The epiretinal membrane (ERM) is a degenerative condition associated with age, which can cause loss of vision and/or metamorphopsia. The treatment of symptomatic ERM involves surgical removal ...including a vitrectomy followed by peeling of the ERM using a microforceps. As the internal limiting membrane (ILM) is adherent to the ERM, it is sometimes removed with it (spontaneous peeling). If ILM remains in place, it can be removed to reduce ERM recurrence. However, it is important to clarify the safety of ILM peeling, while it increases surgical risks and cause histological disorganization of the retina that can lead to microscotomas, may be responsible for definitive visual discomfort.
PEELING is a prospective, randomized, controlled, single-blind, and multicentered trial with two parallel arms. This study investigates the benefit/risk ratio of active ILM peeling among individuals undergoing ERM surgery without spontaneous ILM peeling. Randomization is done in the operating room after ERM removal if ILM remains in place. After randomization, the two groups-"active peeling of the ILM" and "no peeling of the ILM"-are compared during a total of three follow-up visits scheduled at month 1, month 6, and month 12. Primary endpoint is the difference in microscotomas before surgery and 6 months after surgery. Patients with spontaneous peeling are not randomized and are included in the ancillary study with the same follow-up visits and the same examinations as the principal study. Relevant inclusion criteria involve individuals aged > 18 years living with idiopathic symptomatic ERM, including pseudophakic patients with transparent posterior capsule or open capsule or lensed patients with age-related cataracts. The calculated sample size corresponds to 53 randomized eyes (one eye/patient) per arm that means 106 randomized eyes (106 randomized patients) in total and a maximum of 222 included patients (116 spontaneous peeling).
ILM peeling is often practiced in ERM surgery to reduce ERM recurrence. It does not impair postoperative visual acuity, but it increases the surgical risks and causes anatomical damages. If active ILM peeling is significantly associated with more microscotomas, it may contraindicate the ILM peeling during primitive idiopathic ERM surgery.
ClinicalTrials.gov, NCT02146144. Registered on 22 May 2014. Recruitment is still ongoing.
Introduction
The aim of this study was to assess the efficacy and safety of fluocinolone acetonide implant (FAci) injected 1 month after the last dexamethasone intravitreal implant (DEXi) in chronic ...diabetic macular oedema (DME) patients.
Methods
Retrospective multicentric study conducted in pseudophakic patients with chronic DME frequently treated with dexamethasone intravitreal implant (DEXi; time to DME recurrence ≤ 6 months), receiving FAci 1 month after the last DEXi, with at least a 6-month follow-up. Best-corrected visual acuity (BCVA), central macular thickness (CMT) on optical coherence tomography, intraocular pressure (IOP) and additional treatments were assessed on the day of FAci injection (M0), 1 (M1) and 3 months (M3) later and then every 3 months.
Results
A total of 41 eyes from 34 patients were included. At M0, patients’ mean age was 68.7 ± 9.8 years, the mean DME duration was 63.9 ± 22.9 months, the mean interval between two DEXi was 14.2 ± 3.3 weeks. M12 data were available for 71% of patients. At baseline, the mean BCVA, CMT and IOP were 63.2 ± 16.6 letters, 299.4 ± 103.3 µm, and 16.2 ± 4.5 mmHg, respectively, and remained stable during the follow-up. At M12, 14% of patients required additional intravitreal treatments.
Conclusion
In pseudophakic patients with chronic DME showing good response to DEXi but requiring repeated injections every < 6 months, switching to FAci 1 month after the last DEXi was effective and safe. Further prospective randomized controlled studies are needed to confirm these findings, and to determine the best interval between the last DEXi and the first FAci.
The aim of the study was to assess the microperimetric consequences of active internal limiting membrane (ILM) peeling during idiopathic epimacular membrane (IEMM) surgery.
This retrospective ...monocentric study included 32 eyes of 31 consecutive patients who underwent IEMM surgery. Internal limiting membrane integrity was assessed by ILM Blue staining after IEMM removal: peeling was spontaneous (Group S) or active (Group A). Preprocedure and postprocedure (1 and 6 months) examinations were performed using visual acuity determination, spectral domain optical coherence tomography and microperimetry.
Twenty-two eyes had an "active ILM peeling" and 10 a "spontaneous ILM peeling." Both groups had comparable and significant improvements in visual acuity 6 months after surgery (+1.82 lines +9 letters Group A and +1.51 lines +8 letters Group S, P < 0.01) associated with a significant reduction in optical coherence tomography central thickness (-99.9 μm Group A, P < 0.01 and -62.2 μm Group S, P = 0.05). Six months after surgery, the microperimetry showed more numerous and deeper microscotomas in the Group A than in the Group S (change in the number of microscotomas: 2.09 vs. -0.10, P = 0.06; change in deficit severity score: 13.18 dB vs. -2 dB, P < 0.01 for Group A and S, respectively). The number of microscotomas and also severity were increased in 63.6% of Group A patients and in only 20% of Group S patients. Microscotomas were most frequently located in IEMM and/or ILM areas.
Internal limiting membrane peeling has progressively become generalized in IEMM surgery to reduce recurrences. This additional procedure does not change the postoperative visual acuity but increases the development of deeper microscotomas. The real impact on the quality of vision remains unclear.
Active ILM peeling in IEMM surgery may be responsible for visual impairment related to its microtraumatic effects.
APOLLON (NCT02924311) was a prospective observational study to evaluate the effectiveness of intravitreal aflibercept (IVT-AFL) treatment of diabetic macular edema (DME) over 24 months in routine ...clinical practice in France. The primary endpoint was mean change from baseline in best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study letters) by 12 months, and safety was monitored throughout the study. Of 402 patients enrolled across 61 participating clinics and hospitals in France, 168 patients were followed for at least 24 months and included in the effectiveness analyses (79 treatment-naïve and 89 previously treated). After 24 months of IVT-AFL treatment, the mean (± standard deviation SD) change in BCVA from baseline was + 6.5 (± 10.7) letters in treatment-naïve patients (p < 0.001) and + 1.6 (± 17.0) letters in previously treated patients (p = 0.415) from a baseline of 63.8 (± 13.6) and 60.5 (± 16.5) letters. The mean number of IVT-AFL treatments over 24 months was 11.3 (± 4.9) and 11.9 (± 4.7) for treatment-naïve and previously treated patients. This final analysis of the APOLLON study indicated that following 24 months of IVT-AFL treatment in routine clinical practice in France, treatment-naïve patients with DME achieved significant gains in visual acuity and previously treated patients maintained prior visual acuity gains.Trial registration number: NCT02924311.
Purpose
To measure the predictive values of relative afferent pupillary defect (RAPD) assessed semi‐quantitatively, and visual acuity (VA) at onset of central retinal vein occlusion (CRVO), for ...neovascularization.
Methods
Retrospective analysis of the TROXHEMO trial that included patients with CRVO within 30 days after the onset. Inclusion criteria were as follows: semi‐quantitative RAPD assessment at diagnosis and/or at one month. RAPD was ‘severe’ if ≥ 0.9 log. Exclusion criteria were as follows: prophylactic panretinal photocoagulation (PRP) before neovascularization.
Results
Among the 119 patients enrolled in the main centre, 101 were analysed. 26 had a neovascular complication during the twelve months of follow‐up: rubeosis (19), glaucoma (7) and posterior neovascularization (15). The mean time to onset of a neovascular complication was 4.7 months (1 to 12, median 3 months). All the patients who had a neovascular complication had RAPD at first examination or at one month (negative predictive value (NPV) = 100%) but the positive predictive value (PPV) was low (31%, 95% CI 21%; 42%). The association ‘severe RAPD or VA < 35 letters (ETDRS) at inclusion or at one month’ was the best compromise between PPV (53%, 39%; 68%) and NPV (96%, 92%; 100%).
Conclusion
To predict neovascularization, RAPD should be routinely evaluated with filters: the risk of neovascular complication is (a) almost nil if there is no RAPD, (b) very low if there is no severe RAPD and if VA is higher than 35 letters, and (c) higher than 50% if RAPD is ≥ 0.9 log or if VA is less than 35 letters.
Background/aimsTo monitor treatment-naïve patients with wet age-related macular degeneration (wet AMD) receiving intravitreal aflibercept (IVT-AFL) in France.MethodsRAINBOW (Real life use of ...intravitreal Aflibercept In FraNce - oBservatiOnal study in Wet age-related macular degeneration) is an ongoing, observational, retrospective and prospective 4-year study to assess visual (primary), anatomical and safety outcomes following IVT-AFL treatment in wet AMD patients. We report the interim 12-month outcomes in patients who have already been enrolled.ResultsSafety data were analysed from 586 patients (safety analysis set); and effectiveness data were analysed from 502 patients with at least one follow-up (full-analysis set) and from 353 patients with visual acuity data at baseline and month 12. The mean (SD) best-corrected visual acuity (BCVA) was 56.7 (18.2) letters and the mean (SD) central retinal thickness (CRT) was 395.6 (140.5)µm at baseline. Most patients (76.9%) received a loading dose (first three injections within 90 days). The mean (SD) number of IVT-AFL injections over 12 months was 6.0 (2.1) and 6.6 (1.8) (patients who received a loading dose). The mean (SD) change in BCVA was 5.5 (15.0) letters and 6.8 (14.5) letters (patients who received a loading dose) at month 12 (p<0.001 vs baseline). The mean (SD) CRT reduction was –108.7 (146.8)µm and –116.4 (150.4)µm (loading dose) at month 12 (p<0.001 vs baseline). Overall, 118 (20.1%) patients experienced at least one treatment-emergent adverse event (TEAE), 1.2% experienced ocular TEAEs and 3.9% experienced serious AEs.ConclusionThis 12-month interim analysis showed that IVT-AFL was associated with sustained improvements in a real-world setting. The RAINBOW results are consistent with the VIEW clinical studies.Trial registration numberNCT02279537 Pre-results.
Cette recherche a pour objet la compréhension des énoncés de problèmes arithmétiques complexes et leur résolution. Les problèmes complexes choisis combinent des problèmes simples de types Changement ...et Combinaison. Ce travail s’appuie sur le modèle de la Construction-Intégration de Kintsch. Les résultats montrent qu’il existe une relation entre le niveau d’expertise en compréhension de textes narratifs et la résolution des problèmes arithmétiques complexes. Comprendre un texte narratif ou un énoncé de problème complexe exige de la part des lecteurs la construction d’un réseau propositionnel hiérarchisé et les résultats suggèrent, entre autres, une sensibilité des élèves aux propositions textuelles et aux ellipses contenues dans les textes. La formation des macropropositions est un processus fondamental et les résultats montrent une relation entre le nombre d’objets contenus dans les énoncés de problème et la procédure préférentiellement choisie par les élèves. Ils suggèrent d’une part, la mise en oeuvre du processus de catégorisation au cours du processus de compréhension et d’autre part, l’affaiblissement des liaisons entre les macropropositions élaborées et le schéma de problème Parties-Tout qui leur sont liés. D’un point de vue pédagogique, les résultats montrent que les questions relatives à l’activation d’une part des concepts superordonnés et d’autre part des schémas de problèmes Parties-Tout ne sont pas à privilégier pour aider les élèves. Finalement, les connaissances du lecteur sont essentielles à la compréhension. Cet élément est confirmé ici et la compréhension des problèmes complexes nécessite des connaissances solides relativement aux problèmes arithmétiques simples.
This research deals with text comprehension processes and complex arithmetic word problems resolution by 9-10 years old children in Reunion Island based upon the CI model of Kintsch. The complex word arithmetic problems used in this research are a combination of Change simple problems and Combine simple problems. The results show a relation between subject’s level of expertise in narrative texts comprehension and complex arithmetic word problems resolution. In order to understand a narrative text or to resolve a complex arithmetic word problem, subjects have to elaborate a coherent hierarchical propositional network : bridging inferences and macropropositions are involved to achieve complex arithmetic word problems resolution too. More precisely, the results suggest children are sensitive to the number of propositions and to the ellipsises. Macropropositions formation is an integral process of reading. The results show a relation between number of objects in complex arithmetic problems and procedure naturally used by children to solve them. They suggest on the one hand, categorization processes are an integral part of reading and on the other hand, some links between macropropositions and arithmetic hypothesis become weaker. Consequently, questions about superordinate concepts and arithmetic hypothesis attached to them are not helpul to resolve complex arithmetic word problems. Finally, reader’s knowlegde is a key element of comprehension processes and to achieve complex arithmetic word problems, problem schemata about simple arithmetic word problems are crucial. The results show a relation between subject’s level of expertise in simple arithmetic word problems and complex arithmetic word problems resolution.
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