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Three Year RSA Evaluation of Vitamin E Diffused Highly Cross-linked Polyethylene Liners and Cup Stability.
Sillesen, NH, Greene, ME, Nebergall, AK, Nielsen, PT, Laursen, MB, Troelsen, A, Malchau, H
The Journal of arthroplasty. 2015;(7):1260-4
Abstract
Vitamin E diffusion into highly cross-linked polyethylene (E-XLPE) is a method for enhancing oxidative stability of acetabular liners. The purpose of this study was to evaluate in vivo penetration of E-XLPE using radiostereometric analysis (RSA). Eighty-four hips were recruited into a prospective 10-year RSA. This is the first evaluation of the multicenter cohort after 3-years. All patients received E-XLPE liners (E1, Biomet) and porous-titanium coated cups (Regenerex, Biomet). There was no difference (P=0.450) in median femoral head penetration into the E-XLPE liners at 3-years comparing cobalt-chrome heads (-0.028mm; inter-quartile range (IQR) - 0.065 to 0.047) with ceramic heads (-0.043mm, IQR - 0.143to0.042). The 3-year follow-up indicates minimal E-XLPE liner penetration regardless of head material and minimal early cup movement.
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Collagen cross-linking with photoactivated riboflavin (PACK-CXL) for the treatment of advanced infectious keratitis with corneal melting.
Said, DG, Elalfy, MS, Gatzioufas, Z, El-Zakzouk, ES, Hassan, MA, Saif, MY, Zaki, AA, Dua, HS, Hafezi, F
Ophthalmology. 2014;(7):1377-82
Abstract
PURPOSE To investigate the efficacy and safety of corneal collagen cross-linking (CXL) with photoactivated riboflavin (photoactivated chromophore for infectious keratitis [PACK]-CXL) in the management of infectious keratitis with corneal melting. DESIGN Prospective clinical trial. PARTICIPANTS Forty eyes from 40 patients with advanced infectious keratitis and coexisting corneal melting. METHODS Twenty-one patients (21 eyes) underwent PACK-CXL treatment in addition to antimicrobial therapy. The control group consisted of 19 patients (19 eyes) who received only antimicrobial therapy. MAIN OUTCOME MEASURES The slit-lamp characteristics of the corneal ulceration, corrected distance visual acuity, duration until healing, and complications were documented in each group. The Mann-Whitney U test was used for statistical analysis. P values less than 0.05 were considered statistically significant. RESULTS The average time until healing was 39.76 ± 18.22 days in the PACK-CXL group and 46.05 ± 27.44 days in the control group (P = 0.68). After treatment and healing, corrected distance visual acuity was 1.64 ± 0.62 in the PACK-CXL group and 1.67 ± 0.48 in the control group (P = 0.68). The corneal ulceration's width and length was significantly bigger in the PACK-CXL group (P = 0.004 and P = 0.007). Three patients in the control group demonstrated corneal perforation; infection recurred in 1 of them. No serious complications occurred in the PACK-CXL group. CONCLUSIONS Corneal CXL with photoactivated riboflavin did not shorten the time to corneal healing; however, the complication rate was 21% in the control group, whereas there was no incidence of corneal perforation or recurrence of the infection in the PACK-CXL group. These results indicate that PACK-CXL may be an effective adjuvant therapy in the management of severe infectious keratitis associated with corneal melting.
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Characteristics influencing outcomes of corneal collagen crosslinking for keratoconus and ectasia: implications for patient selection.
Greenstein, SA, Hersh, PS
Journal of cataract and refractive surgery. 2013;(8):1133-40
Abstract
PURPOSE To determine preoperative patient characteristics that may predict topography and visual acuity outcomes of corneal collagen crosslinking (CXL). SETTING Cornea and refractive surgery practice. DESIGN Cohort study. METHODS Crosslinking was performed in eyes with keratoconus or corneal ectasia. Multiple regression and odds ratio analyses were performed to determine independent predictors of changes in topography-derived maximum keratometry (K) and corrected distance visual acuity (CDVA) 1 year postoperatively. Preoperative characteristics included sex, age, uncorrected distance visual acuity (UDVA), CDVA, maximum keratometry (K), corneal thickness, corneal haze, disease group, and cone location. Postoperative improvement in maximum K was defined as flattening of 2.0 diopters (D) or more and worsening as steepening of 1.0 D or more. Improvement in CDVA was defined as a gain of 2 lines or more and worsening as a loss of 1 line or more. RESULTS The study comprised 104 eyes (66 keratoconus; 38 corneal ectasia). Eyes with a preoperative CDVA of 20/40 or worse were 5.9 times (95% confidence interval [CI], 2.2-6.4) more likely to improve 2 Snellen lines or more. Eyes with a maximum K of 55.0 D or more were 5.4 times (95% CI, 2.1-14.0) more likely to have topographic flattening of 2.0 D or more. No preoperative characteristics significantly predicted worsening of visual acuity or corneal topography. CONCLUSIONS Patients with worse preoperative CDVA and higher K values, particularly with a CDVA of 20/40 or worse or a maximum K of 55.0 D or more, were most likely to have improvement after CXL. No preoperative characteristics were predictive of CXL failure.
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Patient subjective visual function after corneal collagen crosslinking for keratoconus and corneal ectasia.
Brooks, NO, Greenstein, S, Fry, K, Hersh, PS
Journal of cataract and refractive surgery. 2012;(4):615-9
Abstract
PURPOSE To assess subjective visual function after corneal collagen crosslinking (CXL). SETTING Cornea and refractive surgery subspecialty practice. DESIGN Prospective randomized controlled clinical trial. METHODS Patients completed a subjective questionnaire regarding visual symptoms administered preoperatively and 1 year after CXL. Patients ranked self-reported symptoms of photophobia, difficulty night driving, difficulty reading, diplopia, fluctuations in vision, glare, halo, starburst, dryness, pain, and foreign-body sensation on a scale from 1 to 5. Possible associations of symptoms with changes in corrected distance visual acuity (CDVA) and maximum keratometry were also analyzed. RESULTS One hundred seven eyes of 76 patients had CXL for keratoconus (n = 71) or ectasia (n = 36). The mean preoperative to 1-year postoperative changes in night driving (3.2 ± 1.5 [SD] to 2.8 ± 1.5), difficulty reading (3.1 ± 1.5 to 2.9 ± 1.3), diplopia (2.5 ± 1.3 to 2.1 ± 1.2), glare (3.1 ± 1.4 to 2.7 ± 1.2), halo (2.9 ± 1.4 to 2.5 ± 1.3), starbursts (2.6 ± 1.5 to 2.4 ± 1.4), and foreign-body sensation (1.8 ± 1.1 to 1.6 ± 0.9) were statistically significant. There were no associations between the change in any symptom and changes in CDVA. There was a weak association between the change in night driving, pain, and foreign-body sensations and the change in maximum keratometry. CONCLUSIONS After CXL, patients noted subjective improvement in visual symptoms, specifically night driving, difficulty reading, diplopia, glare, halo, starbursts, and foreign-body sensation. These subjective outcomes corroborate quantitative clinical improvements seen after CXL.
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Corneal thickness changes after corneal collagen crosslinking for keratoconus and corneal ectasia: one-year results.
Greenstein, SA, Shah, VP, Fry, KL, Hersh, PS
Journal of cataract and refractive surgery. 2011;(4):691-700
Abstract
PURPOSE To determine the changes in corneal thickness over time after corneal collagen crosslinking (CXL) for keratoconus and corneal ectasia. SETTING Cornea and refractive surgery subspecialty practice. DESIGN Prospective randomized controlled clinical trial. METHODS Corneal thickness at the apex, thinnest point, and pupil center were measured using Scheimpflug imaging (Pentacam) at baseline and 1, 3, 6, and 12 months after CXL. The treatment group was compared with both a sham-procedure control group and a fellow-eye control group. Associations with clinical outcomes (uncorrected and corrected distance visual acuities and maximum keratometry) were analyzed. RESULTS The study comprised 82 eyes, 54 with keratoconus and 28 with ectasia after laser in situ keratomileusis. The mean preoperative thinnest pachymetry was 440.7 μm ± 52.9 (SD). After CXL, the cornea thinned at 1 month (mean change -23.8 ± 28.7 μm; P<.001) and from 1 to 3 months (mean change -7.2 ± 20.1 μm, P=.002), followed by a recovery of the corneal thickness between 3 months and 6 months (mean +20.5 ± 20.4 μm; P<.001). At 1 year, apex and pupil-center thicknesses returned to baseline (P=.11 and P=.06, respectively); however, the thinnest pachymetry remained slightly decreased from baseline to 12 months (mean change -6.6 ± 22.4 μm; P=.01). The recovery of corneal thickness was more rapid in ectasia than in keratoconus. There was no association between the degree of corneal thinning at 3 months and clinical outcomes after CXL. CONCLUSIONS After CXL, the cornea thins and then recovers toward baseline thickness. The cause and implications of corneal thickness changes after CXL remain to be elucidated. FINANCIAL DISCLOSURE No author has a financial or proprietary interest in any material or method mentioned. Additional disclosure is found in the footnotes.
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Natural history of corneal haze after collagen crosslinking for keratoconus and corneal ectasia: Scheimpflug and biomicroscopic analysis.
Greenstein, SA, Fry, KL, Bhatt, J, Hersh, PS
Journal of cataract and refractive surgery. 2010;(12):2105-14
Abstract
PURPOSE To determine the natural history of collagen crosslinking (CXL)-associated corneal haze measured by Scheimpflug imagery and slitlamp biomicroscopy in patients with keratoconus or ectasia after laser in situ keratomileusis. SETTING Cornea and refractive surgery subpecialty practice, United States. DESIGN Prospective randomized controlled clinical trial. METHODS The treatment group received ultraviolet-A/riboflavin CXL therapy. The control group received riboflavin alone without epithelial debridement. To objectively measure CXL-associated corneal haze, corneal densitometry using Scheimpflug imagery was measured and the changes in haze were analyzed over time. A similar analysis was performed using clinician-determined slitlamp haze. Correlation of CXL-associated corneal haze with postoperative outcomes was analyzed. RESULTS The mean preoperative corneal densitometry was 14.9 ± 1.93 (SD) (Pentacam Scheimpflug densitometry units). Densitometry peaked at 1 month (mean 23.4 ± 4.40; P<.001), with little change at 3 months (mean 22.4 ± 4.79; P = .06) and decreased between 3 months and 6 months (19.4 ± 4.48; P<.001) and between 6 months and 12 months. By 12 months, densitometry had not completely returned to baseline in the entire cohort (mean 17.0 ± 3.82; P<.001) and the keratoconus subgroup; however, it returned to baseline in the ectasia group (16.1 ± 2.41; P = .15). The postoperative course of slitlamp haze was similar to objective densitometry measurements. Increased haze, measured by densitometry, did not correlate with postoperative clinical outcomes. CONCLUSIONS The time course of corneal haze after CXL was objectively quantified; it was greatest at 1 month, plateaued at 3 months, and was significantly decreased between 3 months and 12 months. Changes in haze did not correlate with postoperative clinical outcomes.