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Safety and efficacy of riboflavin-assisted collagen cross-linking of cornea in progressive keratoconus patients: A prospective study in North East India.
Bhattacharyya, A, Sarma, P, Das, K, Agarwal, B, Medhi, J, Das Mohapatra, SS
Indian journal of pharmacology. 2019;(3):157-167
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INTRODUCTION Riboflavin- and ultraviolet (UV)-A-mediated collagen cross-linking of the cornea is a frequently used therapeutic measure for the treatment of progressive keratoconus (PK). First, riboflavin increases cross-linking and second, it serves as a protective shield to other deep ocular structures. However, pharmacogenomic variation in riboflavin efficacy is reported. As the Northeast Indian population represents a genetically diverse group of population compared to mainstream India, we have assessed the efficacy of the procedure in a northeastern population with PK. METHODS In this study, 78 eyes with PK were included (n = 39 in the treatment arm and n = 39 in the control arm). The primary objective was to evaluate the effect of corneal collagen cross-linking using riboflavin (C3R) (epithelium off) on maximum keratometry. The secondary objectives were evaluation of change in corneal topography parameters, i.e., minimum keratometry (Kmin), simulated keratometry (Sim K), subjective refraction (cylinder power, spherical power, and spherical equivalent [SE]), uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), and contrast sensitivity (CS) and safety (intraocular pressure, endothelial cell density, and percentage hexagonality) at 1, 3, and 6 months following C3R procedure. RESULTS Statistically significant improvement was noted in Kmin (6 months), Sim K (3 and 6 months), cylinder power (3 and 6 months), spherical power (3 and 6 months), SE (3 and 6 months), BCVA (6 months), and UCVA (1, 6 months) in the C3R group (n = 39) when compared to the control group (n = 39). The mean CS decreased at 1 month and gradually improved to achieve statistically significant value at 6 months in the C3R group (P < 0.05). CONCLUSION Riboflavin-assisted C3R treatment showed promising efficacy in the treatment of PK patients in our population. As the collagen turnover rate of cornea is 2-3 years and the progression of PK is highly variable, we need long-term studies to evaluate the efficacy of C3R over time, requirement of repeat therapy, and safety of repeat cross-linking.
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Oral administration of 5-aminolevulinic acid induces heme oxygenase-1 expression in peripheral blood mononuclear cells of healthy human subjects in combination with ferrous iron.
Ito, H, Nishio, Y, Hara, T, Sugihara, H, Tanaka, T, Li, XK
European journal of pharmacology. 2018;:25-33
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Heme oxygenase-1 (HO-1) is a major anti-inflammatory enzyme and a key regulator that induces immune tolerance through affecting the differentiation of dendritic cells. The aim of this study is to determine whether the combination of 5-aminolevulinic acid (ALA) and iron induces HO-1 expression in healthy human peripheral blood mononuclear cells (PBMC). The study was an open labeled, non-randomized, non-placebo-controlled trial using healthy male adults and consisted of three parts. Study A aimed to find the peak HO-1 expression at 0, 1, 2, 3, 4, 6, 8, 12, 16, and 24 h after administration. Study B aimed to examine HO-1 dose dependency at 150, 300, and 600 mg of ALA and the need for iron supplementation. Study C aimed to investigate HO-1 changes during a three-day, repetitive administration of ALA and iron. The combination of ALA 600 mg and sodium ferrous citrate (SFC) 942 mg upregulated HO-1 in PBMC at 8 h after administration while sole administration of ALA or SFC was unable to induce HO-1. HO-1 in blood myeloid and plasmacytoid dendritic cells was also upregulated with ALA+SFC. Clear dose dependency of ALA+SFC was not detected, and a slight tendency towards a cumulative effect of HO-1 after three-day, repetitive administration was observed. ALA, which is already approved for use in several countries as a diagnosis agent for cancer, has the potential to become a novel therapeutic drug for diseases stemming from unwanted immune response such as autoimmune diseases and the rejection response following organ transplantation.
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Morphological and functional correlations in riboflavin UV A corneal collagen cross-linking for keratoconus.
Mazzotta, C, Caporossi, T, Denaro, R, Bovone, C, Sparano, C, Paradiso, A, Baiocchi, S, Caporossi, A
Acta ophthalmologica. 2012;(3):259-65
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PURPOSE To investigate the correlations between corneal structural modifications assessed by in vivo corneal confocal microscopy with visual function [uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA)] and morphological data (corneal topography, pachymetry, elevation analysis) after riboflavin UV A corneal collagen cross-linking (CXL) for the stabilization of progressive keratoconus. METHODS Forty-four eyes with progressive keratoconus were enrolled in the Siena Eye Cross Study (prospective nonrandomized phase II open trial). All eyes underwent Riboflavin UV A CXL. Preoperative and postoperative evaluation comprised: UCVA, BSCVA, optical pachymetry (Visante OCT, Zeiss, Germany), corneal topography (CSO, Florence, Italy) and tomography (Orbscan IIz; B&L, Rochester, NY, USA) and in vivo confocal microscopy (Heidelberg Retina Tomograph II; Rostock, Heidelberg Gmbh, Germany). Examinations were performed preoperatively 6 months and one day before treatment and at 1, 3, 6 and 12 months of follow-up. RESULTS In vivo corneal confocal microscopy showed time-dependent postoperative epithelial and stromal modifications after cross-linking. Epithelial thinning associated with stromal oedema and keratocytes apoptosis explained initial tendency towards slightly reduced VA and more glare one month postoperatively in 70% of eyes. Furthermore, a statistically not significant early worsening of topographic mean K values was observed. Orbscan II analysis significantly underestimated pachymetric values after treatment. Pachymetric underestimation was rectified by high-resolution optical pachymetry provided by the Visante OCT system. After the third post-CXL month, epithelial thickening, disappearance of oedema and new collagen compaction recorded by in vivo corneal confocal microscopy explained the improvements in visual performance during the follow-up. Changes in stromal reflectivity and collagen compaction observed by in vivo confocal microscopy were associated with corneal flattening and reduction in anterior elevation values recorded by differential topographic analysis. CONCLUSION Corneal structural changes assessed by in vivo corneal confocal microscopy demonstrated significant correlations with visual function (UCVA and BSCVA) and morphological (corneal topography, pachymetry, elevation analysis) findings recorded after riboflavin-UV A-induced CXL.
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Clinical and corneal biomechanical changes after collagen cross-linking with riboflavin and UV irradiation in patients with progressive keratoconus: results after 2 years of follow-up.
Goldich, Y, Marcovich, AL, Barkana, Y, Mandel, Y, Hirsh, A, Morad, Y, Avni, I, Zadok, D
Cornea. 2012;(6):609-14
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PURPOSE To assess the biomechanical and keratometric effects and the safety of treatment of progressive keratoconus with UV-riboflavin collagen cross-linking (CXL). METHODS This is a prospective clinical controlled study. Fourteen eyes of 14 patients with progressive keratoconus were treated with CXL after corneal deepithelization. Patients were assessed preoperatively, at week 1 and at months 1, 3, 6, 9, 12, and 24 after treatment. We measured uncorrected visual acuity (UCVA) and best spectacle-corrected visual acuity (BSCVA) (logarithm of the minimum angle of resolution), refraction, biomicroscopy and fundus examination, intraocular pressure, axial length, endothelial cell density, corneal topography, minimal corneal thickness, macular optical coherence tomography, and corneal biomechanics with the ocular response analyzer. RESULTS Comparing the preoperative results with 24-month postoperative results, we observed significant improvement in BCVA (0.21 ± 0.1 to 0.14 ± 0.1, P = 0.002) and stability in UCVA (0.62 ± 0.5 and 0.81 ± 0.49, P = 0.475). We observed a significant decrease in steepest-meridian keratometry (diopters) (53.9 ± 5.9 to 51.5 ± 5.4, P = 0.001) and in mean cylinder (diopters) (10.2 ± 4.1 to 8.1 ± 3.4, P = 0.001). Significant elongation of the eyes was observed, from 24.39 ± 1.7 mm to 24.71 ± 1.9 mm (P = 0.007). No significant change was observed in mean simulated keratometry, minimal corneal thickness, endothelial cell density, corneal hysteresis, and corneal resistance factor or foveal thickness. CONCLUSIONS Two years after CXL, the observation of stable UCVA, improved BCVA, and reduced keratometry suggests stabilization in progression of keratoconus. Unchanged corneal thickness, endothelial cell density, and foveal thickness suggest the long-term safety of this procedure. The observed increase in axial length and stability in corneal biomechanical parameters measured with the ocular response analyzer require further study for verification and explanation.
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Prospective clinical trial evaluating the efficacy of photodynamic therapy for symptomatic circumscribed choroidal hemangioma.
Boixadera, A, García-Arumí, J, Martínez-Castillo, V, Encinas, JL, Elizalde, J, Blanco-Mateos, G, Caminal, J, Capeans, C, Armada, F, Navea, A, et al
Ophthalmology. 2009;(1):100-105.e1
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PURPOSE To evaluate photodynamic therapy (PDT) for symptomatic circumscribed choroidal hemangioma (CCH). DESIGN Prospective, multicenter, nonrandomized clinical trial. PARTICIPANTS Thirty-one eyes of 31 patients with posterior pole CCH and symptoms caused by exudation into the macular area. INTERVENTION Photodynamic therapy was applied by Zeiss laser. Intravenous verteporfin at 6 mg/m(2) body surface was administered before treatment, and light emitted at 689 nm for photosensitization. The treatment spot diameter was calculated on early-phase frames of pretreatment indocyanine green angiography. Fifteen minutes after starting the verteporfin infusion, the laser beam was applied to the retina at radiant exposure 50 J/cm(2) and exposure time 83 seconds. One to 4 treatments were applied at 12-week intervals over 1 year. Standardized evaluation was performed before and at 4-week intervals after each treatment, and at 3, 6, 9, and 12 months. All patients were followed for >or=12 months. MAIN OUTCOME MEASURES The primary outcome measure was the absence of exudative retinal detachment at the 12-month follow-up visit on ophthalmoscopy, fluorescein angiography, and optical coherence tomography. Secondary measures were the visual acuity outcome, with best-corrected visual acuity determined by the Early Treatment for Diabetic Retinopathy Study chart, tumor thickness decrease on B-scan ultrasonography, and adverse events. RESULTS Among the total, 82.8% of patients required 1, 13.8% 2, and 3.4% 3 PDTs to eliminate exudative retinal detachment. Visual acuity increased from a mean of 20/60 to 20/35 (P<0.001). Sixty-nine percent of patients demonstrated visual recovery (P<0.001). Cystoid macular edema regressed in all cases and exudative macular detachment disappeared in all but 2 cases. The CCH thickness decreased in all cases from a mean of 3.0 to 1.7 mm, with the most intense effect seen after 4 weeks of treatment (P<0.001). Visual fields showed resolution of central scotomas. There were no severe adverse events. CONCLUSIONS Combining PDT with the standard age-related macular degeneration protocol is an effective treatment for CCH in terms of resolution of exudative subretinal fluid and recovery of VA. FINANCIAL DISCLOSURE(S): The authors have no proprietary or commercial interest in any materials discussed in this article.