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PURPOSE: This clinical investigation compared the performance and safety of Eyestil Plus® (SIFI) and Vismed Multi® (TRB Chemedica) for reducing keratitis lesions in moderate-to-severe dry eye disease (DED) patients. MATERIALS AND METHODS: This was a randomised, double-blind, multicentre investigation. 96 adults (>18 years of age) with moderate-to-severe DED received Eyestil Plus® (N = 48) or Vismed Multi® (n = 48) 6 times daily for 3 months. The primary objective clinical performance after 1 month as global corneal and conjunctival staining scores. The secondary objectives were clinical performance after 3 months, tear film stability (tear break up time (TBUT), tear production (Schirmer test), patient-reported outcomes (PROs), investigator satisfaction, and safety. RESULTS: 96 participants were randomised to receive the clinical investigations' treatments, 82.3% of them were female and their mean age was 65.8 years. The non-inferiority of Eyestil Plus® for moderate-to-severe DED was demonstrated at 1 month. No statistical difference was found for any of the study's objectives: change at 1 and 3 months of the global corneal and conjunctival staining score (p-value = 0.506 and 0.661, respectively), change at 1 and 3 months (p-value = 0.538 and 0.302) for TBUT test; change at 3 months for Schirmer test (p-value = 0.540). There were no changes for PROs either. Investigator satisfaction was high for both products. 16.6% of the participants experienced adverse events. CONCLUSION: This clinical investigation showed the non-inferiority of Eyestil Plus® compared to Vismed Multi® regarding performance and safety in a moderate-to-severe DED population.
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OBJECTIVES: To analyse the state of refractive surgery with Visian ICL phakic lens implantation in Spain, indicating the mean ranges of implanted powers, visual and refractive outcomes obtained and safety and efficacy indices. METHOD: This is a population-based, cross-sectional, descriptive, analytical, retrospective, multicentre study in which each co-author collected data from at least the last 10 patients (up to a maximum of 30) with Visian ICL phakic lens implantation. One eye from each subject was randomly selected for study inclusion, and the variables analysed were: age, gender, visual acuities with and without correction pre and post-surgery, preoperative and residualrefraction, keratometry, endothelial cellular density, anterior chamber depth from endothelium, central corneal pachymetry, intraocular pressure, white-white, implanted lens (power and size), expected and achieved spherical equivalent (SEQ) post-surgery at one month after surgery. RESULTS: A sample of 140 eyes was obtained from 140 patients with a mean age of 31.35 ± 7.28 years. Mean preoperative SEQ was -6.33 ± 3.69D, mean CDVA was 0.96 ± 0.16, ACD was 3.30 ± 0.29 mm, WTW 12.02 ± 0.40 mm, CCT 535.03 ± 37.68 µm, ECD 2684.37 ± 313.74 cels/mm2 and IOP 14.84 ± 2.59 mmHg. 66.4% of the implanted lenses were spherical ICLs and 33.6% toric, with a mean power of -7.81 ± 4.09D and a mean cylinder of 2.27 ± 1.23D. 5.7% of the implanted lenses were hypermetropic. The mean SEQ target selected was +0.04 ± 0.27D. 48.92% of the implanted lenses were of size 13.2 mm, with the remaining 36.69, 10.79 and 3.60% being of sizes 12.6, 12.1 and 13.7 mm, respectively. At one month after surgery a residual SEQ of -0.01 ± 0.31D was obtained. The efficacy and safety indices were 1.06 ± 0.18 and 1.10 ± 0.19, respectively. The mean central vault was 508.80 ± 201.04 µm. The accuracy between the calculated SEQ and the obtained SEQ was 99.3% for spherical lenses and 88.2% for Cyl correction. The mean ECD at 1 month after surgery was 2805.53±273.30céls/mm2, which was a difference from preoperative of 0.11% (p = 0.922), similarly, the mean IOP was 13.98 ± 2.57 mmHg, which was a difference of -0.92 ± 2.80 mmHg. CONCLUSIONS: ICL phakic lens surgery is an effective, safe and predictable procedure. There were no significant changes in endothelial cell count or intraocular pressure measurement one month after surgery.
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Miopia , Lentes Intraoculares Fácicas , Humanos , Adulto Jovem , Adulto , Estudos Retrospectivos , Espanha , Estudos Transversais , Miopia/cirurgia , Implante de Lente IntraocularRESUMO
In this case-report we describe the first reported case of early-onset fungal interface keratitis (IK) after Descemet Membrane Endothelial Keratoplasty (DMEK) successfully treated with penetrating keratoplasty (PK) during the active stage of infection. A patient with graft failure after Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) was operated on with DMEK. Donor rim culture and broth were positive for Candida albicans. Several interface infiltrates were confirmed and localized using anterior segment optical coherence tomography. Three days after diagnosis, observing clear signs of intraocular infection, the graft was removed with simultaneous washed-up of anterior chamber with fluconazole 1% followed by a PK and intrastromal corneal injections of fluconazole. A best-corrected visual acuity of 20/20 was achieved. This case highlights the importance of analysing every donor rim and broth, despite the patient doesn't show any symptoms or signs during the post-operative period. PK is a viable treatment option in early-onset interface keratitis.
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Doenças da Córnea , Distrofias Hereditárias da Córnea , Epitélio Corneano , Limbo da Córnea , Humanos , Distrofias Hereditárias da Córnea/diagnóstico , Distrofias Hereditárias da Córnea/cirurgia , Doenças da Córnea/diagnóstico , Doenças da Córnea/cirurgia , Limbo da Córnea/cirurgia , Transplante AutólogoRESUMO
OBJECTIVES: To evaluate the effectiveness of deep anterior lamellar keratoplasty (DALK) using Melles technique (technique B) in patients with advanced keratoconus versus a classic technique, penetrating keratoplasty (technique A). METHODOLOGY: Retrospective descriptive comparative study between technique A and technique B in homogeneous groups. RESULTS: Best corrected visual acuity (Snellen test decimal scale) was 0.77±0.32 for group A and 0.62±0.29 for group B, with no statistically significant differences. The mean spherical final refraction in group A was 1.73±5.1 diopters, and the mean spherical equivalent was -3.92±5.1. Technique B group gave values -2.67±4.02 diopters and -4.55±4.08 diopters, respectively, with no statistically significant differences. The residual cylinder after removal of the sutures was 4.47±2.47 diopters for group A and 3.77±1.63 for group B, with no statistically significant differences. CONCLUSION: No statistically significant differences were found for any of the studied variables when comparing both groups using the t -test for independent samples. More studies on the homogeneity and residual stromal bed thickness could provide the key to determine whether this technique is closer to the visual acuity of penetrating keratoplasty or DALK by a descemet technique.