Corneal collagen cross-linking for treating keratoconus.
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ABSTRACT:
SUBMITTER: Sykakis E
PROVIDER: S-EPMC10645161 | biostudies-literature | 2015 Mar
REPOSITORIES: biostudies-literature
Publications
Corneal collagen cross-linking for treating keratoconus.
Sykakis Evripidis E Karim Rushmia R Evans Jennifer R JR Bunce Catey C Amissah-Arthur Kwesi N KN Patwary Showrob S McDonnell Peter J PJ Hamada Samer S
The Cochrane database of systematic reviews 20150324 3
<h4>Background</h4>Keratoconus is a condition of the eye that affects approximately 1 in 2000 people. The disease leads to a gradual increase in corneal curvature and decrease in visual acuity with consequent impact on quality of life. Collagen cross-linking (CXL) with ultraviolet A (UVA) light and riboflavin (vitamin B2) is a relatively new treatment that has been reported to slow or halt the progression of the disease in its early stages.<h4>Objectives</h4>The objective of this review was to a ...[more]
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Project description:To evaluate the efficacy of collagen cross-linking (CXL) one year after treatment for keratoconus compared to no treatment by summarizing randomized controlled trials (RCTs) using a systematic review.Trials meeting the selection criteria were quality appraised, and the data were extracted by two independent authors. The outcome parameters included maximum keratometry (Kmax), corneal thickness at the thinnest point, best spectacle-corrected visual acuity (BSCVA), uncorrected visual acuity (UCVA), spherical equivalent (SE) refraction, and cylindrical refraction one year after CXL. We compared the changes in the above parameters with the control group.We identified five RCTs involving 289 eyes that met the eligibility criteria for this systematic review. The changes in BSCVA from baseline to one year exhibited a significant difference between the two groups. There was no statistically significant difference between the two groups for changes in corneal thickness and cylindrical refraction. We did not conduct a meta-analysis in Kmax, UCVA, and SE refraction because their I2 values were greater than 50%.According to the systematic review, CXL may be effective in halting the progression of keratoconus for one year under certain conditions, although evidence is limited due to the significant heterogeneity and paucity of RCTs.
| S-EPMC5485290 | biostudies-other
Project description:PurposeTo investigate patient risk factors and to look for potential causes of sterile infiltrates following an unexpected cluster of sterile keratitis after a routine collagen cross-linking (CXL) list.MethodsThe records of all 148 cases of CXL were reviewed retrospectively. The equipment and solutions used and our clinic's standard operating procedure for CXL were reviewed. An in-vitro experiment to explore the variation in ultraviolet A (UVA) irradiance from fluctuations in the working distance of the UVA lamp was conducted.ResultsThe four patients who developed sterile infiltrates had steeper maximum corneal curvatures (68.0±7.3 D) and thinner pachymetry (389.9±49.0 μm) than the 144 who did not (57.0±8.2 D, P=0.05; 454.6±45.4 μm, P=0.08). A corneal curvature of >60 Dand a pachymetry of <425 μm were significant risk factors. All four affected cases obtained a complete resolution with topical antibiotics and steroids. The unaided VA and the maximum K improved from their pre-operative levels in three out of four patients. A 2-mm reduction in distance of the VEGA C.B.M. X-Linker from a treated surface increased irradiance to 3.5-3.7 mW/cm(2), which is above the threshold for endothelial toxicity.ConclusionPatients with thinner and steeper corneas are at an increased risk of developing sterile keratitis. The visual outcomes despite this complication are good.
| S-EPMC4274277 | biostudies-literature
Project description:IntroductionEpithelium-off cross-linking (epi-off CXL) has long been established as the gold standard treatment for progressive keratoconus. Several protocols for epithelium-on (epi-on) CXL have been proposed to help reduce post-operative pain and facilitate visual recovery, but there is no epi-on treatment approach that is currently approved in the United States. The hydrophilic and macromolecular characteristics of conventional epi-off riboflavin formulations may create clinical challenges for absorption through an intact epithelium. This study investigates the clinical efficacy of a dextran-free hypotonic riboflavin ophthalmic solution (Photrexa, Glaukos, Burlington, MA, USA), approved for epi-off CXL, in a novel epi-on CXL protocol.MethodsTwenty-five eyes of 17 patients were treated in this prospective, single-arm study using a hypotonic riboflavin formulation without dextran and low irradiance UVA (3mW/cm2) for epi-on CXL. Visual acuity, as well as refractive and keratometry outcomes, were observed over 12 months.ResultsAt 12 months, Kmax was stable with no clinically or statistically significant change from a mean pre-op of 55.4D to 55.9D (p=0.13). Uncorrected and best corrected logMAR visual acuity significantly improved from 0.77 to 0.62 and from 0.17 to 0.12, respectively. There were no significant adverse safety events.ConclusionPatients who underwent epi-on CXL with dextran-free hypotonic riboflavin demonstrated improvements in uncorrected and best corrected visual acuity with stable keratometry at 12 months post-operatively. The efficacy is consistent with other epi-on studies to date but remains lower than standard epi-off CXL. New technologies, including supplemental oxygen and transepithelial riboflavin ophthalmic solutions, are currently under clinical evaluation and may offer a path forward for epi-on CXL in the USA.
| S-EPMC8273905 | biostudies-literature
Project description:The Assessment of theranostic guided riboflavin/UV-A corneal cross-linking for treatment of keratoconus (ARGO; registration number NCT05457647) clinical trial tests the hypothesis that theranostic-guided riboflavin/UV-A corneal cross-linking (CXL) can provide predictable clinical efficacy for halting keratoconus progression, regardless of treatment protocol, i.e., either with or without epithelial removal. Theranostics is an emerging therapeutic paradigm of personalized and precision medicine that enables real-time monitoring of image-guided therapy. In this trial, the theranostic software module of a novel UV-A medical device will be validated in order to confirm its accuracy in estimating corneal cross-linking efficacy in real time. During CXL procedure, the theranostic UV-A medical device will provide the operator with an imaging biomarker, i.e., the theranostic score, which is calculated by non-invasive measurement of corneal riboflavin concentration and its UV-A light mediated photo-degradation. ARGO is a randomized multicenter clinical trial in patients aged between 18 and 40 years with progressive keratoconus aiming to validate the theranostic score by assessing the change of the maximum keratometry point value at 1-year postoperatively. A total of 50 participants will be stratified with allocation ratio 1:1 using a computer-generated stratification plan with blocks in two treatment protocols, such as epithelium-off or epithelium-on CXL. Following treatment, participants will be monitored for 12 months. Assessment of safety and performance of theranostic-guided corneal cross-linking treatment modality will be determined objectively by corneal tomography, corneal endothelial microscopy, visual acuity testing and slit-lamp eye examination.
| S-EPMC10313539 | biostudies-literature
Project description:PurposeTo present the case of a patient that underwent corneal crosslinking for progressive keratoconus and 18 months later revealed clinically significant corneal stromal haze.ObservationsA 20-year-old male presented with progressive visual loss OU for the past few years. His corrected distance visual acuity (CDVA) OD was 20/30 (-2.75 -1.75 @55) and OS 20/30 (-0.50 -1.75@110). Corneal topography revealed keratoconus OU and the patient underwent corneal crosslinking according to the Dresden Protocol. The postoperative regimen included combined tobramycin and dexamethasone qid along with lubrication until epithelium healed and then fluorometholone qid with weekly tapering. At 3 months postoperatively, his topography was stable and his corrected distance visual acuity (CDVA) was 20/25 OU. On slit lamp examination, only clinically insignificant stromal haze was observed. At 18 months postoperatively, the patient reported vision deterioration. On examination his CDVA was 20/25 in right eye, and 20/40 in his left eye. Deep stromal haze was revealed in his central cornea, more dense in his left eye. Corneal topography was stable and the CDVA loss was attributed to the notable deep stromal haze. The patient was treated with dexamethasone qid with biweekly tapering. 18 months after corneal crosslinking, the patient demonstrated clinically significant stromal haze, most prominent OS. He was treated with dexamethasone qid. One month later his CDVA OS gradually improved to 20/25, and stromal haze was still noted but less dense.Conclusions and importanceLate-onset deep corneal haze is a possible complication of corneal crosslinking in keratoconic patients.
| S-EPMC6411486 | biostudies-literature
Project description:ObjectiveTo evaluate the efficacy of corneal collagen cross-linking (CXL) for the treatment of keratoconus.MethodsWe performed a literature search for randomized controlled trials that assessed the effect of CXL in slowing progression of keratoconus. The primary outcome measures included changes of topographic parameters, visual acuity, and refraction. Efficacy estimates were evaluated by weighted mean difference (WMD) and 95% confidence interval (CI) for absolute changes of the interested outcomes.ResultsSignificant decrease in mean keratometry value, maximum keratometry value and minimum keratometry value were demonstrated in the CXL group compared with the control group (WMD = -1.65; 95% CI: -2.51 to -0.80; P < 0.00001; WMD = -2.05; 95% CI: -3.10 to -1.00; P < 0.00001; WMD = -1.94; 95% CI: -2.63 to -1.26; P < 0.00001; respectively). Best spectacle-corrected visual acuity improved significantly in CXL group (WMD = -0.10; 95% CI: -0.15 to -0.05; P < 0.00001), whereas uncorrected visual acuity did not differ statistically. Manifest cylinder error decreased significantly in patients undergoing CXL procedure compared with control patients in sensitivity analysis (WMD = -0.388; 95% CI: -0.757 to -0. 019; P = 0.04). The changes in central corneal thickness and intraocular pressure were not statistically significant.ConclusionCXL may be an effective option in stabilizing keratoconus. Further long-term follow-up studies will be necessary to assess the persistence of CXL.
| S-EPMC4436191 | biostudies-literature
Project description:Previous studies investigating the effectiveness of conventional corneal collagen cross-linking (CXL) and transepithelial CXL in keratoconus treatment have reported conflicting outcomes. Therefore, we conducted a meta-analysis to compare the effectiveness of these treatments. We searched MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials for prospective randomized controlled trials (RCTs) with no restrictions. We included visual acuity (corrected distance visual acuity, uncorrected distance visual acuity) and corneal keratometry (K) as primary outcome parameters, and spherical equivalent, central corneal thickness (CCT), and endothelial cell density, as secondary parameters. We finally included seven reports (including six RCTs involving 305 participants and 344 eyes). Our analysis revealed significant postoperative differences in average K and CCT values between conventional and transepithelial CXL-treated patients [K: weighted mean difference (WMD) = 0.79, 95% confidence interval (CI) = 0.04-1.53, p = 0.04; CCT: WMD = 4.53, 95% CI = 0.42-8.64, p = 0.03]. In contrast, we did not find any significant differences in visual acuity, flattest K value, steepest K value, cylinder K value, apex K value, spherical equivalent, or endothelial cell density between groups. In conclusion, transepithelial CXL has a more protective influence on corneal thickness than conventional CXL, and results in lesser postoperative corneal flattening. Further investigation of the clinical outcomes of transepithelial CXL is required.
| S-EPMC5886478 | biostudies-literature
Project description:PurposeTo comprehensively compare the long-term outcome of the combined topography guided photorefractive keratectomy (TG-PRK) with accelerated corneal cross-linking (ACXL) and ACXL alone in eyes with progressive keratoconus. The analysis focused on the changes in the detailed corneal aberrometric values.MethodsThis single-center, prospective cohort study included 28 patients (30 eyes) of the TG-PRK plus ACXL group and 14 patients (15 eyes) of the ACXL alone group. The mean duration of the follow-up was 44 ± 10.18 months (ranged from 31 to 65 months). The preoperative data and the postoperative measurement data at the last follow-up visit, including demographic data, uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction, corneal topography, pachymetry, aberrometry and densitometry were analyzed.ResultsThe CDVA significantly improved in the TG-PRK plus ACXL group at the last follow-up visit (p = 0.006), while no significant improvement was found in the ACXL alone group (p = 0.432). The maximal keratometry of the anterior corneal surface (Kmax) of both groups significantly decreased at the last follow-up visit (p < 0.05). Compared with the ACXL alone group, the Kmax of the TG-PRK plus ACXL group showed a greater decline (p = 0.008). The total corneal aberrations, the corneal lower-order aberrations (LOAs), the corneal higher order aberrations (HOAs), the vertical coma and the spherical aberration (SA) at the 4.0 mm and 6.0 mm zone of the TG-PRK plus ACXL group significantly decreased at the last follow-up visit (all p < 0.05). The declines of the total corneal aberrations, the corneal LOAs, the corneal HOAs and the vertical coma at the 4.0 mm and 6.0 mm zone of the TG-PRK plus ACXL group were significantly higher than those in the ACXL alone group (p < 0.001).ConclusionCompared with ACXL alone, combined TG-PRK with ACXL procedure had a significantly higher reduction in the corneal HOAs and better CDVA, while providing a similar long-term stability and safety. For progressive keratoconus patients with adequate corneal thickness, the combined procedure might be a recommended treatment option.
| S-EPMC11345261 | biostudies-literature
Project description:PurposeTo describe a case of endothelial damage after photorefractive keratectomy (PRK) combined with corneal cross-linking (CXL).ObservationsA 34-year-old man with diagnosis of stable keratoconus presented at our clinic complaining of vision loss in the left eye after same-day simultaneous PRK and CXL. One year postoperatively, slit-lamp examination showed central corneal haze and specular microscopy demonstrated reduced endothelial cell density compared with the preoperative state. Corrected distance visual acuity decreased from 18/20 preoperatively to 20/60 postoperatively. The thinnest corneal thickness value decreased from 432 μm preoperatively to 328 μm postoperatively.Conclusions and importanceThe present case demonstrates the importance of appropriate determination of treatment parameters for simultaneous PRK and CXL in keratoconus, even if the disease is stable prior to treatment.
| S-EPMC6378891 | biostudies-literature
Project description:PurposeTo report a case of bilateral and repetitive corneal perforations after corneal cross-linking (CXL) for keratoconus in a woman harboring potentially pathogenic variants in the ZNF469 gene and to characterize the keratoconus phenotype in this woman and her daughter who shared the same ZNF469 mutations.MethodsClinical characterization of the proband and her daughter followed by sequencing of the genes associated with brittle cornea syndrome, ZNF469 and PRDM5, in both individuals.ResultsAn Ashkenazi Jewish woman in her sixth decade presented with diffuse corneal thinning and progressive steepening consistent with keratoconus. After CXL, epithelium-off in the first eye and epithelium-on in the second, she developed spontaneous corneal perforations in each eye. Her daughter in her fourth decade demonstrated a similar pattern of diffuse corneal thinning and progressive corneal steepening but did not undergo CXL and did not develop corneal perforation. Screening of the ZNF469 and PRDM5 genes revealed 3 missense ZNF469 variants (c.2035G>A, c.10244G>C, and c.11119A>G) in cis arrangement on 1 allele of ZNF469 in both proband and her daughter. Although the 3 variants share low (<0.01) global minor allele frequencies, each has significantly higher minor allele frequencies (0.01-0.03) in the Ashkenazi Jewish population, leading to uncertainty regarding a pathogenic role for the identified variants.ConclusionsCXL may be associated with the development of corneal perforation in particular at-risk individuals with keratoconus. Identifying clinical and genetic risk factors, including screening of ZNF469 and PRDM5, may be useful in the prevention of significant complications after CXL.
| S-EPMC6612572 | biostudies-literature