A pilot clinical study on the effectiveness of mesoglycan against diabetic retinopathy.

PURPOSE: A double-blind placebo-controlled study on 68 patients suffering by Diabetic Retinopathy was aimed in order to evaluate the effectiveness of Mesoglycan in this pathology. This drug is particularly interested in treatment of disorders of microcirculation. MATERIALS AND METHODS: The two treatments were randomly assigned to each patient, using a 100 mg/day dosage of Mesoglycan, and both treatments were prescribed for 6 months. The efficacy of both treatments was based on clinical and instrumental check. RESULTS: The clinical results that emerged in the group treated with Mesoglycan were excellent, although observations are on a limited number of patients appears a direct action of Mesoglycan on the endothelium retinal blood vessels and circulation. Indeed, in the observed patients, was detected a significant reduction of microhemorrhages, microaneurysms and exudates. The same cannot be said of the placebo group; none of patients of that group showed signs of clinical improvement at the end of the study. CONCLUSION: Data emerging from our study show a direct action of Mesoglycan on endothelium retinal blood vessels and circulation, as we observed in patients we found a significant reduction in the number of microhemorrhages, microaneurysms and exudates. This action can be explained by the characteristics of drug as antithrombotic profibrinolytic and anti-edema, already found in vitro and experimentally. We conclude that our preliminary study showed an encouraging clinical efficacy, together with excellent tolerability, and therefore our objective has been met, which was to verify the existence of the prerequisites for a larger clinical study.

Improvement of visual functions and fundus alterations in early age-related macular degeneration treated with a combination of acetyl-L-carnitine, n-3 fatty acids, and coenzyme Q10.

The aim of this randomized, double-blind, placebo-controlled clinical trial was to determine the efficacy of a combination of acetyl-L-carnitine, n-3 fatty acids, and coenzyme Q10 (Phototrop) on the visual functions and fundus alterations in early age-related macular degeneration (AMD). One hundred and six patients with a clinical diagnosis of early AMD were randomized to the treated or control groups. The primary efficacy variable was the change in the visual field mean defect (VFMD) from baseline to 12 months of treatment, with secondary efficacy parameters: visual acuity (Snellen chart and ETDRS chart), foveal sensitivity as measured by perimetry, and fundus alterations as evaluated according to the criteria of the International Classification and Grading System for AMD. The mean change in all four parameters of visual functions showed significant improvement in the treated group by the end of the study period. In addition, in the treated group only 1 out of 48 cases (2%) while in the placebo group 9 out of 53 (17%) showed clinically significant (>2.0 dB) worsening in VFMD (p = 0.006, odds ratio: 10.93). Decrease in drusen-covered area of treated eyes was also statistically significant as compared to placebo when either the most affected eyes (p = 0.045) or the less affected eyes (p = 0.017) were considered. These findings strongly suggested that an appropriate combination of compounds which affect mitochondrial lipid metabolism, may improve and subsequently stabilize visual functions, and it may also improve fundus alterations in patients affected by early AMD.

Pilot study to evaluate the efficacy and safety of pneumatic trabeculoplasty in glaucoma and ocular hypertension.

PURPOSE: Following laser-assisted in situ keratomileusis (LASIK), intraocular pressure (IOP) is measurably lower in a significant number of cases. It has been proposed that the decrease in IOP may be a real event. Prior trials have evaluated pneumatic trabeculoplasty (PNT) in combination with concomitant glaucoma medications. The aim of this study was to determine the efficacy and the safety of PNT alone to lower IOP in patients with primary open angle glaucoma (POAG) or ocular hypertension (OH). METHODS AND RESULTS: A total of 37 subjects with POAG or OH were enrolled in a prospective, open-label, fellow-eye, multicenter trial to determine the IOP lowering effects of PNT. All subjects underwent ophthalmologic examinations and IOP measurements and were washed out from all glaucoma medications prior to the start of the study. The trial was intrapatient controlled for the first 30 days, with one eye receiving PNT at days 0 and 7 and the fellow eye serving as the control. The second eye was treated with PNT at day 30. The patients were followed for 120 days, with the first eye receiving an additional PNT treatment at days 90 and 97. Two analyses-an intent to treat analysis in which the last IOP measurement for patients dropped from the study was carried forward and an analysis including only those patients who completed the trial-were performed. Of the 37 patients enrolled, 27 (73%) completed the study. For the intent to treat analysis the baseline mean IOP was 24.7+/-1.9 mmHg for eye 1 and 23.6+/-2.3 mmHg for eye 2 and the difference was statistically significant (p<0.05). Using this analysis the differences between eye 1 mean IOP at days 1, 7, 14, and 60 and the baseline mean IOP were statistically significant (p<0.05). The differences between eye 2 mean IOP and the baseline mean IOP were statistically significant (p<0.05) at all time points except day 14 and day 30. The greater mean IOP reductions from the baseline mean IOP for eye 1 were at study day 1 (-16,1%), day 14 (-9%), and day 60 (-8.9%). For eye 2 they were at day 60 (-8.7%) and at day 120 (-9.1%). For the analysis that included only those subjects who completed the trial the decrease in eye 1 mean IOP from baseline was statistically significant (p<0.05) at all time points. The decrease in eye 2 mean IOP from baseline was statistically significant at all time points except day 30. Using this analysis the greater mean IOP reductions from the baseline mean IOP for eye 1 were at study day 1 (-19%), day 14 (-15.7%), day 37 (-16.3%), day 60 (-20.0%), day 90 (-18.1%), day 97 (-16.8%), and day 120 (-15.8%). For eye 2 greater mean IOP reductions from baseline mean IOP were seen on day 37 (-13.0%), day 60 (-16.7%), day 90 (-15.5%), day 97 (-14.5%), and day 120 (-7.2%). No statistically significant differences were found in mean IOP reduction between the two eyes treated. A total of 34 patients (92%) showed adverse effects: conjunctival hyperemia in 26 (70.3%) and conjunctival hemorrhage in 14 (37.8%). CONCLUSIONS: This pilot study of PNT showed a potentially good IOP lowering effect on glaucoma and hypertensive patients. Additional studies would help to better define the types of patients who respond to PNT and to identify risk factors that may lead to treatment failure.

Frequency distribution of dextromethorphan O-demethylation in a Greek population.

OBJECTIVE: To determine the CYP2D6 phenotype in a Greek population by using dextromethorphan (DM) as a probe drug. METHODS: DM (30 mg) was given orally to 102 unrelated Greek subjects and 8-hour urine samples were collected. Concentrations of DM and its metabolite dextrorphan (DX) were determined using a validated HPLC assay. Metabolic molar ratio (MR) of DM to free DX in log form was used as an in vivo index of metabolic status. RESULTS: The frequency distribution histogram of MR was bimodal. An antimode of 0.25 for the mean log MR was determined using probit analysis. Seven of 102 subjects (6.9%) were poor metabolizers (PMs). CONCLUSION: The PM frequency of CYP2D6 in Greek subjects was similar to other Caucasian populations.

Antioxidant activity of flavonoids from Sideritis raeseri.

Nine 7-o-allosyl glucosides of 5,8-dihydroxy substituted flavones were isolated from a fraction of the methanol extract of the aerial parts of Sideritis raeseri Boiss et Heldr. subsp. raeseri. The structures were identified by spectroscopic methods. The antioxidant activity of this fraction, evaluated by the Co(II) EDTA-induced luminol chemiluminescence and by the DPPH scavenging activity, was found to be moderate. The activity can be related with the presence of 5- and 8-o-disubstituted flavones.

Mitotropic compounds for the treatment of age-related macular degeneration. The metabolic approach and a pilot study.

Recent histopathologic studies have shown that mitochondria and peroxisomes of the retinal pigment epithelium may play a central role in the pathophysiology of age-related macular degeneration (AMD). We supposed that compounds which improve mitochondrial functions (mitotropic compounds) may show beneficial effects in preventing AMD. Fourteen patients affected by early AMD were treated with a mixture containing acetyl-L-carnitine (ALC), polyunsaturated fatty acids (PUFAs), coenzyme Q10 (CoQ10) and vitamin E, while an equal number of age- and sex-matched patients affected by early AMD were treated with vitamin E only. Recovery time after macular photostress, foveal sensitivity and mean defect in the visual field as well as blood lipid levels were recorded at the beginning and after 3, 6, 9, 12 and 24 months of follow-up. In the treated group, all the visual functions showed slight improvement which was evident after 3 months of treatment and remained nearly stationary by the end of 24 months. The same tests in the control group showed slow worsening. The divergence between treated and control groups became more marked with time, but the difference was not significant at any time of the follow-up. These findings suggest that the blend of ALC, PUFA, CoQ10 and vitamin E may improve retinal functions in early AMD.

A new acetylated glucoside of luteolin and two flavone glucosides from Lavandula stoechas ssp. stoechas.

Fractionation of ethyl acetate extract of Lavandula stoechas aerial parts revealed the presence of a novel acetylated glucoside (1) together with apigenin 7-O-glucoside (2) and luteolin 7-O-glucoside (3). The structures of these compounds were elucidated by spectroscopic analyses, notably UV, MS, and NMR.

MTHFR C677T mutation, factor II G20210A mutation and factor V Leiden as risks factor for youth retinal vein occlusion.

OBJECTIVE: To determine whether methylene tetrahydrofolate reductase (MTHFR) C677T mutation, factor II G20210A mutation and factor V Leiden are risk factors for retinal vein occlusion (RVO) in patients under fifty years of age. METHODS: Comparison of 29 patients, under 50 years old of age, as affected RVO and 62 age matched normal controls. Plasma MTHFR C677T genotype, Factor II G20210A genotype, Factor V Leiden genotype, S protein level, C protein level, APCR presence (Actived Protein C Resistance), homocysteine level and Beta-thromboglobulin level were determined. RESULTS: Seventeen RVO patients and twenty-one controls were heterozygous for the MTHFR C677T mutation. Three RVO patients and twenty-three controls were homozygous for the MTHFR C677T mutation. Three RVO patients and two controls were heterozygous for the factor II G20210A mutation. One control was heterozygous for the factor V Leiden. CONCLUSIONS: This study fails to demonstrate that these mutations are risk factors for RVO in patients under fifty years of age.

A new method of biofeedback in the management of low vision.

Twenty-eight patients with low vision were enrolled into the study. A preliminary study was carried out on 18 eyes of 13 patients with low vision who underwent visual rehabilitation with a new instrument for biofeedback (BF) applied to vision; improved biofeedback integrated system (Ibis). Successively, eight patients (16 eyes) with bilateral low vision were subjected to biofeedback in one eye. The experimental and control eye were evaluated separately. Then a placebo training was developed on seven patients (12 eyes). Visual acuity, colour vision, automated perimetry, contrast sensitivity and flash VEP were evaluated. A brief review of the literature and the possible mechanisms behind the results are discussed.

Element concentrations and cataract: an experimental animal model.

The determination of inorganic ions in cataractous human lenses has been the subject of several investigations; nevertheless, few studies have been concerned with trace element contents in lenses, and data are sometimes contradictory. An animal experimental model of induced cataract is here proposed with the aim of evaluating the changes of Ca, Na, K, Cu and Zn concentrations. The cataract was produced by an Nd:YAG Laser treatment of the right eye of sexteen male rabbits. The determination of the elements was performed by atomic absorption spectrometry (both flame and flameless methods) after an acid digestion of samples. Compared with the results obtained in left lenses used as a control (Ca 14.4+/-5.7 mg/kg d.w.; Na 1.3+/-0.5 g/kg d.w.; K 9.9+/-1.1 g/kg d.w.; Cu 0.24+/-0.09 mg/kg d.w.; Zn 24.8+/-2.3 mg/kg d.w.), the mean concentration values of opaque lenses showed some significant changes for Ca, Na, and Cu (Ca 123.7+/-106.6 mg/kg d.w.; Na 4.5+/-4.3 g/kg d.w; Cu 0.43+/-0.21 mg/kg d.w.). Potassium showed a tendency to decrease, and zinc to increase. Positive correlations were found between calcium and sodium both in controls (r=0.73, p<0.001) and in treated lenses (r= 0.87, p<0.0001). An inverse correlation between Ca and K confirmed the tendency of potassium to decrease.

Subjective visual halos after sildenafil (Viagra) administration: Electroretinographic evaluation.

PURPOSE: The ophthalmologic and electroretinographic (ERG) findings in one subject with subjective visual disturbances after sildenafil administration are described. DESIGN: Interventional case report. METHODS: A complete ophthalmologic examination was performed, including best-corrected visual acuity and ERG, repeated 1 and 2 hours after administration of 100 mg of sildenafil. MAIN OUTCOME MEASURES: Rod responses were obtained over a range of retinal illuminances from those producing a minimum detectable response to those producing rod saturation. Intensity amplitude function was determined. RESULTS: At 2 hours after 100 mg of oral sildenafil, we observed significant variations from baseline in parameters of best-fit Naka-Rushton function; V(max) was notably higher, and K was 0.14 log units lower than baseline. CONCLUSIONS: Sildenafil administration resulted in a higher rod response to light stimuli and in a higher rod sensitivity. These findings are consistent with the weak PDE-6 inhibition induced by sildenafil.

Use of Erbium:YAG laser in the treatment of palpebral xanthelasmas.

OBJECTIVE: In light of the research and the use of lasers in the therapy of xanthelasmas, the authors report their experience in the treatment of this pathology with Erbium:YAG laser. MATERIALS AND METHODS: In 30 patients, all female, 70 xanthelasmas were treated with Erbium:YAG laser, 65 (93%) of which were on the upper eyelid and 5 (7%) on the lower eyelid, varying from 1 x 1.5 mm to 11 X 20 mm in size. Spots with a diameter of 1.6 mm, energy of 300 mJ, frequency of 1-5 Hz and in a number varying were used in relation to the extent of the pathology. RESULTS: In all cases, the appearance and functional results were good, without leaving scars and/or dyschromia. CONCLUSIONS: Erbium:YAG laser, in the treatment of xanthelasmas, is a parasurgical method that is simple to perform and because of the successful aesthetic and functional results, is a valid alternative to the more traditional treatment methods.

Transient visual symptoms in systemic lupus erythematosus and antiphospholipid syndrome.

PURPOSE: To review the potential pathogenic mechanisms of transient visual symptoms (TVS) in the course of systemic lupus erythematosus (SLE) and antiphospholipid syndrome (APS), to discuss the most common clinical features associated with the occurrence of TVS, and to explore possible treatment options for these patients. METHODS: The literature regarding the clinical and laboratory characteristics of SLE and APS patients experiencing TVS is reviewed from 1979 onward. A brief review of the wide spectrum of ophthalmologic features occurring in SLE and APS is also provided. RESULTS: Data emerging from the review process point to thromboembolism as the most probable cause of TVS in SLE and APS. Thromboembolisms are likely induced by cardiac valve abnormalities and should be treated with anticoagulant drugs. CONCLUSION: While progress has been made in understanding the association of TVS with SLE and APS, further investigation is needed to clarify this interesting relationship.

Excimer laser photorefractive keratectomy for hyperopia.

BACKGROUND AND OBJECTIVE: Photorefractive keratectomy (PRK) has been extensively evaluated for the correction of myopia. This study was undertaken to assess the safety, efficacy, and reliability of PRK in the correction of hyperopia. PATIENTS AND METHODS: There were 28 eyes with refractions of +1 to +7.75 D treated for hyperopia with the Chiron Technolas 217-C excimer laser. Thorough visual assessments were made before treatment and at regular follow-up to 18 months. Complications and patient satisfaction were noted. RESULTS: At 18 months the mean subjective refraction was +0.46+/-1.00 D with 26 eyes (92.8%) within 1 D of emmetropia. Thirteen eyes (46.4%) achieved uncorrected visual acuity (UCVA) of 20/20 or better and all patients had an UCVA of > or = 20/32 or better. Best corrected visual acuity (BCVA) remained unchanged in 26 eyes (92.8%) and improved in 2 eyes (7.2%). On the seventh day from treatment, 17 eyes (25%) had a loss of 2 or more lines of BCVA. At 15 days this was reduced to 8 eyes (14.3%) and at one month to 3 eyes (3.6%). There were no cases of loss of 2 or more lines of BCVA at 18 months of follow-up. All patients expressed a high degree of satisfaction. CONCLUSIONS: Photorefractive keratectomy safely and effectively reduced hyperopia in the patients studied. The technique was reliable and still offered good results at 18 months of follow-up.

Retinopathy in systemic lupus erythematosus: pathogenesis and approach to therapy.

The starting point in the assessment of SLE-retinopathy is the clinical examination by ophthalmoscopy and retinal fluorescein angiography. It is noted that two major clinical forms of retinopathy may occur in SLE; (1st) the "classic" type characterized by cotton-wool spots with or without intraretinal hemorrhages, and (2nd) the thrombosis of larger retinal blood vessels, such as central or branch arteries/veins. However, a well-defined pathogenetic classification of SLE-retinopathy has still not been proposed as yet. A practical classification based on the pathogenesis could be of aid to commence a more appropriate treatment. The aims of this paper are; (1st) to focus on the most implicate mechanisms of retinal vascular disease in SLE, (2nd) to mention the most common features associated with the different forms of retinopathy, and finally (3rd) to assess the prevalence of retinopathy in SLE. In our opinion, it seems that two major types of retinopathy exist in SLE: firstly, the Hughes' retinopathy due to antiphospholipid-induced retinal vascular thrombosis, for which anticoagulation is the best treatment, and secondly, the "classic" retinopathy in which at least two major causes could be associated; vasculitis and accelerated atherosclerosis. In patients with "classic" retinopathy, the most appropriate treatment still needs to be established. If "classic" retinopathy is due to vasculitis, immunosuppressive drugs should be administered, while if atherosclerosis play an etiologic role, a prophylaxis with antioxidants or the use of low-dose aspirin should be assessed.

Excimer laser photorefractive keratectomy for high myopia and myopic astigmatism.

BACKGROUND AND OBJECTIVE: To determine the efficacy, safety, and predictability of excimer laser photorefractive keratectomy of high myopia and myopic astigmatism. PATIENTS AND METHODS: 76 eyes of 52 patients with myopia from -8.00 to -23.50 diopters (D) with or without astigmatism up to -5.50D were treated with the VISX 20/20 excimer laser (VISK, Santa Clara, CA) and a multi-zone ablation technique. Visual acuity, manifest refraction, corneal haze, and topography were evaluated at 1 week and 1, 3, 6, 12, and 18 months postoperatively. RESULTS: Postoperative refractions were generally stable after 12 months. At the last follow-up all patients were within - 1.96 D of the intended correction. Eighteen months postoperatively, 68% of patients undergoing photorefractive keratectomy (PRK), and 65% of patients undergoing photo astigmatic refractive keratectomy (PARK), were within 1 D of planned refraction. Furthermore, 87% of patients after PRK and 80% of patients after PARK had a visual acuity of 20/40 or better. CONCLUSIONS: High myopia with or without astigmatism was successfully treated in most of the patients using PRK. The stability of the postoperative refraction during the first 18 months seems to be good. The incidence of adverse effects was low but improvements in the future should further reduce complications, thus increasing the safety of refractive procedures.

Optic neuropathy in systemic lupus erythematosus and antiphospholipid syndrome (APS): clinical features, pathogenesis, review of the literature and proposed ophthalmological criteria for APS diagnosis.

Optic neuropathy is a well-known ocular manifestation occurring in patients with systemic lupus erythematosus (SLE), and it remains one of the major causes of blindness in these patients. We report data from six SLE patients with optic neuropathy, one of whom was considered to have antiphospholipid syndrome (APS). This patient had monolateral optic neuropathy, whereas the other five SLE patients had bilateral optic nerve disease. We believe that the monolateral occurrence of optic neuropathy in our patient can be considered as a 'focal' neurological disease due to a thrombotic event involving the ciliary vasculature. Conversely, bilateral optic nerve damage in SLE could be considered to be a 'general' neurological disease due to different immunological mechanisms, such as vasculitis. Additionally, the literature on SLE patients affected by optic neuropathy is reviewed to evaluate the major clinical features, particularly neurological features. In reviewing the literature, it appears that bilateral optic neuropathy in SLE occurs more frequently than monolateral optic neuropathy, and the main neurological manifestation seen in these patients is transverse myelitis, particularly in SLE patients with bilateral optic nerve disease. Finally, we propose a clinico-ophthalmological spectrum of APS and outline the ocular clinical manifestations that can be considered as diagnostic for the syndrome.