months) or Group 2 (CIT/HOMO/VITE in addition to current topical therapy for 4 months and then topical therapy alone for 4 months). Best-corrected visual acuity, IOP, visual field, and the Spaeth/Richman contrast sensitivity (SPARCS) test score were recorded at baseline and after 4 and 8 months. The Glaucoma Quality of Life-15 (GQL-15) questionnaire was administered at each check time. Forty-four patients were assigned to Group 1 and 65 to Group 2. Over the follow-up period, there were no significant changes in IOP or visual field findings, whereas SPARCS and GQL-15 findings significantly varied from baseline, both being improved in subjects treated with CIT/HOMO/VITE fixed combination. These results demonstrate that a daily intake of a fixed combination of citicoline, homotaurine, and vitamin E in addition to the topical medical treatment significantly increased the total score of the contrast sensitivity test and the quality of life in patients with POAG.

Treatment of exudative age-related macular degeneration with aflibercept combined with pranoprofen eye drops or nutraceutical support with omega-3: A randomized trial.

AIMS: The aim of this study was to determine whether a combination of intravitreal aflibercept (IVA) and pranoprofen eyedrops or nutraceutical support provides additional benefit over IVA monotherapy for the treatment of choroidal neovascularization (CNV) in age-related macular degeneration. METHODS: This was a prospective, randomized, pilot study in 60 patients with treatment-naïve CNV. Patients were randomized 1:1:1 into three groups: aflibercept monotherapy (AM), aflibercept plus pranoprofen (AP) or aflibercept plus nutraceutical (AN) tablets containing multivitamin antioxidant and mineral supplementation plus omega-3. RESULTS: At 12 months, all groups showed significant improvement in both best-corrected visual acuity (BCVA) and central retinal thickness (CRT). The mean BCVA change from baseline to 12 months was -0.26 ± 0.06 LogMAR, -0.30 ± 0.06 LogMAR and -0.24 ± 0.04 LogMAR in the AM, AP and AN groups, respectively. The mean CRT change from baseline to 12 months was -76.9 ± 10.9 µm, -129 ± 19.9 µm and -105 ± 11.6 µm in the AM, AP and AN groups, respectively. The AN group required one less IVA injection than the AM group. CONCLUSIONS: Compared with AM, both combination groups acted synergistically, although no significant benefits in BCVA were found over AM. Nutraceutical support with omega-3 leads to a reduced need for IVA.

Effect of palmitoylethanolamide on visual field damage progression in normal tension glaucoma patients: results of an open-label six-month follow-up.

The purpose of this study is to assess the effect of palmitoylethanolamide (PEA) oral administration on intraocular pressure (IOP) and visual field damage progression in normal-tension glaucoma (NTG) patients. Thirty-two consecutive patients affected by NTG were enrolled and randomized in a 1:1 ratio to receive PEA treatment (group A) or no treatment (group B). Group A patients took ultramicronized 300 mg PEA tablets two times per day for six months. Best-corrected visual acuity (BCVA), IOP, and visual field test were evaluated at baseline and at the end of the six-month follow-up. No significant differences in clinical parameters between the two groups were observed at baseline. At six months, group A patients showed significant IOP reduction (from 14.4±3.2 mm Hg to 11.1±4.3 mm Hg, p<0.01). No statistically significant changes were seen in BCVA in either group. Visual field parameters significantly diminished in patients receiving PEA compared to baseline values (-7.65±6.55 dB vs. -4.55±5.31 dB, p<0.001; 5.21±4.08 dB vs. 3.81±3.02 dB, p<0.02; mean deviation [MD] and pattern standard deviation [PSD] respectively), while no significant changes were seen in group B. A generalized linear model demonstrated that the final IOP, MD, and PSD was affected only by the systemic PEA treatment (p<0.01 each) and not affected by demographic or clinical characteristic between the groups. Hence, systemic administration of PEA reduces IOP and improves visual field indices in individuals affected by NTG. Neither ocular nor systemic side effects were recorded during the study period.

Ocular tissues and fluids oxidative stress in hares fed on verbascoside supplement.

The influence of a prolonged diet supplemented with the powerful antioxidant verbascoside on the oxidative state of 20 healthy hares eye fluids and tissues has been studied. Verbascoside was dosed at 2, 3, 4 mg/die and the impact on the oxidative state of ocular tissues and fluids was tested by TBARS (thio barbituric acid reactive substances) and TEAC (trolox equivalent antioxidant capacity) assays. The percentage of change in antioxidant activity increased largely in retina and lenses at a daily verbascoside dose of 3 mg, whereas for optic nerve and vitreous humor the higher antioxidant capacity was measured at 4 mg/die verbascoside dose. The present findings demonstrate that verbascoside supplementation is able to protect ocular tissue and fluids from naturally occurring oxidation and that its protective effect depends on the daily dose, being maximum up to 3 mg/die.

Effects of verbascoside-based diet on blood and plasma constituents of rabbits.

OBJECTIVE: Oxidative stress brought on by free radicals can lead to an increased risk of some chronic pathologies. Antioxidants can scavenge free radicals by turning them into nonradical and nontoxic metabolites. The purpose of this study is to investigate the effect of a phenylpropanoid glycosides-based prolonged diet on blood constituents in animals. METHODS: Tests were carried out on healthy New Zealand white rabbits and the following parameters were evaluated at baseline and after 90 days' follow-up: plasma triglycerides, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, aspartate transaminase, alanine aminotransferase, bilirubin, the reactive oxygen metabolites, thiobarbituric acid-reactive substances, vitamin A, and vitamin E. The same parameters were analyzed in an age- and sex-matched animal control group. RESULTS: We first defined the concept of average rate and then used it to calculate, by experimental data fitting, the formation or destruction rate of some blood or plasma constituents as a function of the daily dose. The results indicate that the effects can be categorized into 2 classes. The first includes the effects that produce monotonously continuous changes with daily dose, and the second includes those that exhibit a saturating trend. CONCLUSIONS: The experimental results suggest that high doses of verbascoside can potentially cause adverse effects through prooxidative effects. Risk is increased by the use of pharmacological doses of polyphenols in prevention, treatment, and as dietary supplements.

Twenty-three-gauge pars plana vitrectomy, Densiron-68, and 360° endolaser versus combined 20-gauge pars plana vitrectomy, scleral buckle, and SF6 for pseudophakic retinal detachment with inferior retinal breaks.

PURPOSE: To compare the anatomical and functional outcomes of 23-gauge pars plana vitrectomy (PPV) with Densiron-68 tamponade and 360° endolaser versus 20-gauge PPV with encircling scleral buckling (ESB) and an SF6 gas tamponade for the repair of primary pseudophakic retinal detachment with inferior retinal breaks. METHODS: Prospective, randomized, comparative, interventional study. Eighty-two eyes of 82 consecutive patients were randomly assigned to 1 of the 2 treatment groups: 23-gauge PPV/Densiron-68 (44 eyes, 54%) or 20-gauge PPV/ESB/SF6 (20%) (38 eyes, 46%). The inclusion criterion was the presence of primary pseudophakic retinal detachment with at least 1 retinal break between the 4- and 8-o'clock positions. The study protocol involved a minimum of 7 visits: baseline, day of surgery, 1 week, and 1, 3, 6, and 9 months postoperation. Densiron-68 removal was performed within 12 weeks of the initial surgery. Two surgical procedures were required in the Densiron group to remove the oil. RESULTS: After the primary procedure, the retina was reattached in 90% (40 of 44) of cases in the 23-gauge PPV/Densiron group and in 92% (35 of 38) of cases in the 20-gauge PPV/ESB/SF6 group (P = 0.2, Fisher's exact test). After resolution of redetachments, final anatomical success rate rose to 97% (43 of 44) in the 23-gauge PPV/Densiron group and 94% (36 of 38) in the 20-gauge PPV/SB/SF6 group (P = 0.32, Fisher's exact test). Mean final best-corrected visual acuity (logarithm of the minimum angle of resolution) was 0.40 in the 23-gauge PPV/Densiron group and 0.48 in the 20-gauge PPV/ESB/SF6 group (P = 0.31, t-test). Operative time was significantly less in the 23-gauge PPV/Densiron group (P = 0.002, t-test). No statistically significant difference in the complication rate between the two groups was recorded. CONCLUSION: Twenty-three-gauge PPV combined with Densiron-68 and 360° endolaser and 20-gauge PPV combined with ESB/SF6 seemed to have similar efficacy in the repair of primary pseudophakic retinal detachment. Supplementary scleral buckling can be avoided using a Densiron-68 tamponade for retinal detachment with inferior retinal breaks.

The influence of diclofenac ophthalmic solution on the intraocular pressure-lowering effect of topical 0.5% timolol and 0.005% latanoprost in primary open-angle glaucoma patients.

The aim of this randomized, prospective, masked clinical study has been to verify the influence of a non-steroidal anti-inflammatory drug ophthalmic solution on intraocular pressure reduction induced by 0.5% timolol and 0.005% latanoprost eyedrops in patients affected by primary open-angle glaucoma. Thirty-two glaucomatous patients, compensated with 0.5% timolol, were randomized into two study groups (A and B). Timolol was continued for the first 2 weeks in all subjects. On the 15th day, in both groups timolol was replaced by latanoprost, and this regimen lasted up to the end of the follow-up (8 weeks). At the beginning of the 2nd week of the study, group A additionally started a 5-week therapy with topical 0.1% diclofenac; during the same period, group B received placebo eyedrops with identical modalities. Intraocular pressure was recorded at 7-day intervals during the first 7 weeks and at the 10th week. Non-steroidal anti-inflammatory drug and placebo did not modify the effect of timolol on intraocular pressure. In both groups, latanoprost induced a significant decrease in intraocular pressure. Diclofenac-treated patients exhibited a marked fall in intraocular pressure (p<0.01), whereas in placebo-treated patients, this diminution was less noticeable (p<0.05). After diclofenac withdrawal, in group A intraocular pressure significantly increased (p<0.01), remaining approximately at the same level up to the end of the study. In group B, at the same checks no significant variations in intraocular pressure occurred. In primary open-angle glaucoma patients, diclofenac significantly enhances the hypotensive effect of latanoprost, without influence on timolol efficacy. Because non-steroidal anti-inflammatory drugs are widely employed in medical practice, supplementary ophthalmologic checks should be scheduled during the co-administration of these compounds and prostaglandin analogues.