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Corneal collagen cross-linking with and without simultaneous intrastromal corneal ring segment implantation: One-year pilot study.
Sharma, IP, Bakshi, R, Chaudhry, M
European journal of ophthalmology. 2021;(1):61-68
Abstract
AIM: The aim of this study was to assess and compare the visual, refractive, and topographic outcomes of keratoconic eyes treated with corneal collagen cross-linking combined with and without same day intrastromal corneal ring segment over the first 12 months. METHODS This prospective randomized study analyzed 38 eyes of 30 consecutive keratoconus patients aged 26.21 ± 6.97 (range = 15-41) years. A total of 20 eyes were treated with collagen cross-linking alone, and 18 eyes underwent collagen cross-linking combined with simultaneous femtosecond laser-assisted intrastromal corneal ring segment. Visual acuity, manifest refraction, and corneal topography (using a rotating Scheimpflug topographer) were assessed and compared between the two groups at baseline, 6, and 12 months. RESULTS On an average follow-up duration of 12.2 ± 0.50 (range = 11-13) months, both collagen cross-linking alone and collagen cross-linking with simultaneous intrastromal corneal ring segment implantation were effective. However, collagen cross-linking plus intrastromal corneal ring segment resulted in an additional improvement of uncorrected distance visual acuity of 0.16 (95% confidence interval = 0.01 to 0.32) logarithm of the minimum angle of resolution units (p = 0.035), cylindrical power by 1.16 D (95% confidence interval = 0.25 to 2.06, p = 0.014), and spherical equivalent by 1.40 D (95% confidence interval = -2.71 to -0.08, p = 0.038) at 1 year. During the study period, no serious intraoperative or postoperative complications were noted in either group. CONCLUSION One-year follow-up results suggest that collagen cross-linking with simultaneously combined intrastromal corneal ring segment implantation could yield an additive visual and refractive outcome. The combined procedure is safe and merits consideration for the treatment of progressive keratoconus to achieve better visual rehabilitation.
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The surgical management of the cavity and bone defects in enchondroma cases: A prospective randomized trial.
Nazarova, NZ, Umarova, GS, Vaiman, M, Asilova, SU, Abba, M, Foonberg, M, Shterenshis, M
Surgical oncology. 2021;:101565
Abstract
BACKGROUND We compared the curettage/bone grafting and the curettage/bone graft substitutes surgical techniques in their relation to functional outcomes, oncologic outcome (recurrence, malignant transformation), the rate of postsurgical complications, durations of surgery and of postsurgical immobilization for hand-localized cases of solitary and multiple enchondromas. METHODS The current prospective randomized trial analyzed 200 adult patients (2012-2017) with enchondroma who underwent surgical intervention. The cases were randomly divided into Group 1 (n = 100; F 56, M 44) for surgeries with curettage and autogenous bone grafting, and Group 2 (n = 100; F 55, M 45) for surgeries with curettage and bone graft substitutes. The placebo control Group 3 consisted of cases operated by curettage only (n = 56; F 31, M 25). The follow-up period was set at 30 months. RESULTS The duration of surgery was 51 ± 4 min in Group 1 and 27 ± 1 min in Group 2 (p = 0.008). In Group 1, the rate of recurrence was 6% against 1% in Group 2 (p = 0.005). No other statistically significant differences in postsurgical outcomes between three involved groups were noted. CONCLUSION In cases of enchondroma of the hand, postsurgical functional outcomes, the rate of postsurgical complications, the duration of immobilization, and the time to complete recovery are not influenced by the type of chosen grafting material. The implementation of HAp-collagen bone substitutes in granules instead of autogenous bone grafting reduces the duration of surgery. The implementation of autogenous bone grafting may increase the rate of tumor recurrence.
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Age-Dependent Control of Collagen-Dependent Platelet Responses by Thrombospondin-1-Comparative Analysis of Platelets from Neonates, Children, Adolescents, and Adults.
Herken, K, Glauner, M, Robert, SC, Maas, M, Zippel, S, Nowak-Göttl, U, Zieger, B, Lahav, J, Fender, AC, Jurk, K, et al
International journal of molecular sciences. 2021;(9)
Abstract
Platelet function is developmentally regulated. Healthy neonates do not spontaneously bleed, but their platelets are hypo-reactive to several agonists. The mechanisms underlying immature platelet function in neonates are incompletely understood. This critical issue remains challenging for the establishment of age-specific reference ranges. In this study, we evaluated platelet reactivity of five pediatric age categories, ranging from healthy full-term neonates up to adolescents (11-18 years) in comparison to healthy adults (>18 years) by flow cytometry. We confirmed that platelet hypo-reactivity detected by fibrinogen binding, P-selectin, and CD63 surface expression was most pronounced in neonates compared to other pediatric age groups. However, maturation of platelet responsiveness varied with age, agonist, and activation marker. In contrast to TRAP and ADP, collagen-induced platelet activation was nearly absent in neonates. Granule secretion markedly remained impaired at least up to 10 years of age compared to adults. We show for the first time that neonatal platelets are deficient in thrombospondin-1, and exogenous platelet-derived thrombospondin-1 allows platelet responsiveness to collagen. Platelets from all pediatric age groups normally responded to the C-terminal thrombospondin-1 peptide RFYVVMWK. Thus, thrombospondin-1 deficiency of neonatal platelets might contribute to the relatively impaired response to collagen, and platelet-derived thrombospondin-1 may control distinct collagen-induced platelet responses.
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Accelerated Versus Standard Corneal Cross-Linking for Progressive Keratoconus: A Meta-Analysis of Randomized Controlled Trials.
Kobashi, H, Tsubota, K
Cornea. 2020;(2):172-180
Abstract
PURPOSE To compare the clinical results of accelerated corneal collagen cross-linking (ACXL) to standard corneal collagen cross-linking (SCXL) in progressive keratoconus by summarizing randomized controlled trials using a meta-analysis. METHODS Trials meeting the selection criteria were quality appraised, and data were extracted by 2 independent authors. A comprehensive search was performed using the Cochrane methodology to evaluate the clinical outcomes of ACXL and SCXL for treating progressive keratoconus. Estimates were evaluated by weighted mean difference (WMD) and 95% confidence interval (CI) for absolute changes of the outcomes during 12-month observation periods. Postoperative demarcation line depth was also compared. RESULTS We identified 6 randomized controlled trials that met the eligibility criteria for this meta-analysis. SCXL resulted in a significantly better outcome in postoperative changes in best spectacle-corrected visual acuity (WMD = -0.02; 95% CI, -0.03 to -0.01; P < 0.0001); however, the small differences may not be clinically significant. ACXL provided a significantly better improvement of cylindrical refraction after the 1-year follow-up (WMD = 0.15; 95% CI, 0.05-0.26; P = 0.005). Demarcation line depth at 1 month after SCXL was deeper than that after ACXL (WMD = -102.25; 95% CI, -157.16 to -47.35; P = 0.0003). No differences in the changes in maximum keratometry, central corneal thickness, uncorrected visual acuity, spherical equivalent refraction, corneal biomechanical properties, and corneal endothelial cell density were found among both groups. CONCLUSIONS An ACXL shows a comparable efficacy and safety profile at the 1-year follow-up, but it has less impact on improving best spectacle-corrected visual acuity when compared with the Dresden protocol. Overall, both methods similarly stop the disease progression.
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Standard and accelerated corneal cross-linking long-term results: A randomized clinical trial.
Hashemi, H, Mohebbi, M, Asgari, S
European journal of ophthalmology. 2020;(4):650-657
Abstract
PURPOSE To compare long-term results between accelerated and standard corneal cross-linking protocols in the treatment of progressive keratoconus and compare their effectiveness between central (cone in the central 3 mm) and peripheral (cone beyond 3 mm) cases. METHODS In this randomized clinical trial, we compared 31 eyes treated with accelerated corneal cross-linking (18 mW/cm2, 5 min) and 31 eyes treated with standard corneal cross-linking (3 mW/cm2, 30 min), 16 central and 11 peripheral keratoconus in each group. In this report, 4-year changes in vision, refraction, topography, corneal biomechanics, and corneal cell count were evaluated. RESULTS Uncorrected distance visual acuity improvement was better with standard corneal cross-linking (0.19 ± 0.30 logMAR) than accelerated corneal cross-linking (0.08 ± 0.35 logMAR), but the intergroup difference was not statistically significant (p = 0.283). Cylinder and spherical equivalent significantly increased similarly in both groups. Among topographic indices, anterior Kmax-3 mm showed more reduction in standard corneal cross-linking than accelerated corneal cross-linking (1.35 ± 1.39 vs 0.36 ± 1.10 D, p = 0.011). Anterior Kmax-8 mm reduced by 1.50 ± 1.82 and 0.37 ± 1.58 D in the standard corneal cross-linking and accelerated corneal cross-linking groups, respectively (p = 0.029). Compared to 18-month results, none of the indices at 4 years showed any significant intergroup difference (all p > 0.05). In cases with peripheral keratoconus, changes in anterior Kmax-3 mm (+0.03 ± 0.66 vs -1.17 ± 1.15 D, p = 0.012) and anterior Kmax-8 mm (+0.43 ± 1.09 vs -1.57 ± 1.40 D, p = 0.003) were greater with standard corneal cross-linking. In central cases, no significant intergroup difference was observed. CONCLUSION At 4 years after the procedure, standard corneal cross-linking offered better anterior corneal flattening in the center and periphery. These differences concerned cases of peripheral keratoconus, and the two protocols were similarly effective in central cases. Beyond the 18th month, the two protocols appeared to be similarly effective.
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Effect of calcium and vitamin D supplementation with and without collagen peptides on bone turnover in postmenopausal women with osteopenia.
Argyrou, C, Karlafti, E, Lampropoulou-Adamidou, K, Tournis, S, Makris, K, Trovas, G, Dontas, I, Triantafyllopoulos, IK
Journal of musculoskeletal & neuronal interactions. 2020;(1):12-17
Abstract
OBJECTIVES Collagen peptides (CPs) seem to exert beneficial effects on bone and may have a role as a treatment option. In the present randomized prospective study, we aimed to examine the efficacy, as expressed by changes in P1NP and CTX, and the tolerability of 3-month supplementation of calcium, vitamin D with or without bioactive CPs in postmenopausal women with osteopenia. METHODS Fifty-one female, postmenopausal women with osteopenia were allocated to two groups: Group A received a sachet containing 5 g CPs, 3.6 g calcium lactate (equivalent to 500 mg of elemental calcium) and 400 IU vitamin D3 and group B received a chewable tablet containing 1.25 g calcium carbonate (equivalent to 500 mg of elemental calcium) and 400 IU vitamin D3 daily. RESULTS In group A, the P1NP levels significantly decreased by 13.1% (p<0.001) and CTX levels decreased by 11.4% (p=0.058) within 3 months of supplementation. In group B, P1NP and CTX did not change. Group A presented better compliance in comparison to group B and no adverse events contrary to group B. CONCLUSIONS These findings may reflect the reduction of the increased bone turnover in postmenopausal women with the use of calcium, vitamin D and CPs supplements. The addition of CPs in a calcium and vitamin D supplement may enhance its already known positive effect on bone metabolism. Clinical Trial ID: NCT03999775.
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A prospective, randomized clinical study comparing accelerated corneal collagen crosslinking with 5% NaCl hypertonic saline for bullous keratopathy in Asian eyes.
Kasai, K, Kato, N, Den, S, Konomi, K, Shinzawa, M, Shimazaki, J
Medicine. 2019;(51):e18256
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Abstract
BACKGROUND We compared the clinical outcomes of accelerated corneal collagen crosslinking (CXL) and 5% NaCl hypertonic saline (HS) for the treatment of symptomatic bullous keratopathy (BK). METHODS A randomized controlled trial was held at Department of Ophthalmology, Tokyo Dental College Ichikawa General Hospital, Chiba, Japan. Twenty-three eyes of 23 consecutive patients with symptomatic BK were enrolled. The etiology of BK included pseudophakic BK, previous keratoplasty, previous endotheliitis, previous glaucoma surgery, trauma, herpes infection, as well as unknown causes. Eleven eyes received epi-off accelerated CXL (with epithelial abrasion and 18 mW/cm ultraviolet A irradiation for 5 minutes) and 12 eyes received HS instillation. In addition to the usual ophthalmic examination, the best-corrected visual acuity (BCVA) and central corneal thickness (CCT) were determined. The CCT was measured using anterior segment optical coherence tomography before and up to 6 months after treatments. Subjective symptoms of pain, blurred vision, photophobia, and irritation were also recorded. RESULTS The follow-up was completed for all patients in the CXL group. However, 6 patients in the HS group requested CXL treatments after 3 months. The BCVA was not significantly changed during the study periods in both groups. The CCT was significantly thinner in the CXL group compared to the HS group at 1 and 6 months (P = .015 and 0.144, respectively). Among the subjective symptoms recorded, irritation was significantly lower in the CXL group at 1 month (P = .013). CONCLUSIONS Accelerated CXL may produce transient improvement in pain and corneal edema in patients with BK.
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Prospective Randomized Trial of Corneal Cross-linking Riboflavin Dosing Frequencies for Treatment of Keratoconus and Corneal Ectasia.
Price, MO, Fairchild, K, Feng, MT, Price, FW
Ophthalmology. 2018;(4):505-511
Abstract
PURPOSE To investigate whether the riboflavin dosing frequency affects corneal cross-linking efficacy or safety, given that isotonic riboflavin solution is viscous and each installation coats the corneal surface with a film that absorbs some of the incident ultraviolet A light. DESIGN Prospective, randomized, single-center equivalence trial. PARTICIPANTS Patients with progressive keratoconus or ectasia after refractive surgery (n = 510). METHODS One eye per patient was prospectively randomized to 2-minute or 5-minute riboflavin dosing intervals with standard corneal cross-linking (epithelial removal and 30-minute irradiation with 3 mW/cm2 ultraviolet A light). Block randomization resulted in comparable representation of keratoconus and ectasia after refractive surgery in the 2 treatment arms. Treatment equivalence was assessed using the 2 one-sided test. Fellow eyes (n = 207) were treated with 5-minute dosing and considered in the safety analysis. MAIN OUTCOME MEASURES The primary hypothesis was equivalent change in the topography-derived maximum keratometry value from baseline to 6 months with 2-minute vs. 5-minute dosing. A ±0.75-diopter margin of equivalence for the treatment difference between dosing regimens was considered clinically relevant. Adverse events and changes from baseline to 6 months in corrected distance visual acuity (CDVA), uncorrected distance visual acuity, and minimum corneal thickness were assessed. RESULTS The mean reduction in maximum keratometry from baseline was equivalent with 2-minute and 5-minute riboflavin dosing intervals at 6 months (0.97 and 0.76 diopters, respectively; 90% confidence interval for treatment difference, -0.23 to 0.66; per-protocol population). With both dosing intervals, the mean improvement in CDVA was 0.07 logarithm of the minimum angle of resolution or 3.5 letters at 6 months. Of the 635 study and fellow eyes examined at 6 months, 134 (21%) gained and 32 (5%) lost 2 or more lines of CDVA. Three eyes (0.4%) developed sterile infiltrates, 1 (0.1%) had delayed epithelial healing with dendrites, and 3 (0.4%) had recurrent epithelial defects. Three eyes (0.4%) were re-treated. CONCLUSIONS The 2 riboflavin dosing regimens produced equivalent reduction in the maximum keratometry value, with a favorable safety profile.
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Accelerated versus conventional corneal collagen cross-linking in patients with keratoconus: an intrapatient comparative study.
Sadoughi, MM, Einollahi, B, Baradaran-Rafii, A, Roshandel, D, Hasani, H, Nazeri, M
International ophthalmology. 2018;(1):67-74
Abstract
PURPOSE To compare the outcomes of the conventional and accelerated corneal collagen cross-linking (CXL) in patients with bilateral progressive keratoconus (KC). METHODS Fifteen consecutive patients with bilateral progressive KC were enrolled. In each patient, the fellow eyes were randomly assigned to the conventional CXL (3 mW/cm2 for 30 min) or accelerated CXL (ACXL) (9 mW/cm2 for 10 min) groups. Manifest refraction; uncorrected and corrected distant visual acuity; maximum and mean keratometry; corneal hysteresis and corneal resistance factor; endothelial cell density and morphology; central corneal thickness; and wavefront aberrations were measured before and 12 months after the CXL. RESULTS Manifest refraction spherical equivalent and refractive cylinder improved significantly only in conventional group. Uncorrected and corrected distant visual acuity did not change significantly in either group. Also there was no significant change in the maximum and mean keratometry after 12 months. There was significant decrease in central corneal thickness in both groups which was more prominent in conventional group. Endothelial cell density reduced only in the conventional group which was not statistically significant (P = 0.147). CH, CRF, and wavefront aberrations did not change significantly in either group. We did not observe any significant difference in the changes of the variables between the two groups. CONCLUSIONS Accelerated CXL with 9 mW/cm2 irradiation for 10 min had similar refractive, visual, keratometric, and aberrometric results and less adverse effects on the corneal thickness and endothelial cells as compared with the conventional method after 12 months follow-up. However, randomized clinical trials with longer follow-ups and larger sample sizes are needed.
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Standard corneal collagen crosslinking versus transepithelial iontophoresis-assisted corneal crosslinking, 24 months follow-up: randomized control trial.
Bikbova, G, Bikbov, M
Acta ophthalmologica. 2016;(7):e600-e606
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Abstract
PURPOSE To compare the results of standard corneal crosslinking (CXL) and transepithelial iontophoresis-assisted CXL after 24 months follow-up. MATERIAL AND METHODS Corneal crosslinking (CXL) was performed in a series of 149 eyes of 119 patients with keratoconus I-II of Amsler classification. Depending on the CXL method, patients were divided into two groups: (1) 73 eyes with standard CXL and (2) 76 eyes with transepithelial iontophoresis-assisted CXL. Depending on the group, epithelium removal or administration of riboflavin solution by iontophoresis for 10 min was performed, after which standard surface UVA irradiation (370 nm, 3 mW/cm2 ) was performed at a 5-cm distance for 30 min. RESULTS A statistically significant difference in corrected distance visual acuity (CDVA) was observed between the two groups, with a better outcome in the second group after 6 months (p = 0.037); however, no significant difference was found 24 months after treatment (p = 0.829). Stabilization and regression of keratometry values were achieved in both groups, but standard CXL was more effective. The average demarcation line depth in the standard CXL group was 292 ± 14 μm after 14 days and 172 ± 16 μm in the transepithelial iontophoresis-assisted CXL group. No demarcation line was detected after 1 month and 3 months in 45% and 100% of the eyes in the second group respectively. CONCLUSION Transepithelial iontophoresis-assisted collagen crosslinking showed to be less effective than standard CXL after 24 months of follow-up, possibly due to a more superficial formation of corneal collagen crosslinks, however the stopping of disease progression was achieved 24 months after procedure.