Clare Bailey

Real-world experience with 0.2 μ g/day fluocinolone acetonide intravitreal implant (ILUVIEN) in the United Kingdom

AimsTo compare safety outcomes and visual function data acquired in the real-world setting with FAME study results in eyes treated with 0.2u2009μg/day fluocinolone acetonide (FAc).MethodsFourteen UK clinical sites contributed to pseudoanonymised data collected using the same electronic medical record system. Data pertaining to eyes treated with FAc implant for diabetic macular oedema (DMO) was extracted. Intraocular pressure (IOP)-related adverse events were defined as use of IOP-lowering medication, any rise in IOP>30u2009mmu2009Hg, or glaucoma surgery. Other measured outcomes included visual acuity, central subfield thickness (CSFT) changes and use of concomitant medications.ResultsIn total, 345 eyes had a mean follow-up of 428 days. Overall, 13.9% of patients required IOP-lowering drops (included initiation, addition and switching of current drops), 7.2% had IOP elevation >30u2009mmu2009Hg and 0.3% required glaucoma surgery. In patients with prior steroid exposure and no prior IOP-related event, there were no new IOP-related events. In patients without prior steroid use and without prior IOP-related events, 10.3% of eyes required IOP-lowering medication and 4.3% exhibited IOP >30u2009mmu2009Hg at some point during follow-up. At 24 months, mean best-recorded visual acuity increased from 51.9 to 57.2 letters and 20.8% achieved ≥15-letter improvement. Mean CSFT reduced from 451.2 to 355.5u2009μm.ConclusionsWhile overall IOP-related emergent events were observed in similar frequency to FAME, no adverse events were seen in the subgroup with prior steroid exposure and no prior IOP events. Efficacy findings confirm that the FAc implant is a useful treatment option for chronic DMO.

Previous Intravitreal Therapy Is Associated with Increased Risk of Posterior Capsule Rupture during Cataract Surgery.

PURPOSEnTo investigate if previous intravitreal therapy is a predictor of posterior capsule rupture (PCR) during cataract surgery.nnnDESIGNnMulticenter, national electronic medical record (EMR) database study with univariate and multivariate regression modeling.nnnPARTICIPANTSnA total of 65 836 eyes of 44 635 patients undergoing cataract surgery.nnnMETHODSnAnonymized data were extracted for eyes undergoing cataract surgery from 20 hospitals using the same EMR for cases performed between 2004 and 2014. Variables included as possible risk indicators for PCR were age, sex, number of previous intravitreal injections, indication for intravitreal therapy, grade of healthcare professional administering intravitreal therapy, advanced cataract, and cataract surgeon grade.nnnMAIN OUTCOME MEASURESnPresence or absence of posterior capsular rupture during cataract surgery.nnnRESULTSnData were available on 65 836 cataract operations, of which 1935 had undergone previous intravitreal therapy (2.9%). In univariate regression analyses, patient age, advanced cataract, junior cataract surgeon grade, and number of previous intravitreal injections were significant predictors of PCR. By considering the number of previous intravitreal injections as a continuous variable, the odds ratio for PCR per intravitreal injection was 1.04 (Pxa0= 0.016) after adjusting for age, advanced cataract, and cataract surgeon grade. Repeat analysis considering intravitreal injections as a categoric variable showed 10 or more previous injections were associated with a 2.59 times higher likelihood of PCR (Pxa0= 0.003) after again adjusting for other significant independent predictors.nnnCONCLUSIONSnPrevious intravitreal therapy is associated with a higher likelihood of PCR during cataract surgery. This study provides data to help inform surgeons and patients about the risk of complications when undergoing cataract surgery after multiple prior intravitreal injections. Further investigation is required to determine the cause behind the increased PCR risk.

UK Age-Related Macular Degeneration Electronic Medical Record System (AMD EMR) Users Group Report IV: Incidence of Blindness and Sight Impairment in Ranibizumab-Treated Patients

PURPOSEnTo study the incidence of blindness and sight impairment in treatment-naive patients receiving ranibizumab (Lucentis) for neovascular age-related macular degeneration (nAMD) in the United Kingdom (UK) National Health Service.nnnDESIGNnMulticenter nAMD database study.nnnPARTICIPANTSnA total of 11u2009135 patients who collectively received 92u2009976 treatment episodes to 12u2009951 eyes.nnnMETHODSnData were extracted from 14 UK centers using the same electronic medical record system (EMR). The EMR-mandated collection of a data set (defined before first data entry) including: age, Early Treatment Diabetic Retinopathy Study visual acuity letter score (VA) for both eyes at all visits, and injection episodes. Participating centers used overwhelmingly a pro re nata re-treatment posology at intended monthly follow-up visits following a loading phase of 3 monthly injections.nnnMAIN OUTCOME MEASURESnIncidence of blindness and sight impairment (VA in the better-seeing eye <38 letters [≤20/200 Snellen, approximately], and <68 letters [≤20/50 Snellen, approximately] at 2 consecutive visits, or 1 visit if no further follow-up data) in each year after initiating treatment.nnnRESULTSnInformation from >300u2009000 clinic visits (2.8 million data points) collected over 5 years was collated from 14 centers. Mean age at first treatment was 79.7 years (standard deviationxa0= 9.19 years), with a female preponderance (63%). The mean (median) VA at baseline in the better-seeing eye was 67.2 (72.0) letters, 20/40- (20/40+) approximate Snellen conversion. The cumulative incidence of new blindness and sight impairment in patients with treated nAMD in at least 1 eye at years 1 to 4 after first injection were 5.1%, 8.6%, 12% and 15.6% for new blindness and 29.6%, 41.0%, 48.7%, and 53.7% for new sight impairment, but with significant reductions in the rates between year cohorts initiating treatment (blindness [Pxa0= 4.72xa0× 10-08], sight impaired [Pxa0= 3.27xa0× 10-06]).nnnCONCLUSIONSnTo the best of our knowledge, this is the first multicenter real-world study on the incidence of blindness and sight impairment based on VA data in patients treated with ranibizumab for nAMD, and its results show low incidences of both blindness and sight impairment, which both declined during the study period.

Visual Acuity Improvement When Switching From Ranibizumab To Aflibercept Is Not Sustained

Purpose: To assess whether visual benefits exist in switching to aflibercept in patients who have been chronically treated with ranibizumab for neovascular age-related macular degeneration. Methods: A multicenter, national, electronic medical record database study was performed. Patients undergoing six continuous monthly ranibizumab injections and then switched to continuous aflibercept were matched to those on continuous ranibizumab therapy. Matching was performed in a 2:1 ratio and based on visual acuity 6 months before and at the time of the switch, and the number of previous ranibizumab injections. Results: Patients who were switched to aflibercept demonstrated transiently significant improvement in visual acuity that peaked at an increase of 0.9 Early Treatment Diabetic Retinopathy Study letters 3 months after the switch, whereas control patients continued on ranibizumab treatment showed a steady decline in visual acuity. Visual acuity differences between the groups were significant (P < 0.05) at 2, 3, and 5 months after the switch. Beginning at 4 months after the switch, the switch group showed a visual acuity decline similar to the control group. Conclusion: Transient, nonsustained improvement in visual acuity occurs when switching between anti–vascular endothelial growth factor agents, which may have implications in treating patients on chronic maintenance therapy on one anti–vascular endothelial growth factor medication.

Brief Report: Vision in Children with Autism Spectrum Disorder: What Should Clinicians Expect?

Anomalous visual processing has been described in individuals with autism spectrum disorder (ASD) but relatively few studies have profiled visual acuity (VA) in this population. The present study describes presenting VA in children with ASD (nxa0=xa0113) compared to typically developing controls (nxa0=xa0206) and best corrected visual acuity (BCVA) in a sub-group of children with ASD (nxa0=xa029). There was no statistically significant difference in presenting VA between groups (zxa0=xa0−1.75, pxa0=xa00.08); ASD group median VA (interquartile range, IQR) −0.05 logMAR (IQR: −0.125 to 0.025 logMAR) and typically developing control group −0.075 logMAR (IQR: −0.150 to −0.025 logMAR). Median BCVA was −0.175 logMAR (IQR: −0.200 to −0.125 logMAR) for the ASD sub-group. Clinicians should not anticipate reduced VA when assessing children with ASD.

Health-related quality of life, visual function and treatment satisfaction following intravitreal dexamethasone implant for diabetic macular edema

Purpose The aim of this study was to explore and describe quantitatively patient-reported outcome measures (PROMs), ie, health-related quality of life (QoL), visual function and treatment satisfaction, in patients with diabetic macular edema (DME) receiving two different regimens of Ozurdex (intravitreal dexamethasone implant). Methods In this multicenter, prospective study, 100 patients with center-involving refractory DME were randomized 1:1 to either five monthly fixed dosing or optical coherence tomography (OCT)-guided pro re nata (PRN) regimen of dexamethasone intravitreal implant therapy. The primary outcome was the difference between arms in change in PROMs and health-related QoL from baseline to 12 months, as measured by the Retinopathy-Dependent Quality of Life (RetDQoL) questionnaire, Visual Function Questionnaire-25 (VFQ-25) and Retinopathy Treatment Satisfaction Questionnaire (RetTSQ). Results There was no statistically significant difference in the RetDQoL score and VFQ-25 score at month 12 compared to those at baseline, whereas the total mean RetTSQ score increased significantly at the exit visit. The two treatment arms did not differ significantly regarding the change in PROMs and health-related QoL questionnaires. Logistic regression analysis showed that visual acuity (VA) of ≥55 letters, central foveal thickness <300 μm and macular volume <9.2 mm3 at the exit visit (month 12) predicted a higher change in RetTSQ. Conclusion This study showed that there is a statistically significant improvement in treatment satisfaction, as measured by RetTSQ, in patients with DME treated with dexamethasone intravitreal implant, independent of the dose regimen, namely, fixed or PRN. However, it should be noted that the clinically meaningful change could not be assessed accurately, since no thresholds for clinically meaningful change currently exist for the RetTSQ. On the other hand, there was no significant change in health-related QoL, as measured using VFQ-25 and RetDQoL. Factors affecting the patients’ treatment satisfaction were the final VA, the central foveal thickness and the macular volume.

Profile of refractive errors in European Caucasian children with Autistic Spectrum Disorder; increased prevalence and magnitude of astigmatism

Autistic Spectrum Disorder (ASD) is a common neurodevelopmental disorder characterised by impairment of communication, social interaction and repetitive behaviours. Only a small number of studies have investigated fundamental clinical measures of vision including refractive error. The aim of this study was to describe the refractive profile of a population of children with ASD compared to typically developing (TD) children.

Intralesional Macular Atrophy in Anti–Vascular Endothelial Growth Factor Therapy for Age-Related Macular Degeneration in the IVAN Trial

PURPOSEnTo report on the development and progression of macular atrophy (MA) and its relationship with morphologic and functional measures in study and fellow eyes in the Inhibition of vascular endothelial growth factor (VEGF) in Age-related Choroidal Neovascularisation trial.nnnDESIGNnReading center analysis of data from a randomized controlled trial.nnnPARTICIPANTSnParticipants with previously untreated neovascular age-related macular degeneration (nAMD) in the study eye.nnnMETHODSnColor, fluorescein angiography (FA) and OCT images acquired at baseline and during the 2-year follow-up were graded systematically for presence of MA. Regression models were constructed to explore relationships between MA and lesion morphology and vision measures (best-corrected distance and near acuity, reading speed and index, contrast sensitivity).nnnMAIN OUTCOME MEASURESnPrimary outcome was development of intralesional MA (≥175 μm greatest linear dimension of choroidal vessels seen on FA and/or color, aided by OCT) lying within the maximum footprint of the neovascular lesion.nnnRESULTSnStudy eye data were available for 594 of 610 participants; 57 (9.6%) showed intralesional MA at baseline. Incident intralesional MA occurred in 24.4% by the final visit and extralesional MA in only 1.54%. In fellow eyes, an established nAMD lesion was present at baseline in 248 of whom 42 (16.9%) showed intralesional MA at baseline and 32 (12.9%) developed incident intralesional MA. The odds of incident intralesional MA by final visit were lower in study eyes that had ≥50% classic CNV at baseline (odds ratio [OR], 0.39; 95% confidence interval [CI], 0.19-0.80; Pxa0= 0.010), subretinal fluid at final visit (OR, 0.41; 95% CI, 0.25-0.76; Pxa0= 0.004), or pigment epithelial detachment at final visit (OR, 0.40; 95% CI, 0.21-0.74; Pxa0= 0.004). Secondary analyses of incident or progressed intralesional MA in study eyes supported these findings, with odds increasing if the fellow eye had baseline intralesional MA (OR, 2.43; 95% CI, 1.09-5.44; Pxa0= 0.030). No significant associations were observed between development of intralesional MA and any other morphologic or visual function measure.nnnCONCLUSIONSnMacular atrophy frequently develops within an nAMD lesion in eyes receiving anti-VEGF therapy over 2 years. No associations between incident MA and drug or treatment frequency or visual function were detected, providing some reassurance to clinicians; however, the longer-term effects remain unknown.

Visual Acuity Outcomes in Diabetic Macular Edema With Fluocinolone Acetonide 0.2 μg/Day Versus Ranibizumab Plus Deferred Laser (DRCR Protocol I)

BACKGROUND AND OBJECTIVEnVisual outcomes of the FAME study (0.2 μg/day fluocinolone acetonide [FAc]) and Protocol I (0.5 mg ranibizumab plus deferred laser) were compared using the area under the curve (AUC) analysis method.nnnPATIENTS AND METHODSnBest-corrected visual acuity (BCVA) data collected during a period of 3 years of follow-up for patients enrolled in FAME or Protocol I were used to calculate AUC of the change in BCVA over a time curve.nnnRESULTSnIn the overall population, there was a greater treatment effect for ranibizumab plus deferred laser compared with FAc. However, for subgroups of pseudophakic eyes, eyes with chronic diabetic macular edema (DME), and pseudophakic eyes with chronic DME, ranibizumab plus deferred laser and FAc were not found to be significantly different. The ranibizumab group received a median of 14 injections during a 36-month period compared with a mean of 1.3 injections in the FAc group.nnnCONCLUSIONnIn pseudophakic and chronic DME subgroups, FAc was comparable to ranibizumab plus deferred laser with fewer injections. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:698-706.].

Low-Level Nighttime Light Therapy for Age-Related Macular Degeneration: A Randomized Clinical Trial

PurposenTo investigate the safety, acceptability, and effectiveness of light therapy on the progression of AMD over 12 months.nnnMethodsnThis was a phase I/IIa, prospective, proof-of-concept, single-center, unmasked randomized controlled trial. Sixty participants (55 to 88 years) with early AMD in the study eye and neovascular AMD (nAMD) in the fellow eye were recruited from a hospital nAMD clinic. Eligible participants were randomized (ratio 1:1) to receive light therapy or to an untreated control group. Light therapy was delivered via a light-emitting mask (peak 505 nm, 23 scotopic Td), which was worn each night for 12 months. Co-primary outcome measures were disease progression (onset of nAMD or increased drusen volume beyond test-retest limits) and change in time constant of cone dark adaptation. Other main outcomes included adverse events, compliance, and subjective sleep quality data.nnnResultsnDisease progression over 12 months was seen in 38.1% (18.1%-61.6% confidence interval [CI]) of intervention participants and 48.3% (29.4%-67.5% CI) of controls (Mantel-Haenszel test, common odds ratio = 0.763, P = 0.495). A significantly larger delay in cone adaptation was observed in the intervention group (1.66 ± 0.61 minutes) than in the control group (0.66 ± 0.49 minutes) over the follow-up period. No reported adverse events were deemed to be associated with the intervention.nnnConclusionsnAlthough acceptable to the patients, light therapy did not have a substantial effect on the progression of early AMD over 12 months. Further investigation is necessary to discover the permanency and cause of the adverse effect of light therapy on dark adaptation.