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Cross-Linking Assisted Infection Reduction (CLAIR): A Randomized Clinical Trial Evaluating the Effect of Adjuvant Cross-Linking on Bacterial Keratitis.
Prajna, NV, Radhakrishnan, N, Lalitha, P, Rajaraman, R, Narayana, S, Austin, AF, Liu, Z, Keenan, JD, Porco, TC, Lietman, TM, et al
Cornea. 2021;(7):837-841
Abstract
PURPOSE To determine whether there is a benefit to adjuvant corneal cross-linking (CXL) for bacterial keratitis. METHODS This is an outcome-masked, randomized controlled clinical trial. Consecutive patients presenting with a smear-positive bacterial ulcer at Aravind Eye Hospitals at Madurai, Pondicherry, and Coimbatore in India were enrolled. Study eyes were randomized to topical moxifloxacin 0.5% or topical moxifloxacin 0.5% plus CXL. The primary outcome of the trial was microbiological cure at 24 hours on repeat culture. Secondary outcomes included best spectacle corrected visual acuity at 3 weeks and 3 months, percentage of study participants with epithelial healing at 3 weeks and 3 months, infiltrate and/or scar size at 3 weeks and 3 months, 3-day smear and culture, and adverse events. RESULTS Those randomized to CXL had 0.60 decreased odds of culture positivity at 24 hours (95% confidence interval [CI]: 0.10-3.50; P = 0.65), 0.9 logarithm of the minimum angle of resolution lines worse visual acuity (95% CI: -2.8 to 4.6; P = 0.63), and 0.41-mm larger scar size (95% CI: -0.48 to 1.30; P = 0.38) at 3 months. We note fewer corneal perforations or need for therapeutic penetrating keratoplasty in the CXL group. CONCLUSIONS We were unable to confirm a benefit to adjuvant CXL in the primary treatment of moderate bacterial keratitis. However, CXL may reduce culture positivity and complication rates; therefore, a larger trial to fully evaluate this is warranted. TRIAL REGISTRATION NCT02570321.
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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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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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Efficacy of eyedrops containing cross-linked hyaluronic acid and coenzyme Q10 in treating patients with mild to moderate dry eye.
Postorino, EI, Rania, L, Aragona, E, Mannucci, C, Alibrandi, A, Calapai, G, Puzzolo, D, Aragona, P
European journal of ophthalmology. 2018;(1):25-31
Abstract
PURPOSE Dry eye disease (DED) is a common condition causing substantial burden. A randomized, controlled, single-masked study was performed in 40 patients with mild to moderate DED to evaluate the efficacy and safety of a collyrium based on crosslinked hyaluronic acid (XLHA) with coenzyme Q10 (CoQ10). METHODS Enrolled subjects were divided into 2 groups: group A, treated with XLHA + CoQ10; and group B, treated with hyaluronic acid (HA). Eyedrops were administered 4 times daily for 3 months. The Ocular Surface Disease Index (OSDI) questionnaire, tear break-up time (TBUT), corneal and conjunctival staining, and meibomian gland assessment (MGD) were evaluated; furthermore, corneal aesthesiometry, in vivo corneal confocal microscopy, visual acuity, intraocular pressure (IOP), and fundus examination were performed. RESULTS At the end of treatment, OSDI score significantly decreased in groups A and B (p<0.01 and p<0.05, respectively); the decrease was significantly higher in group A. Corneal staining decreased in both groups, with lower scores in group A. The MGD was significantly ameliorated in group A patients. No differences were found for corneal aesthesiometry or TBUT. Epithelial cell reflectivity was significantly reduced only in group A. For keratocytes and stromal matrix parameters, there was a significant improvement in group A. No changes were found for visual acuity, IOP, or fundus examination. CONCLUSIONS The XLHA + CoQ10 treatment showed greater effectiveness in DED compared to HA alone, probably due to the longer permanency on ocular surface and the antioxidant activity of CoQ10. Therefore, XLHA + CoQ10 eyedrops could represent a new possibility in dry eye treatment.
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Comparison of the Conventional Dresden Protocol and Accelerated Protocol With Higher Ultraviolet Intensity in Corneal Collagen Cross-Linking for Keratoconus.
Choi, M, Kim, J, Kim, EK, Seo, KY, Kim, TI
Cornea. 2017;(5):523-529
Abstract
PURPOSE To compare the accelerated corneal cross-linking (CXL) protocol and the conventional Dresden protocol in patients with keratoconus in terms of visual acuity, keratometric values, and topographic parameters. METHODS Twenty-eight eyes of 25 patients with primary keratoconus were divided into 2 groups; 15 eyes in group 1 received CXL under the standard Dresden protocol (3 mW/cm for 30 min, dose 5.4 J/cm) and 13 eyes in group 2 were treated with the accelerated protocol (30 mW/cm for 3 min 40 s, dose 6.6 J/cm). Visual acuity, refractive error, keratometry values obtained by both Pentacam and Auto Kerato-Refractometer, corneal thickness, and topometric indexes were compared 6 months postoperatively. RESULTS The visual acuity improved significantly from 0.17 ± 0.16 to 0.08 ± 0.09 logarithm of the minimum angle of resolution in group 1 (P = 0.009). The cylindrical refractive error improved in both groups (P = 0.05 in group 1 and P = 0.011 in group 2), and the spherical equivalent increased in group 1 (P = 0.021). In group 1, the maximum keratometry value decreased by 0.55 ± 0.89 diopters (P = 0.03), and the mean keratometry value decreased by 0.44 ± 0.63 diopters (P = 0.017), whereas the changes in visual acuity, spherical and spherical equivalent refractive errors, and keratometric values in group 2 were not statistically significant. The corneal thickness at the apex decreased significantly in group 1 (P = 0.001), but the change was not significant in group 2. CONCLUSIONS Despite a higher UV dose (6.6 J/cm), accelerated CXL with higher UV intensity and reduced irradiation time showed a smaller topographic flattening effect than did the conventional Dresden protocol in primary keratoconus with documented progression.
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Corneal Collagen Cross-Linking in the Treatment of Progressive Keratoconus: A Randomized Controlled Contralateral Eye Study.
Seyedian, MA, Aliakbari, S, Miraftab, M, Hashemi, H, Asgari, S, Khabazkhoob, M
Middle East African journal of ophthalmology. 2015;(3):340-5
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BACKGROUND To assess the short-term efficacy and safety of corneal collagen cross-linking (CXL) in preventing the progression of keratoconus (KCN). MATERIALS AND METHODS This randomized controlled clinical trial enrolled 26 patients diagnosed with bilateral progressive KCN and were eligible for CXL. In each patient, one eye was randomly selected for treatment, and the contralateral eye served as the control. The patients underwent CXL with riboflavin drops and ultraviolet radiation in the treated eye. One year follow-up data are presented. Postoperatively, patients were assessed for progression of KCN, visual changes, and other findings. The main outcome measures were maximum simulated keratometry (K-max), best spectacle-corrected visual acuity (BSCVA), and average simulated keratometry. P <0.05 was considered as statistically significant. RESULTS In the treated eyes, the mean K-max values decreased by 0.22 D at 1-year postoperatively and increased by 0.41 D in the control group. This difference was statistically significant (P < 0.001). BSCVA improved slightly (a decrease of 0.13 LogMAR) and decreased slightly in the control group (a 0.01 LogMAR increase). The difference between groups was statistically significant (P = 0.014). There was no decrease in visual acuity attributable to complications of CXL in the treated eyes. At 1-year, the keratometry in 3 (12%) treated eyes increased by more than 0.50 D and were considered cases of failed treatment. CONCLUSION Preliminary and 1-year results indicate CXL can halt the progression of KCN in most cases without causing serious complications.
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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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Evaluation of corneal changes after conventional versus accelerated corneal cross-linking: a randomized controlled trial.
Hashemian, H, Jabbarvand, M, Khodaparast, M, Ameli, K
Journal of refractive surgery (Thorofare, N.J. : 1995). 2014;(12):837-42
Abstract
PURPOSE To evaluate the outcome of accelerated and conventional corneal cross-linking (CXL) procedures regarding their effect on morphological and optical properties of the cornea. METHODS One hundred fifty-three eyes of 153 patients were evaluated before and during a 15-month follow-up period after CXL (76 eyes in the conventional group and 77 eyes in the accelerated group). Measured variables include corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA), refraction, maximum keratometry, endothelial cell density, anterior and posterior stromal keratocyte density, and subbasal nerve density. All variables were compared between the two study groups. RESULTS Cylindrical and spherical components of refraction improved significantly during 15 months of follow-up. No difference was observed between the two study groups. UDVA and CDVA improved in the same manner, with no intergroup differences. Endothelial cell density did not change significantly during the follow-up period in either group. K-max increased slightly in the first month of the follow-up, but started to decrease at postoperative visits without any significant difference in the two groups. Anterior stromal keratocyte density and subbasal nerve density decreased significantly in both groups 1 month postoperatively. Both variables had a more significant decrease in the conventional group at all visits before the 1-year visit. At the final 15-month visit, there were no significant differences in any value between the two groups. CONCLUSIONS Accelerated and conventional CXL seem to have a comparable and acceptable effect on keratoconus in the short-term follow-up period.
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A randomized, controlled trial of corneal collagen cross-linking in progressive keratoconus: three-year results.
Wittig-Silva, C, Chan, E, Islam, FM, Wu, T, Whiting, M, Snibson, GR
Ophthalmology. 2014;(4):812-21
Abstract
PURPOSE To report the refractive, topographic, and clinical outcomes 3 years after corneal collagen cross-linking (CXL) in eyes with progressive keratoconus. DESIGN Prospective, randomized controlled trial. PARTICIPANTS One hundred eyes with progressive keratoconus were randomized into the CXL treatment or control groups. METHODS Cross-linking was performed by instilling riboflavin 0.1% solution containing 20% dextran for 15 minutes before and during the 30 minutes of ultraviolet A irradiation (3 mW/cm(2)). Follow-up examinations were arranged at 3, 6, 12, 24, and 36 months. MAIN OUTCOME MEASURES The primary outcome measure was the maximum simulated keratometry value (Kmax). Other outcome measures were uncorrected visual acuity (UCVA; measured in logarithm of the minimum angle of resolution [logMAR] units), best spectacle-corrected visual acuity (BSCVA; measured in logMAR units), sphere and cylinder on subjective refraction, spherical equivalent, minimum simulated keratometry value, corneal thickness at the thinnest point, endothelial cell density, and intraocular pressure. RESULTS The results from 48 control and 46 treated eyes are reported. In control eyes, Kmax increased by a mean of 1.20±0.28 diopters (D), 1.70±0.36 D, and 1.75±0.38 D at 12, 24, and 36 months, respectively (all P <0.001). In treated eyes, Kmax flattened by -0.72±0.15 D, -0.96±0.16 D, and -1.03±0.19 D at 12, 24, and 36 months, respectively (all P <0.001). The mean change in UCVA in the control group was +0.10±0.04 logMAR (P = 0.034) at 36 months. In the treatment group, both UCVA (-0.15±0.06 logMAR; P = 0.009) and BSCVA (-0.09±0.03 logMAR; P = 0.006) improved at 36 months. There was a significant reduction in corneal thickness measured using computerized videokeratography in both groups at 36 months (control group: -17.01±3.63 μm, P <0.001; treatment group: -19.52±5.06 μm, P <0.001) that was not observed in the treatment group using the manual pachymeter (treatment group: +5.86±4.30 μm, P = 0.181). The manifest cylinder increased by 1.17±0.49 D (P = 0.020) in the control group at 36 months. There were 2 eyes with minor complications that did not affect the final visual acuity. CONCLUSIONS At 36 months, there was a sustained improvement in Kmax, UCVA, and BSCVA after CXL, whereas eyes in the control group demonstrated further progression.
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Initial results from mechanical compression of the cornea during crosslinking for keratoconus.
Beckman Rehnman, J, Behndig, A, Hallberg, P, Lindén, C
Acta ophthalmologica. 2014;(7):644-9
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PURPOSE To compare refractive changes after corneal crosslinking with and without mechanical compression of the cornea. METHODS In a prospective, open, randomized case-control study conducted at the Department of Ophthalmology, Umeå University Hospital, Sweden, sixty eyes of 43 patients with progressive keratoconus aged 18-28 years planned for corneal crosslinking and corresponding age- and sex-matched control subjects were included. The patients were randomized to conventional corneal crosslinking (CXL; n = 30) or corneal crosslinking with mechanical compression using a flat rigid contact lens sutured to the cornea during treatment (CRXL; n = 30). Subjective refraction and ETDRS best spectacle-corrected visual acuity (BSCVA), axial length measurement, keratometry and pachymetry were performed before and 1 and 6 months after treatment. RESULTS The keratoconus patients had poorer BSCVA, higher refractive astigmatism and higher keratometry readings than the control subjects at baseline (p < 0.01). In the CXL group, BSCVA increased from 0.19 ± 0.26 to 0.14 ± 0.18 logMar (p = 0.03), and the spherical equivalent improved from -1.9 ± 2.8 D to -1.4 ± 2.4 D (p = 0.03). Maximum keratometry readings decreased after CXL from 53.1 ± 4.9 D to 52.6 ± 5.2 D (p = 0.02), and the axial length decreased in the CXL group, likely due to post-treatment corneal thinning (p = 0.03). In the CRXL group, all the above variables were unaltered (p > 0.05). CONCLUSION At 6 months, the refractive results from CRXL did not surpass those of conventional CXL treatment. Rather, some variables indicated a slightly inferior effect. Possibly, stronger crosslinking would be necessary to stabilize the cornea in the flattened configuration achieved by the rigid contact lens.