for the Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity (CARE-ROP) Study Group IMPORTANCE Anti-vascular endothelial growth factor (VEGF) therapies are a novel treatment option in retinopathy of prematurity (ROP). Data on dosing, efficacy, and safety are insufficient.OBJECTIVE To investigate lower doses of anti-VEGF therapy with ranibizumab, a substance with a significantly shorter systemic half-life than the standard treatment, bevacizumab.DESIGN, SETTING, AND PARTICIPANTS This randomized, multicenter, double-blind, investigator-initiated trial at 9 academic medical centers in Germany compared ranibizumab doses of 0.12 mg vs 0.20 mg in infants with bilateral aggressive posterior ROP; ROP stage 1 with plus disease, 2 with plus disease, or 3 with or without plus disease in zone I; or ROP stage 3 with plus disease in posterior zone II. Patients were recruited between September 2014 and August 2016. Twenty infants were screened and 19 were randomized.INTERVENTIONS All infants received 1 baseline ranibizumab injection per eye. Reinjections were allowed in case of ROP recurrence after at least 28 days. MAIN OUTCOMES AND MEASURESThe primary end point was the number of infants who did not require rescue therapy at 24 weeks. Key secondary end points included time-to-event analyses, progression of physiologic vascularization, and plasma VEGF levels. Stages of ROP were photodocumented and reviewed by an expert committee.RESULTS Nineteen infants with ROP were enrolled (9 [47.4%] female; median [range] postmenstrual age at first treatment, 36.4 [34.7-39.7] weeks), 3 of whom died during the study (1 in the 0.12-mg group and 2 in the 0.20-mg group). Of the surviving infants, 8 (88.9%) (17 eyes [94.4%]) in the 0.12-mg group and 6 (85.7%) (13 eyes [92.9%]) in the 0.20-mg group did not require rescue therapy. Both ranibizumab doses were equally successful in controlling acute ROP (Cochran-Mantel-Haenszel analysis; odds ratio, 1.88; 95% CI, 0.26-13.49; P = .53). Physiologic intraretinal vascularization was superior in the 0.12-mg group. The VEGF plasma levels were not systematically altered in either group.CONCLUSIONS AND RELEVANCE This pilot study demonstrates that ranibizumab is effective in controlling acute ROP and that 24% of the standard adult dose (0.12 mg) appears equally effective as 40% (0.20 mg). Superior vascularization of the peripheral retina with 0.12 mg of ranibizumab indicates that the lower dose may be favorable. Unchanged plasma VEGF levels point toward a limited systemic drug exposure after ranibizumab.
Aims-To report the occurrence of paracentral scotomata after pars plana vitrectomy for idiopathic macular holes. Methods-In 15 patients static microperimetry using a Rodenstock scanning laser ophthalmoscope (SLO-105) was performed preoperatively and 6 or 12 weeks postoperatively (stimulus size 0.2°(Goldmann II), employed intensity 0 and 12 dB, 20°fields in all tests). Surgery consisted of standard three port vitrectomy including removal of epiretinal membranes and the inner limiting membrane. Results-Postoperative paracentral scotomata were detected in areas that were tested normally before surgery. They were mostly located temporally and/or inferiorly and often appeared like nerve fibre bundle defects. The greatest dimension varied from 1.2°to 4.0°(360-1200 µm), smallest dimension from 0.25°to 2.0°( 75-600 µm). In three patients more than one scotoma was observed. Conclusion-Small, mostly asymptomatic, paracentral scotomata as a complication after vitrectomy for idiopathic macular hole have not been reported in the literature so far. Whether they are caused by trauma to the nerve fibres during surgery or other factors remains unknown. (Br J Ophthalmol 2001;85:231-233) Before Kelly and Wendel 1 reported the successful closure of full thickness idiopathic macular holes by removal of the cortical vitreous over the macula followed by gas tamponade, this condition was considered untreatable. Along with the development of operative techniques both the anatomical success and functional results have improved.2-4 Reported postoperative complications have included cataract, retinal detachment, retinal breaks, retinal pigment epitheliopathy, late reopening, and peripheral visual field loss.2 5-9 We report the occurrence of paracentral scotomata in patients after vitrectomy for macular hole, a finding that, to our knowledge, has not been described previously. Patients and methodsClinical examination was performed in 15 patients, six men and nine women, with a mean age of 71 years (range 63-79 years) preoperatively and 6 or 12 weeks postoperatively. The diagnosis of a macular hole was made by the presence of a full thickness neurosensory defect confirmed by high resolution cross sectional imaging of the retina provided by optical coherence tomography (OCT). Using Gass's classification scheme, 10 holes were designated as stage 3 and stage 4. Only idiopathic macular holes were included.Scanning laser ophthalmoscopy with a Rodenstock scanning laser ophthalmoscope (SLO-105) was performed at all visits. This method allows the examiner to view a real time image of the macula and assess fixation while performing microperimetry with high spatial resolution. A minimum of 80 test stimuli were distributed both in the macular and paramacular areas, covering the central 8°to 10°of the visual field. Stimulus size was 0.2°(Goldmann II), intensity was 0 and 12 dB. To cover the a large enough area, 20°fields were used for all tests. All patients were examined 1 day before
A recent report suggests that amblyopes are deficient in processing local orientation at supra-threshold contrasts. To determine whether amblyopes are also poor at integrating local orientation signals, we assessed performance for an orientation integration task in which the orientations of static signals are integrated across space. Our results show that amblyopic visual systems can integrate local static oriented signals with the same level of efficiency as normal visual systems. Although internal noise was slightly elevated, there was no indication that fewer samples were used to achieve optimal performance. This finding suggests normal integration of local orientation signals in amblyopia.
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