To assess the one-year effectiveness and safety of ranibizumab 0.5 mg in treatment-naïve patients with diabetic macular edema (DME) enrolled in the real-world LUMINOUS study. Patients and methods A 5-year, prospective, observational, open-label, global study which recruited 30,138 patients across all approved indications. Consenting patients (�18 years) who were treatment-naïve or previously treated with ranibizumab or other ocular treatments were treated as per the local ranibizumab label. Here, we present the change in visual acuity (VA) (Early Treatment Diabetic Retinopathy Study letter score; primary treated eye) at Year 1, as well as the change in VA based on injection frequencies (�4 and �5), treatment exposure, and the overall adverse events (AEs) and serious AEs (SAEs) in treatment-naïve DME patients. Results Of the 4,710 DME patients enrolled in the study, 1,063 were treatment-naïve. At baseline, mean age was 64.5 years, 54.7% were male, and 69.2% were white. At 1 year, mean VA letter score improved by +3.5 (n = 502) from a baseline of 57.7 with a mean of 4.5 injections.
This study was conducted on 34 children with chronic renal failure: 27 on regular haemodialysis and seven on conservative treatment. Twenty normal healthy children served as controls. They were subjected to clinical examination including otoscopic examination, basic audiological assessment and transient otoacoustic emission testing (TOAE). Four patients had a conductive hearing loss and five had a bilateral moderately severe high frequency sensory neural hearing loss. TOAE testing was carried out for the rest whose ears displayed normal hearing. No response (fail) was obtained in 8% of them but in none of the controls and a partial pass response in 38% versus 10% of controls (P < 0.001). Cochlear dysfunction was significant only at low frequency levels. The mean overall echo-level and reproducibility were significantly lower in patients than in controls. The same holds true for the subgroup of patients on haemodialysis but not for those on conservative treatment. The overall echo-levels did not correlate with serum urea, creatinine, sodium or potassium.
Purpose. To evaluate the effect of glycemic control on response to therapy of diabetic clinically significant macular edema (CSME). Methods. Patients with CSME had their glycosylated hemoglobin (HbA1c) measured at baseline and 6 months. Central foveal thickness (CFT) and best-corrected visual acuity (BCVA) in logMAR were measured at baseline, 3 months, and 6 months. Therapy included laser and intravitreal bevacizumab. HbA1c was graded as G1 <7%, G23 7%-7.9%, G3 8%-8.9%, G4 >9%. Results. Fifty-two eyes were included with mean logMAR BCVA and CFT as follows: baseline 0.75 and 423±106 µm; 3 months 0.47 and 293±69 µm; and 6 months 0.48 and 324±76 µm. Mean HbA1c was 8.13% and 7.43% at baseline and 6 months, respectively. There was no statistically significant difference between baseline and 6 months HbA1c groups and logMAR BCVAs and CFTs at baseline, 3 months, and 6 months. However, there were positive correlations between baseline HbA1c levels and each of baseline logMAR BCVA (p=0.024), baseline CFT (p<0.001), and 6-month logMAR BCVA (p=0.007). Improved HbA1c by 6 months did not show any correlation with logMAR BCVA and CFT at 6 months. Conclusions. Lower HbA1c appeared to be correlated with better visual acuity and lower CFT values at baseline, and also correlated with significantly better vision and nonsignificantly thinner CFT with therapy at 6 months.
PurposeTo study the subconjunctival silicone oil (SCSO) parameters associated with dellen formation following microincision vitrectomy (MIV).Patients and methodsThis was a case–control study of 20 eyes with SCSO following MIV. Ten of them suffered postoperative dellen formation. Dellen occurrence, their sizes, number of loci, and distance between SCSO and the limbus were recorded. The outcome after silicone-oil removal was evaluated.ResultsThe SCSO was at 3.1±1.2 mm from the limbus. All cases with dellen had SCSO within 2 mm of the limbus (P<0.001). No other factors were found to be associated with dellen formation (age, P=0.414; sex, P=0.656; laterality, P=1; indication for pars plana vitrectomy, P=0.655; instrument gauge, P=0.211; circumference involved by SCSO, P=0.252). All the dellen healed after surgical evacuation of SCSO (P<0.001), leaving scars.ConclusionDellen can be associated with MIV secondary to SCSO near the limbus. Resolution with scarring occurred following SCSO evacuation. Therefore, SCSO should be evacuated as early as possible to avoid long-term peripheral corneal morbidity.
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