PurposeTo report the 12-months visual and anatomical outcomes of chronic diabetic macular oedema (DMO) treated with ILUVIEN in a real-world clinical practice in a single tertiary referral centre.MethodRetrospective data collection and analysis of consecutive 28 eyes of 23 diabetic patients received ILUVIEN implant for refractory DMO. Standard assessment included visual acuity (VA), central retinal thickness (CRT), slit-lamp biomicroscopy, and Goldmann tonometry for intraocular pressure (IOP) at 1, 6, and 12 months.ResultsBaseline mean VA was 47 (SD 18) letters improved to 55 (SD 17) letters (P=0.004) at 12 months. VA was improved in 16 eyes (57%), stabilised in 9 eyes (32%), and decreased in 3 eyes (11%). Seven eyes (25%) gained ≥15 letters, and 10 eyes (36%) gained >10 letters from baseline. The percentage of eyes achieved driving vision (≥70 Early Treatment Diabetic Retinopathy Study letters) was doubled from baseline 18 to 36% at 6 months and 32% at 12 months. Mean CRT decreased by 198 μm from baseline 494 μm (SD 191) to 296 μm (SD 121) at 12 months (P<0.001). Two eyes received additional anti-vascular endothelial growth factor injections after 10 months. Complications: Raised IOP in three eyes (11%) controlled with IOP-lowering drops, vitreous haemorrhage in one eye and one endophthalmitis (1 year vision improved to 6/24).ConclusionOur real-world results show that the visual and the anatomical improvements achieved by a single ILUVIEN implant injection were maintained up to 12 months with minimal adjunctive therapy. IOP monitoring remains essential in ILUVIEN patients, although our study shows a relatively low risk of IOP elevation post ILUVIEN injection, even in existing controlled ocular hypertension. Our results demonstrate that ILUVIEN is an effective long-term option in treating chronic refractory DMO.
SummaryBackgroundWe aimed to assess 24-month outcomes of wearing an organic light-emitting sleep mask as an intervention to treat and prevent progression of non-central diabetic macular oedema.MethodsCLEOPATRA was a phase 3, single-blind, parallel-group, randomised controlled trial undertaken at 15 ophthalmic centres in the UK. Adults with non-centre-involving diabetic macular oedema were randomly assigned (1:1) to wearing either a light mask during sleep (Noctura 400 Sleep Mask, PolyPhotonix Medical, Sedgefield, UK) or a sham (non-light) mask, for 24 months. Randomisation was by minimisation generated by a central web-based computer system. Outcome assessors were masked technicians and optometrists. The primary outcome was the change in maximum retinal thickness on optical coherence tomography (OCT) at 24 months, analysed using a linear mixed-effects model incorporating 4-monthly measurements and baseline adjustment. Analysis was done using the intention-to-treat principle in all randomised patients with OCT data. Safety was assessed in all patients. This trial is registered with Controlled-Trials.com, number ISRCTN85596558.FindingsBetween April 10, 2014, and June 15, 2015, 308 patients were randomly assigned to wearing the light mask (n=155) or a sham mask (n=153). 277 patients (144 assigned the light mask and 133 the sham mask) contributed to the mixed-effects model over time, including 246 patients with OCT data at 24 months. The change in maximum retinal thickness at 24 months did not differ between treatment groups (mean change −9·2 μm [SE 2·5] for the light mask vs −12·9 μm [SE 2·9] for the sham mask; adjusted mean difference −0·65 μm, 95% CI −6·90 to 5·59; p=0·84). Median compliance with wearing the light mask at 24 months was 19·5% (IQR 1·9–51·6). No serious adverse events were related to either mask. The most frequent adverse events related to the assigned treatment were discomfort on the eyes (14 with the light mask vs seven with the sham mask), painful, sticky, or watery eyes (14 vs six), and sleep disturbance (seven vs one).InterpretationThe light mask as used in this study did not confer long-term therapeutic benefit on non-centre-involving diabetic macular oedema and the study does not support its use for this indication.FundingThe Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research partnership.
AimTo assess the impact of deprivation on diabetic retinopathy presentation and related treatment interventions, as observed within the UK hospital eye service.MethodsThis is a multicentre, national diabetic retinopathy database study with anonymised data extraction across 22 centres from an electronic medical record system. The following were the inclusion criteria: all patients with diabetes and a recorded, structured diabetic retinopathy grade. The minimum data set included, for baseline, age and Index of Multiple Deprivation, based on residential postcode; and for all time points, visual acuity, ETDRS grading of retinopathy and maculopathy, and interventions (laser, intravitreal therapies and surgery). The main outcome measures were (1) visual acuity and binocular visual state, and (2) presence of sight-threatening complications and need for early treatment.Results79 775 patients met the inclusion criteria. Deprivation was associated with later presentation in patients with diabetic eye disease: the OR of being sight-impaired at entry into the hospital eye service (defined as 6/18 to better than 3/60 in the better seeing eye) was 1.29 (95% CI 1.20 to 1.39) for the most deprived decile vs 0.77 (95% CI 0.70 to 0.86) for the least deprived decile; the OR for being severely sight-impaired (3/60 or worse in the better seeing eye) was 1.17 (95% CI 0.90 to 1.55) for the most deprived decile vs 0.88 (95% CI 0.61 to 1.27) for the least deprived decile (reference=fifth decile in all cases). There is also variation in sight-threatening complications at presentation and treatment undertaken: the least deprived deciles had lower chance of having a tractional retinal detachment (OR=0.48 and 0.58 for deciles 9 and 10, 95% CI 0.24 to 0.90 and 0.29 to 1.09, respectively); in terms of accessing treatment, the rate of having a vitrectomy was lowest in the most deprived cohort (OR=0.34, 95% CI 0.19 to 0.58).ConclusionsThis large real-world study suggests that first presentation at a hospital eye clinic with visual loss or sight-threatening diabetic eye disease is associated with deprivation. These initial hospital visits represent the first opportunities to receive treatment and to formally engage with support services. Such patients are more likely to be sight-impaired or severely sight-impaired at presentation, and may need additional resources to engage with the hospital eye services over complex treatment schedules.
Purpose To determine whether a Pro Re Nata (PRN) regimen with three initial mandatory loading doses results in better functional and anatomical outcome compared with a PRN regimen without initial loading when using intravitreal bevacizumab in patients with minimal classic or occult choroidal neovascularisation secondary to age-related macular degeneration. Methods Patients were randomised (1 : 1) to Loading (LD group) or No Loading (NLD group) and treated with open label intravitreal bevacizumab. In the LD group, patients received two mandatory doses after the baseline dose before entering the PRN phase and in the NLD group, patients did not receive mandatory doses after the baseline dose. Six-weekly evaluations were performed up to week 54 and retreatment was done based on OCT criteria. Visual stability and reduction in central retinal thickness were compared between groups. Results 49 patients were in the NLD group and 50 patients were in the LD group. At the 12-month end point, 84% of the patients in the LD group achieved visual stability (o15 letter loss) compared with 67% of the patients in the NLD group (Po0.05). The mean reduction in central macular thickness was 105.35 mm in the LD group and 81.45 mm in the NLD group (P40.05). There was no significant difference in scores of VFQ-25 questionnaire testing between the two groups and no serious ocular or systemic side effects were observed. Conclusion The results supported our hypothesis that a loading dose leads to slightly better visual stability in terms of proportions of patients experiencing moderate visual loss, but did not support the hypothesised difference in anatomical outcome.
Purpose Various combination treatment regimens have been tried to improve the short-term efficacy of intravitreal monotherapy for the treatment of macular oedema (MO) secondary to retinal vein occlusion (RVO). Our study introduces the RandOL protocol (Ranibizumab and Ozurdex with Laser photocoagulation) of initial anti-VEGF therapy, controlling recurrent nonischaemic MO with an intravitreal steroid and applying laser therapy to non-perfused retina. We describe our 12-month follow-up experience on timing for adjunctive therapy and real-world effectiveness and safety data. Methods A retrospective analysis was carried out on 66 consecutive treatment-naive RVO patients with MO who received our RandOL treatment regimen. Baseline visual acuity (VA) and central retinal thickness (CRT) were compared with 12-month result. Results At 12 months, 77% had significant VA improvement, 52% had ≥ 3-line improvement, and 15% were worse. Significant improvements in CRT were observed in 97% (baseline median CRT = 531 μm (IQR 435-622) reduced to 245 μm (IQR 221-351, Po0.001) at 12 months); 76% achieved a dry fovea at 1 year. Mean number of total injections required was 5.5 (range 2-11) and 6% required ≥ 9 injections in 1 year. Although 70% received additional Ozurdex, 82% received ≥ 1 sessions of laser therapy. The BRVO subgroup achieved better VA and CRT improvement at 1 year, but small numbers limit definitive statistical conclusions.Conclusions Our real-world results using a combination treatment protocol for RVOrelated MO achieved similar desirable anatomical and visual outcomes as with a single-agent therapy with less intravitreal re-treatment rates at first year. Randomised controlled studies are needed to evaluate the role of laser and the ideal timing of combination therapy.
Purpose: To report a case of Candida albicans endophthalmitis with no identifiable predisposing risk factors. Case Report: A 57-year-old male presented with a 3-day history of worsening floaters and reduced visual acuity. Fundoscopy and optical coherence tomography showed presence of fluffy white preretinal and intraretinal infiltrates. With no past medical history or evidence of immunosuppression but having travelled abroad and suffered from diarrhoea, fungal aetiology was thought to be unlikely and as a result, treatment was commenced for toxoplasma. Despite treatment, his vision did not improve. Initial investigations including inflammatory markers, serology for toxoplasmosis, blood culture, chest radiograph and aqueous sampling could not identify a source of infection. However, polymerase chain reaction results from vitreous sampling revealed C. albicans. As a result, the patient was treated with intravenous voriconazole and intravitreal amphotericin B. As initial clinical improvement was limited, a vitrectomy was performed with further intravitreal amphotericin B. Clinical improvement was rapid following vitrectomy. After repeated Gram staining and culture of infected toenails, Gram-positive yeast cells were isolated. Conclusion: Although C. albicans is a frequent cause of endogenous endophthalmitis, patients often have one or more predisposing systemic condition assisting the diagnosis. The present case illustrates that (1) even in the absence of any predisposing risk factors, C.albicans should be considered as a possible differential diagnosis in recalcitrant uveitis, and (2) endogenous candida endophthalmitis can be a result of fungal infections from distant sites such as the toenails.
<H4>PURPOSE</H4> <p>To assess the comparability and intra-/ interobsever reliability of central anterior chamber depth measurements obtained using the Pentacam and IOLMaster.</p> <H4>METHODS</H4> <p>Anterior chamber depth was measured in 50 eyes (25 healthy volunteers)—three times on each eye by two independent observers with each method. A total of 12 measurements were performed on each eye. Analysis of variance was used to analyze the data. Mean values, standard deviations, and confidence limits (95% confidence interval) of the two modalities, two observers, and every observer/modality interaction were calculated.</p> <H4>RESULTS</H4> <p>The mean anterior chamber depth values were 3.23±0.031 mm for the IOLMaster and 3.21±0.033 mm for the Pentacam. No statistically significant difference was noted in measurements between the two modalities (<i>P</i>=.291) or between the two observers (<i>P</i>=.903). Observer/modality interaction was not significant (<i>P</i>=.643). The confi dence limits for observer 1 were 3.223±0.03 mm and 3.226±0.03 mm for observer 2. The confidence limits were: observer 1/IOLMaster, 3.23±0.04 mm; observer 2/IOLMaster, 3.24±0.04 mm; observer 1/Pentacam, 3.21±0.04 mm; and observer 2/Pentacam, 3.20±0.04 mm. The differences in measurements ranged from -0.14 to +0.10 mm for the IOLMaster and from -0.08 to +0.12 mm for the Pentacam. The worst deviation from the average eye reading of 3.23 mm was only 0.14 (4.3%).</p> <H4>CONCLUSIONS</H4> <p>Good agreement exists between anterior chamber depth measurements by the IOLMaster and Pentacam in the assessment of normal eyes, and they offer observer-independent results. Therefore, the modalities are interchangeable. [<cite>J Refract Surg</cite>. 2008;24:615-618.]</p> <h4>ABOUT THE AUTHORS</h4> <p>From Birmingham and Midland Eye Centre, Birmingham (Savant); and Wolverhampton & Midland Counties Eye Infirmary, Wolverhampton (Chavan, Pushpoth, Ilango), United Kingdom.</p> <p>The authors have no financial or proprietary interest in the materials presented herein.</p> <p>This study was presented as an E-paper at the International Society of Refractive Surgery of the American Academy of Ophthalmology Annual Regional Meeting; May 26-28, 2006; Istanbul, Turkey.</p> <p>Correspondence: Vijay Savant, FRCS(Ed), MRCOphth, Birmingham and Midland Eye Centre, Dudley Road, Birmingham B18 7QH, United Kingdom. Tel: 44 1215 543801; Fax: 44 1902 645018; E-mail: <a href="mailto:vijaysavant@hotmail.com">vijaysavant@hotmail.com</a></p> <p>Received: December 25, 2006</p> <p>Accepted: July 10, 2007</p> <p><b>Posted online: January 15, 2008</b></p>
Purpose -Complaints can provide the health provider with vital information on its performance and can point towards areas for improvement. The purpose of this study was to undertake a retrospective study of all formal complaints in an eye hospital over a three-year period in order to look at the complaint rate, demographics, their nature, how they were resolved and the lessons learned. Design/methodology/approach -Complaints received were entered onto the complaints module of the DATIX database system. Formal patient complaints between April 2003 and March 2006 available on the DATIX database were analysed retrospectively. Findings -The study found that there were total of 94 formal complaints out of 186,323 attendances at the hospital. The overall complaint rate was 5.09 per 10,000 attendances. 52(55.31 per cent) complaints were about rescheduling or cancellation of appointments. Complaints related to communication failure were 17(18.08 per cent) followed by clinical complaints, which totalled 13 (13.82 per cent). Four (4.25 per cent) complaints each under the category of amenities, administrative and waiting times were also recorded. The complaint rate for Outpatients Department was 1.5 per 10,000 attendances. The in-patient ward had a complaint rate of 0.91 per 1000. The complaint rate for A&E department was 0.88 per 10,000 attendances. The operation theatre plus laser sessions had a complaint rate of 0.95 per 10,000. 79 (84.04 per cent) complaints were resolved at the first stage of local resolution. Complaints during the study period brought about two clinical changes in practice. Originality/value -The use of complaints data as an important tool to learn from less satisfied patients is recommended. Comparing and sharing data on complaints between hospitals can help to highlight common deficient areas and can also be used to plan strategies.
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