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Effectiveness of a Dietary Supplement Containing Hydrolyzed Collagen, Chondroitin Sulfate, and Glucosamine in Pain Reduction and Functional Capacity in Osteoarthritis Patients.
Puigdellivol, J, Comellas Berenger, C, Pérez Fernández, MÁ, Cowalinsky Millán, JM, Carreras Vidal, C, Gil Gil, I, Martínez Pagán, J, Ruiz Nieto, B, Jiménez Gómez, F, Comas Figuerola, FX, et al
Journal of dietary supplements. 2019;(4):379-389
Abstract
This observational, open, multicenter clinical trial with a single treatment group aimed to evaluate the effectiveness of a dietary supplement whose main ingredients are hydrolyzed gelatin, chondroitin sulfate, glucosamine sulfate, and devil's claw and bamboo extracts for pain reduction and improvement of functional capacities in patients with osteoarthritis (OA) of the knee and/or hip (REDART study). In all, 130 patients with OA recruited from Spanish hospitals received the dietary supplement for 6 months. The primary outcome was the patients' global assessment of pain in the affected joint as measured with a visual analogue scale (VAS). Other outcome measurements included the Lequesne Functional Index (subindexes for pain/discomfort, distance walked, and daily living) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC; subindexes for pain, stiffness, and physical function). Scores were taken at months 3 and 6 of the treatment. Patients (N = 78) showed a reduction of pain of 3.77 ± 1.77 points after 6 months (p < .0001) in the VAS. The total reduction in the Lequesne Functional Index was 6.30 ± 4.08 points after 6 months (p < .0001), with significant reductions in all subindexes of the scale. A similar pattern was found for the WOMAC index, with an overall reduction of 22.49 ± 14.03 points after 6 months (p < .0001) and significant reductions in all subindexes. No major adverse events were noted during the treatment. This exploratory study shows that treatment with the dietary supplement significantly reduces pain and improves locomotor function in patients with OA of the knee and/or hip.
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Corneal crosslinking without epithelial removal.
Stulting, RD, Trattler, WB, Woolfson, JM, Rubinfeld, RS
Journal of cataract and refractive surgery. 2018;(11):1363-1370
Abstract
PURPOSE To evaluate the effect of riboflavin-ultraviolet (UV)-A corneal crosslinking (CXL) without epithelial removal on ectatic corneal disease. SETTING Woolfson Eye Institute, Atlanta, Georgia, USA. DESIGN Prospective observational study. METHODS Patients were treated with a new riboflavin formulation without epithelial removal, then exposed to UV light (365 nm) at 4 mW/cm2 with on-off cycling for 30 minutes. Uncorrected (UDVA) and corrected (CDVA) distance visual acuities, maximum corneal curvature (maximum keratometry [Kmax]), total higher-order aberrations (HOAs), and coma were measured at 3, 6, 12, and 24 months postoperatively. Progression was defined as an increase of more than 1 diopter (D) in Kmax and loss of more than 1 line of CDVA. RESULTS Five hundred twelve eyes of 308 patients with keratoconus or forme fruste keratoconus and 80 eyes of 55 patients with ectasia after laser in situ keratomileusis (LASIK) were treated with the new riboflavin formulation without epithelial removal; 229 patients received bilateral treatments, 95 of which were simultaneous. The mean UDVA and CDVA improved by 1 to 1.5 Snellen lines at 1 and 2 years postoperatively (P < .0001). Mean Kmax decreased by 0.48 D at 2 years postoperatively (P = .0002). Mean total HOAs and coma decreased by 36% (P < .0001) and 37% (P = .0002), respectively, at 2 years postoperatively. Kmax decreased more than 1 D in three times as many eyes as it increased more than 1 D (P < .0001). No eyes progressed, and there was no loss of effect between 1 and 2 years postoperatively. No vision-threatening events were observed. Pain typically resolved within 24 hours, and visual acuity returned to preoperative levels in 1 to 2 days. CONCLUSION Epithelium-on CXL using this new protocol halted the progression of keratoconus and ectasia after LASIK. It was safer and provided more rapid visual recovery than CXL with epithelial removal, allowing routine bilateral, simultaneous treatment.
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Sustainability of Pain Relief After Corneal Collagen Cross-Linking in Eyes With Bullous Keratopathy.
Ono, T, Mori, Y, Nejima, R, Ogata, M, Minami, K, Miyata, K
Asia-Pacific journal of ophthalmology (Philadelphia, Pa.). 2018;(5):291-295
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Abstract
PURPOSE This study aimed to examine the efficiency and sustainability of pain relief produced by corneal collagen cross-linking (CXL) in eyes with bullous keratopathy (BK) and to explore the histopathological changes in the stroma by using in vivo confocal microscopy. DESIGN Prospective observational case series. METHODS Fourteen eyes of 14 consecutive BK patients were treated with CXL with dehydration of the corneal stroma and followed up for 1 year after treatment. The best-corrected visual acuity (BCVA), intraocular pressure, and central corneal thickness (CCT) were examined before the treatments and up to 1 year after. The intensity and frequency of pain were graded on a scale from 0 (minimum) to 10 (maximum). At 1 year after CXL, the corneal stroma was observed using confocal microscopy at depths of 100 and 200 μm. RESULTS The BCVA and CCT did not change significantly. The mean pain intensity and frequency scores were 5.6 and 4.6, respectively, before treatment. The intensity score significantly decreased at 1 week and onward, and the frequency score significantly decreased over 6 months after treatment. The confocal microscopy images showed that keratocytes and nerve fibers were rare and sparsely distributed in the stroma 1 year after CXL. CONCLUSIONS The CXL efficiently relieved pain due to BK for 1 year after treatment. The in vivo confocal microscopy observations and unchanged CCT demonstrated that the persistence of pain relief was due to the inadequate regeneration of nerve fibers in the corneal stroma.
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Ocular Surface Disease Parameters After Collagen Cross-Linking for Keratoconus.
Recalde, JI, Acera, A, Rodríguez-Agirretxe, I, Sánchez-Tena, MA, San-Cristóbal, J, Durán, JA
Cornea. 2017;(2):148-152
Abstract
PURPOSE To analyze the variations in tear quantity and quality after corneal collagen cross-linking (CXL) in patients with keratoconus. METHODS This is a prospective observational study of 24 eyes with keratoconus that underwent epithelium-off CXL. The variables studied were tear film osmolarity, subjective symptoms (Ocular Surface Disease Index), tear breakup time, Schirmer test (SCH) score, tear clearance, fluorescein staining, and lissamine green staining. Variables were determined preoperatively and 3, 6, and 12 months after CXL. RESULTS All the studied variables remained stable after 1-year follow-up (no significant difference in comparison with baseline values; Mann-Whitney U test). There was a positive paired correlation between the SCH score and tear clearance at 3; 0.532 (P < 0.01), 6; 0.434 (P = 0.04), and 12 months; 0.675 (P < 0.01). There was no correlation between the SCH score and tear breakup time, apart from a positive correlation at 12 months; 0.601 (P = 0.05). A negative correlation was found between osmolarity and the SCH score at 3; -0.589 (P < 0.01) and 12 months; -0.049 (P = 0.04). The Ocular Surface Disease Index did not correlate with any of the studied variables (Spearman test). CONCLUSIONS CXL, at least during the first postoperative year, does not modify the parameters currently used to evaluate tear film function. There is no correlation between objective and subjective parameters in the analysis of the tear film function.
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Conventional and Iontophoresis Corneal Cross-Linking for Keratoconus: Efficacy and Assessment by Optical Coherence Tomography and Confocal Microscopy.
Jouve, L, Borderie, V, Sandali, O, Temstet, C, Basli, E, Laroche, L, Bouheraoua, N
Cornea. 2017;(2):153-162
Abstract
PURPOSE To compare the efficacy, safety, and microstructural corneal changes during 2 years after conventional corneal collagen cross-linking (C-CXL) and transepithelial corneal CXL by iontophoresis (I-CXL) for keratoconus. METHODS Eighty eyes of 80 patients with progressive keratoconus were treated by C-CXL (n = 40) or I-CXL (n = 40). Patients were investigated before surgery and 1, 3, 6, 12, and 24 months after treatment. We measured central corneal thickness and maximal simulated keratometry values (Kmax) and performed specular microscopy and in vivo confocal microscopy at each time point. The demarcation line was assessed 1 month after treatment. RESULTS Kmax remained stable after I-CXL during the entire study period (P = 0.56), whereas the average keratometry increased by 0.2 diopter (50.9 ± 5.6-51.1 ± 5.2). Kmax significantly decreased 1 (P = 0.02) to 2 years (P < 0.01) after C-CXL, with an average decrease of 1.1 diopters (49.9 ± 4.5-48.8 ± 4.2). The failure rate of I-CXL was 20% and that of C-CXL 7.5%. The demarcation line was superficially visible in 35% of cases after I-CXL compared with 95% of cases after C-CXL. Endothelial cell density and central corneal thickness remained stable during the entire study period. The change in Kmax 2 years after C-CXL and I-CXL and the preoperative Kmax were negatively correlated (r = 0.14, P = 0.013, and r = 0.17, P = 0.007, respectively). CONCLUSIONS I-CXL halted progression of keratoconus less efficiently than did C-CXL after 2 years of follow-up. Longer prospective studies are still needed to ensure I-CXL efficacy.
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Corneal Cross-Linking in Pediatric Patients With Progressive Keratoconus.
Wise, S, Diaz, C, Termote, K, Dubord, PJ, McCarthy, M, Yeung, SN
Cornea. 2016;(11):1441-1443
Abstract
PURPOSE To evaluate corneal cross-linking (CXL) in the treatment of keratoconus in pediatric patients. Specifically, this study investigates the impact of CXL on uncorrected distance visual acuity (UDVA), best-corrected distance visual acuity (BDVA), manifest refraction, keratometry (K) measurements, and higher order aberrations. METHODS This is a retrospective, observational case series of patients 18 years old or younger with progressive keratoconus who underwent CXL from January 2009 to August 2013. Preoperative and 1-year postoperative data including BDVA, manifest refraction, mean K readings, and corneal aberration measurements were extracted from clinical charts and topographical imaging. Visual acuity was converted to logarithm of the minimum angle of resolution (logMAR) scale, and mean refractive spherical equivalent (MRSE) was calculated from manifest refraction. RESULTS The group consisted of 39 eyes from 28 patients, including 21 males and 7 females (mean age = 16.3 years, range: 11-18, standard deviation [SD] = 1.81). UDVA did not change significantly (preoperative UDVA = 1.20 logMAR, SD = 0.57, and postoperative UDVA = 0.90 logMAR, SD = 0.67, P = 0.19). BDVA did not change significantly (preoperative BDVA = 0.34 logMAR, SD = 0.27, and postoperative BDVA = 0.34 logMAR, SD = 0.23, P = 0.50). There was no significant change in mean K (preoperative K = 48.49, SD = 5.44, and postoperative K = 48.25, SD = 4.74, P = 0.34). Mean MRSE did not change significantly (preoperative MRSE = -3.29 D, SD = 4.04, and postoperative MRSE = -3.53 D, SD = 4.07, P = 0.31). Corneal aberration measurements were available for 10 eyes, and stability of measurements was demonstrated. There were no complications noted. CONCLUSIONS This study suggests that CXL is a safe and effective procedure that halts the progression of keratoconus in pediatric patients at 1-year follow-up. To validate these findings, longer follow-up is required.
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Corneal Nerve Regeneration After Collagen Cross-Linking Treatment of Keratoconus: A 5-Year Longitudinal Study.
Parissi, M, Randjelovic, S, Poletti, E, Guimarães, P, Ruggeri, A, Fragkiskou, S, Wihlmark, TB, Utheim, TP, Lagali, N
JAMA ophthalmology. 2016;(1):70-8
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Abstract
IMPORTANCE It is unknown whether a neurotrophic deficit or pathologic nerve morphology persists in keratoconus in the long term after corneal collagen cross-linking (CXL) treatment. Nerve pathology could impact long-term corneal status in patients with keratoconus. OBJECTIVE To determine whether CXL treatment of keratoconus results in normalization of subbasal nerve density and architecture up to 5 years after treatment. DESIGN, SETTING, AND PARTICIPANTS Observational study of 19 patients with early-stage keratoconus indicated for a first CXL treatment with longitudinal follow-up to 5 years postoperatively (examinations were performed from 2009 to 2015; analysis was performed from February to May 2015) and 19 age-matched healthy volunteers at a primary care center and a university hospital ophthalmology department. EXPOSURE The patients with keratoconus underwent standard epithelial-off UV-A/riboflavin CXL treatment with 30-minute UV-A exposure at 3 mW/cm2 irradiance. MAIN OUTCOMES AND MEASURES Central corneal subbasal nerve density and subbasal nerve architecture by use of laser-scanning in vivo confocal microscopy; subbasal nerve analysis by 2 masked observers and by use of a fully automated method; wide-field mosaics of subbasal nerve architecture by use of an automated method; and ocular surface touch sensitivity by use of contact esthesiometry. RESULTS Mean (SD) age of the 19 patients with keratoconus was 27.5 (7.1) years (range, 19-44 years), and minimal corneal thickness was 428 (36) μm (range, 372-497 μm). Compared with the mean (SD) preoperative subbasal nerve density of 21.0 (4.2) mm/mm2 in healthy corneas, the mean (SD) preoperative subbasal nerve density of 10.3 (5.6) mm/mm2 in the corneas of patients with stage 1 or 2 keratoconus was reduced 51% (mean difference, 10.7 mm/mm2 [95% CI, 6.8-14.6 mm/mm2]; P < .001). After CXL, nerves continued to regenerate for up to 5 years, but nerve density remained reduced relative to healthy corneas at final follow-up (mean reduction, 8.5 mm/mm2 [95% CI, 4.7-12.4 mm/mm2]; P < .001) despite recovery of touch sensitivity to normal levels by 6 months. Preoperatively, more frequent nerve loops, crossings, and greater crossing angles were observed in the corneas of patients with keratoconus compared with healthy corneas. Postoperatively, the frequency of nerve looping increased, crossings were more frequent, and nerve tortuosity increased. Wide-field mosaics indicated persistent disrupted orientation of the regenerating subbasal nerves 5 years after CXL. CONCLUSIONS AND RELEVANCE Keratoconus is characterized by a neurotrophic deficit and altered nerve morphology that CXL treatment does not address, despite providing a positive biomechanical effect in the stroma. Given the widespread use of CXL in the management of patients with keratoconus, the progression of abnormal innervation after CXL should be recognized.
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Intense Early Flattening After Corneal Collagen Cross-linking.
Santhiago, MR, Giacomin, NT, Medeiros, CS, Smadja, D, Bechara, SJ
Journal of refractive surgery (Thorofare, N.J. : 1995). 2015;(6):419-22
Abstract
PURPOSE To report two cases of significant flattening after corneal cross-linking (CXL) for keratoconus and discuss its potential explanations and implications. METHODS Observational case report. RESULTS One year after standard CXL protocol (3 mW/cm(2) for 30 minutes and total energy of 5.4 J/cm(2)), a 28-year-old woman presented a flattening of greater than 14 diopters and a 14-year-old boy presented a flattening of 7 diopters. CONCLUSIONS Although rare, a significant flattening effect may occur during the first year after CXL, probably related to intense wound healing, increase in corneal elasticity, CXL effective depth, and central cone location. These cases suggest the necessity of a patient-specific approach and a better understanding regarding the actual mechanism behind its potent effect.
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Lower bone turnover markers in metabolic syndrome and diabetes: the population-based Study of Health in Pomerania.
Lerchbaum, E, Schwetz, V, Nauck, M, Völzke, H, Wallaschofski, H, Hannemann, A
Nutrition, metabolism, and cardiovascular diseases : NMCD. 2015;(5):458-63
Abstract
BACKGROUND AND AIMS Accumulating evidence demonstrates an important interaction between bone and energy metabolism. We aimed to study the associations of three bone turnover markers (BTM: osteocalcin, beta-crosslaps, procollagen type 1 N-terminal propeptide) as well as of 25-hydroxyvitamin D and parathyroid hormone with metabolic syndrome (MetS) or type 2 diabetes mellitus (T2DM) in a large population-based cohort. METHODS AND RESULTS This cross-sectional study comprised 2671 adult men and women participating in the first follow-up of the population-based Study of Health in Pomerania (SHIP-1). Multivariable logistic regression analyses were performed to assess sex-specific associations between the BTMs, 25-hydroxyvitamin D or parathyroid hormone and metabolic disease. All models were adjusted for age, body mass index, smoking status, physical activity, estimated glomerular filtration rate and month of blood sampling. The models for women were further adjusted for menopausal status. Higher BTM or 25-hydroxyvitamin D concentrations were associated with significantly lower odds for metabolic disease, while there was no association between parathyroid hormone and MetS or T2DM. CONCLUSION Our results contribute to the accumulating evidence of a cross-sectional association between high BTM or 25-hydroxyvitamin D concentrations and a lower prevalence of MetS or T2DM. Further research is necessary to evaluate the mechanisms underlying these results.
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Variability of different reference bodies in normal, keratoconus, and collagen crosslinked corneas.
Labiris, G, Giarmoukakis, A, Rampotas, A, Symeou, M, Bougatsou, P, Sideroudi, H, Kozobolis, VP
European journal of ophthalmology. 2015;(6):468-73
Abstract
PURPOSE To evaluate the reproducibility of different Scheimpflug imaging-derived reference bodies in normal, keratoconus (KC), and crosslinked (CXL) eyes. METHODS In this prospective, observational study, 40 participants populated the control group (CG), while 33 and 34 patients formed the KC group and the CXL group, respectively. One eye was randomly selected when both were eligible. Elevation measurements were obtained using Scheimpflug camera, by applying the following reference bodies: the best fit sphere (BFS), the best fit toric ellipsoid (BFTE), the best fit toric ellipsoid with fixed eccentricity of 0.4 (BFTEF), the best fit ellipsoid (BFE), and the best fit torus, by 2 operators in 2 sessions. The variability of different reference bodies' parameters was assessed using intraclass correlation coefficient (ICC). RESULTS Differences between operators were nonsignificant for all reference bodies' parameters in all study groups (p>0.1). Regarding CG, BFS for both operators and BFTE for operator 1 presented the best intrasession repeatability (majority of ICCs >0.90), while average interobserver reliability was recorded for the majority of reference bodies' parameters. Regarding KC and CXL groups, BFS, BFTEF, and BFE reference bodies demonstrated the best intrasession and interobserver reproducibility (majority of ICCs >0.90) for both groups. Steep and flat radius parameters presented the best overall reproducibility, with the majority of ICCs for all reference bodies ranging above 0.90, in all study groups. CONCLUSIONS High variability was encountered for most reference surfaces. Ellipsotoric surfaces presented acceptable repeatability in KC and post-CXL corneas.