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PURPOSE: To determine clinical effectiveness, safety, and cost-effectiveness of subthreshold micropulse laser (SML), compared with standard laser (SL), for diabetic macular edema (DME) with central retinal thickness (CRT) < 400 µm. DESIGN: Pragmatic, multicenter, allocation-concealed, double-masked, randomized, noninferiority trial. PARTICIPANTS: Adults with center-involved DME < 400 µm and best-corrected visual acuity (BCVA) of > 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in one/both eyes. METHODS: Randomization 1:1 to 577 nm SML or SL treatment. Retreatments were allowed. Rescue with intravitreal anti-vascular endothelial growth factor therapies or steroids was permitted if 10 or more ETDRS letter loss occurred, CRT increased > 400 µm, or both. MAIN OUTCOME MEASURES: Primary outcome was mean change in BCVA in the study eye at 24 months (noninferiority margin 5 ETDRS letters). Secondary outcomes were mean change from baseline to month 24 in binocular BCVA; CRT and mean deviation of Humphrey 10-2 visual field in the study eye; percentage meeting driving standards; EuroQoL EQ-5D-5L, 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25), and Vision and Quality of Life Index (VisQoL) scores; cost per quality-adjusted life-years (QALYs) gained; adverse effects; and number of laser and rescue treatments. RESULTS: The study recruited fully (n = 266); 87% of SML-treated and 86% of SL-treated patients had primary outcome data. Mean ± standard deviation BCVA change from baseline to month 24 was -2.43 ± 8.20 letters and -0.45 ± 6.72 letters in the SML and SL groups, respectively. Subthreshold micropulse laser therapy was deemed not only noninferior but also equivalent to SL therapy because the 95% confidence interval (CI; -3.9 to -0.04 letters) lay wholly within both upper and lower margins of the permitted maximum difference (5 ETDRS letters). No statistically significant difference was found in binocular BCVA (0.32 ETDRS letters; 95% CI, -0.99 to 1.64 ETDRS letters; P = 0.63); CRT (-0.64 µm; 95% CI, -14.25 to 12.98 µm; P = 0.93); mean deviation of the visual field (0.39 decibels (dB); 95% CI, -0.23 to 1.02 dB; P = 0.21); meeting driving standards (percentage point difference, 1.6%; 95% CI, -25.3% to 28.5%; P = 0.91); adverse effects (risk ratio, 0.28; 95% CI, 0.06-1.34; P = 0.11); rescue treatments (percentage point difference, -2.8%; 95% CI, -13.1% to 7.5%; P = 0.59); or EQ-5D, NEI-VFQ-25, or VisQoL scores. Number of laser treatments was higher in the SML group (0.48; 95% CI, 0.18-0.79; P = 0.002). Base-case analysis indicated no differences in costs or QALYs. CONCLUSIONS: Subthreshold micropulse laser therapy was equivalent to SL therapy, requiring slightly higher laser treatments.
Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Adulto , Humanos , Edema Macular/tratamento farmacológico , Retinopatia Diabética/cirurgia , Retinopatia Diabética/tratamento farmacológico , Qualidade de Vida , Fotocoagulação a Laser/efeitos adversos , Acuidade Visual , Retina , Injeções Intravítreas , Inibidores da Angiogênese , Ranibizumab/uso terapêuticoRESUMO
BACKGROUND: The National Institute for Health and Care Excellence recommends macular laser to treat diabetic macular oedema with a central retinal subfield thickness of < 400 µm on optical coherence tomography. The DIAMONDS (DIAbetic Macular Oedema aNd Diode Subthreshold micropulse laser) trial compared standard threshold macular laser with subthreshold micropulse laser to treat diabetic macular oedema suitable for macular laser. OBJECTIVES: Determining the clinical effectiveness, safety and cost-effectiveness of subthreshold micropulse laser compared with standard threshold macular laser to treat diabetic macular oedema with a central retinal subfield thickness of < 400 µm. DESIGN: A pragmatic, multicentre, allocation-concealed, double-masked, randomised, non-inferiority, clinical trial. SETTING: Hospital eye services in the UK. PARTICIPANTS: Adults with diabetes and centre-involving diabetic macular oedema with a central retinal subfield thickness of < 400 µm, and a visual acuity of > 24 Early Treatment Diabetic Retinopathy Study letters (Snellen equivalent > 20/320) in one/both eyes. INTERVENTIONS: Participants were randomised 1 : 1 to receive 577 nm subthreshold micropulse laser or standard threshold macular laser (e.g. argon laser, frequency-doubled neodymium-doped yttrium aluminium garnet 532 nm laser); laser treatments could be repeated as needed. Rescue therapy with intravitreal anti-vascular endothelial growth factor therapies or steroids was allowed if a loss of ≥ 10 Early Treatment Diabetic Retinopathy Study letters between visits occurred and/or central retinal subfield thickness increased to > 400 µm. MAIN OUTCOME MEASURES: The primary outcome was the mean change in best-corrected visual acuity in the study eye at 24 months (non-inferiority margin 5 Early Treatment Diabetic Retinopathy Study letters). Secondary outcomes included the mean change from baseline to 24 months in the following: binocular best-corrected visual acuity; central retinal subfield thickness; the mean deviation of the Humphrey 10-2 visual field in the study eye; the percentage of people meeting driving standards; and the EuroQol-5 Dimensions, five-level version, National Eye Institute Visual Function Questionnaire - 25 and Vision and Quality of Life Index scores. Other secondary outcomes were the cost per quality-adjusted life-years gained, adverse effects, number of laser treatments and additional rescue treatments. RESULTS: The DIAMONDS trial recruited fully (n = 266); 87% of participants in the subthreshold micropulse laser group and 86% of participants in the standard threshold macular laser group had primary outcome data. Groups were balanced regarding baseline characteristics. Mean best-corrected visual acuity change in the study eye from baseline to month 24 was -2.43 letters (standard deviation 8.20 letters) in the subthreshold micropulse laser group and -0.45 letters (standard deviation 6.72 letters) in the standard threshold macular laser group. Subthreshold micropulse laser was deemed to be not only non-inferior but also equivalent to standard threshold macular laser as the 95% confidence interval (-3.9 to -0.04 letters) lay wholly within both the upper and lower margins of the permitted maximum difference (5 Early Treatment Diabetic Retinopathy Study letters). There was no statistically significant difference between groups in any of the secondary outcomes investigated with the exception of the number of laser treatments performed, which was slightly higher in the subthreshold micropulse laser group (mean difference 0.48, 95% confidence interval 0.18 to 0.79; p = 0.002). Base-case analysis indicated no significant difference in the cost per quality-adjusted life-years between groups. FUTURE WORK: A trial in people with ≥ 400 µm diabetic macular oedema comparing anti-vascular endothelial growth factor therapy alone with anti-vascular endothelial growth factor therapy and macular laser applied at the time when central retinal subfield thickness has decreased to < 400 µm following anti-vascular endothelial growth factor injections would be of value because it could reduce the number of injections and, subsequently, costs and risks and inconvenience to patients. LIMITATIONS: The majority of participants enrolled had poorly controlled diabetes. CONCLUSIONS: Subthreshold micropulse laser was equivalent to standard threshold macular laser but required a slightly higher number of laser treatments. TRIAL REGISTRATION: This trial is registered as EudraCT 2015-001940-12, ISRCTN17742985 and NCT03690050. FUNDING: This project was funded by the National Institute for Health and Care Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 50. See the NIHR Journals Library website for further project information.
The retina is a layer at the back of the eye. Its centre is called the macula and is responsible for central vision. Some people with diabetes develop diabetic macular oedema. In diabetic macular oedema fluid leaks from retinal blood vessels and builds up at the macula, resulting in sight loss. Diabetic macular oedema can be mild or severe; this can be determined measuring the thickness of the macula, which is measured in micrometres (µm). One micrometre is one thousandth of a millimetre. In mild diabetic macular oedema, the thickness of the macula increases, but is less than 400 µm. Patients with mild diabetic macular oedema can be treated with a laser and there are two laser types. The standard threshold macular laser has been available for many years. It clears the diabetic macular oedema but produces a 'burn' in the retina. The subthreshold micropulse laser is newer. It does not produce a burn but also clears the diabetic macular oedema. The lack of a burn, however, has led to doubts about whether or not this laser works as well as the standard threshold macular laser because 'no burn' was taken to mean 'less benefit'. These doubts led to our establishing the DIAMONDS (DIAbetic Macular Oedema aNd Diode Subthreshold micropulse laser) trial, which compared these two lasers for people with mild diabetic macular oedema. A total of 266 people suitable for either laser joined the study at 16 NHS hospitals across the UK; 133 received standard threshold macular laser and 133 received subthreshold micropulse laser. The choice of laser was determined by chance. The DIAMONDS trial found that the subthreshold micropulse laser was as good as the standard threshold macular laser (i.e. 'clinically equivalent') in terms of improving people's vision, reducing macula thickness, allowing people to meet driving standards and maintaining their quality of life, both in general terms and for vision in particular. There was a small increase (less than one session on average per person) in the number of laser treatment sessions needed with subthreshold micropulse laser. The costs of both laser treatments were about the same.
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Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Humanos , Adulto , Edema Macular/cirurgia , Retinopatia Diabética/cirurgia , Ranibizumab/efeitos adversos , Bevacizumab/efeitos adversos , Qualidade de Vida , Fatores de Crescimento Endotelial/uso terapêutico , Fotocoagulação a Laser/efeitos adversos , Fotocoagulação a Laser/métodos , LasersRESUMO
Purpose: The objectives of this study were the creation and validation of a screening tool for age-related macular degeneration (AMD) for routine assessment by primary care physicians, ophthalmologists, other healthcare professionals, and the general population. Methods: A simple, self-administered questionnaire (Simplified Théa AMD Risk-Assessment Scale [STARS] version 4.0) which included well-established risk factors for AMD, such as family history, smoking, and dietary factors, was administered to patients during ophthalmology visits. A fundus examination was performed to determine presence of large soft drusen, pigmentary abnormalities, or late AMD. Based on data from the questionnaire and the clinical examination, predictive models were developed to estimate probability of the Age-Related Eye Disease Study (AREDS) score (categorized as low risk/high risk). The models were evaluated by area under the receiving operating characteristic curve analysis. Results: A total of 3854 subjects completed the questionnaire and underwent a fundus examination. Early/intermediate and late AMD were detected in 15.9% and 23.8% of the patients, respectively. A predictive model was developed with training, validation, and test datasets. The model in the test set had an area under the curve of 0.745 (95% confidence interval [CI] = 0.705-0.784), a positive predictive value of 0.500 (95% CI = 0.449-0.557), and a negative predictive value of 0.810 (95% CI = 0.770-0.844). Conclusions: The STARS questionnaire version 4.0 and the model identify patients at high risk of developing late AMD. Translational Relevance: The screening instrument described could be useful to evaluate the risk of late AMD in patients >55 years without having an eye examination, which could lead to more timely referrals and encourage lifestyle changes.
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Degeneração Macular , Drusas Retinianas , Autoavaliação Diagnóstica , Seguimentos , Humanos , Degeneração Macular/diagnóstico , Degeneração Macular/epidemiologia , Drusas Retinianas/diagnóstico , Fatores de RiscoRESUMO
PURPOSE: A vignette study to examine treatment decisions made by UK hospital optometrists in patients with neovascular age-related macular degeneration (nAMD) and the effect of optometrists' experience on agreement. METHODS: Patients with nAMD attending Manchester Royal Eye Hospital, Manchester, UK were identified as potential candidates for the case series of vignettes. The cases were chosen to reflect a varied case-mix with respect to difficulty as well as ensuring good quality of the images. Each vignette included a history summary consisting of the number of previous injections given and visual acuity measurements at baseline, the previous visit, and the current visit. Images were compiled to show baseline fundus photographs and ocular coherence tomography (OCT) images with the current visit images on which the treatment decision was to be made along with the images from the previous visit. Hospital optometrists were recruited and asked to complete the series of vignettes, deciding if treatment was required at that visit and how confident they felt with that decision. Their responses were compared to the reference standard created by a consensus of consultant ophthalmologists with a sub-speciality interest in medical retina. RESULTS: Regarding treatment decision for optometrists, the percentage correct value was 75% with the sensitivity being 75.6% (95% CI 70.1-80.3) and the specificity as 75.1% (95% CI 72.1-77.8). No statistically significant difference was found between differing levels of experience. However, there was a significant difference in confidence levels between groups. Potentially sight threatening decisions accounted for 6.4% of the optometrists' decisions, 3.5% were made with a high confidence rating suggesting no discussion with an ophthalmologist was required. CONCLUSIONS: Although the optometrists showed modest agreement with the reference standard in a series of cases that have higher than average complexity, the optometrists showed a similar amount of variability within their treatment decisions compared to the reference standard. The optometrists were therefore not inferior in their performance compared to the ophthalmologists and this can be seen as supporting evidence for their extended role within this clinical area. Experience did not have an effect on 'correct' treatment decisions although there was a statistically significant effect on increasing confidence of treatment decision.
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Inibidores da Angiogênese/administração & dosagem , Competência Clínica , Tomada de Decisões , Hospitais , Oftalmologistas/normas , Optometristas/normas , Degeneração Macular Exsudativa/tratamento farmacológico , Humanos , Injeções Intravítreas , Curva ROC , Tomografia de Coerência Óptica , Reino Unido , Degeneração Macular Exsudativa/diagnósticoRESUMO
INTRODUCTION: The purpose of this review was to explore the potential link between macular atrophy (MA) of the retinal pigment epithelium in patients with neovascular age-related macular degeneration (nAMD) with the disease characteristics and morphological features. METHODS: To this end, we performed a search of peer-reviewed articles published on the PubMed database and included all relevant papers. We then examined these papers for possible risk factors for MA development in the context of nAMD treated with anti-vascular endothelial growth factor drugs, as well as possible protective factors. RESULTS: Our review of the relevant publications revealed that areas of MA can be directly visualized through multiple imaging modalities. Associations have been identified between MA of the retinal pigment epithelium and choroidal neovascular membrane characteristics, intra- and subretinal fluid, pigment epithelial detachment, choroidal thickness, subretinal hyperreflective material, outer retinal tubulations, hemorrhage, subretinal drusenoid deposits, refractile drusen, hyperreflective foci, retinal angiomatous proliferation, polypoidal choroidal vasculopathy, geographic atrophy in the fellow eye, genetic factors, and age. CONCLUSION: The findings of this review indicate that a multimodal approach is recommended for the assessment of MA. The conclusions drawn to date on the correlation between MA development or progression of MA and specific risk factors and possible protective factors are mixed. More clinical research is needed to reach a better understanding of this association.
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BACKGROUND: In the UK, macular laser is the treatment of choice for people with diabetic macular oedema with central retinal subfield thickness (CST) < 400 µm, as per National Institute for Health and Care Excellence guidelines. It remains unclear whether subthreshold micropulse laser is superior and should replace standard threshold laser for the treatment of eligible patients. METHODS: DIAMONDS is a pragmatic, multicentre, allocation-concealed, randomised, equivalence, double-masked clinical trial that aims to determine the clinical effectiveness and cost-effectiveness of subthreshold micropulse laser compared with standard threshold laser, for the treatment of diabetic macular oedema with CST < 400 µm. The primary outcome is the mean change in best-corrected visual acuity in the study eye from baseline to month 24 post treatment. Secondary outcomes (at 24 months) include change in binocular best corrected visual acuity; CST; mean deviation of the Humphrey 10-2 visual field; change in percentage of people meeting driving standards; European Quality of Life-5 Dimensions, National Eye Institute Visual Functioning Questionnaire-25 and VisQoL scores; incremental cost per quality-adjusted life year gained; side effects; number of laser treatments and use of additional therapies. The primary statistical analysis will be per protocol rather than intention-to-treat analysis because the latter increases type I error in non-inferiority or equivalence trials. The difference between lasers for change in best-corrected visual acuity (using 95% CI) will be compared to the permitted maximum difference of five Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Linear and logistic regression models will be used to compare outcomes between treatment groups. A Markov-model-based cost-utility analysis will extend beyond the trial period to estimate longer-term cost-effectiveness. DISCUSSION: This trial will determine the clinical effectiveness and cost-effectiveness of subthreshold micropulse laser, when compared with standard threshold laser, for the treatment of diabetic macular oedema, the main cause of sight loss in people with diabetes mellitus. TRIAL REGISTRATION: International Standard Randomised Controlled Trials, ISRCTN17742985 . Registered on 19 May 2017 (retrospectively registered).
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Retinopatia Diabética/cirurgia , Fotocoagulação a Laser/métodos , Edema Macular/cirurgia , Ensaios Clínicos Pragmáticos como Assunto , Análise Custo-Benefício , Interpretação Estatística de Dados , Método Duplo-Cego , Humanos , Modelos Logísticos , Avaliação de Resultados em Cuidados de Saúde , Tamanho da Amostra , Acuidade VisualRESUMO
IMPORTANCE: The study highlights the role of optical coherence angiography in the management of patients with neovascular age-related macular degeneration (nAMD) who have developed sub-retinal fibrosis. BACKGROUND: Development of sub-retinal fibrosis in the context of nAMD is known to adversely affect visual function. The aim of this study is to assess structure and flow features obtained through swept-source optical coherence tomography angiography (OCTA) in patients with sub-retinal fibrosis and associate these with visual acuity (VA). DESIGN: Institutional retrospective cohort study. PARTICIPANTS: A total 39 eyes of 39 patients with nAMD with sub-retinal fibrosis imaged with OCTA were included in this study. METHODS: Patients underwent swept-source OCTA. Thickness of sub-retinal hyper-reflective material (SHRM) and presence and configuration of a choroidal neovascular membrane were recorded in each case. MAIN OUTCOME MEASURES: A univariate multiple regression was performed seeking associations between VA and structural and flow OCTA features. RESULTS: Average VA on the date of OCTA was 53 ± 22 ETDRS letters. Average thickness of centre-involving SHRM was 157 ± 73 µm. A choroidal neovascular membrane was detectable in 26 cases and not detectable in 13. VA was independently influenced by thickness of SHRM (P = 0.034) and presence of a detectable choroidal neovascular membrane (P = 0.02) on OCTA. CONCLUSIONS AND RELEVANCE: Poorer VA in patients with nAMD and sub-retinal fibrosis is associated with presence of a detectable neovascular membrane on OCTA. The role of OCTA to guide nuanced management decisions in this patient population may be significant.
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Neovascularização de Coroide/diagnóstico , Retina/patologia , Degeneração Macular Exsudativa/diagnóstico , Idoso , Idoso de 80 Anos ou mais , Inibidores da Angiogênese/uso terapêutico , Neovascularização de Coroide/tratamento farmacológico , Neovascularização de Coroide/fisiopatologia , Feminino , Fibrose/patologia , Angiofluoresceinografia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Tomografia de Coerência Óptica , Acuidade Visual/fisiologia , Degeneração Macular Exsudativa/tratamento farmacológico , Degeneração Macular Exsudativa/fisiopatologiaRESUMO
PURPOSE: To evaluate the efficacy and safety of intravitreal bevacizumab (Avastin; Genentech, South San Francisco, CA) in patients with neovascular age-related macular degeneration (nAMD) using 2 different treatment regimens in which patients were assessed clinically at up to 12-week intervals. DESIGN: Randomized, controlled, noninferiority trial. PARTICIPANTS: A total of 331 patients with nAMD. METHODS: Patients were treated with 1.25 mg intravitreal bevacizumab and followed up to 92 weeks. They were randomized into 2 arms. All patients received 3 loading doses 4 weeks apart and thereafter were assessed every 12 weeks until the end of the study. One arm received a routine treatment at each 12-week assessment, and the other arm was treated at these assessments on an as-needed basis. After the loading doses, patients in either arm who showed signs of disease activity had an additional assessment after 6 weeks and at that visit had top-up treatments on an as-needed basis. MAIN OUTCOME MEASURES: Mean best-corrected visual acuity (BCVA) at 92 weeks. RESULTS: At 92 weeks, patients who had treatments every 12 weeks had superior BCVA to those treated on an as-needed basis every 12 weeks (P = 0.008), with the regular treatment arm gaining a mean BCVA of 5.5 letters and the as-needed treatment arm gaining 0.6 letters. The regular treatment arm of the study showed significantly improved outcomes with respect to 5-, 10-, and 15-letter changes in BCVA from baseline compared with the as-needed treatment arm, as well as superior reading speed. In patients who completed the study, up to but not including week 92, the mean number of treatments was 10.8 for the regular treatment arm and 9.1 for the as-needed treatment arm. CONCLUSIONS: A treatment regimen with regular bevacizumab injections every 12 weeks after loading doses supplemented with as-needed top-up treatments produced a stable improvement in BCVA from baseline. The improvement in BCVA was broadly similar to that obtained in other studies using anti-vascular endothelial growth factor drugs with more frequent assessments and treatments.
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Inibidores da Angiogênese/administração & dosagem , Anticorpos Monoclonais Humanizados/administração & dosagem , Degeneração Macular Exsudativa/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Inibidores da Angiogênese/efeitos adversos , Anticorpos Monoclonais Humanizados/efeitos adversos , Bevacizumab , Feminino , Angiofluoresceinografia , Seguimentos , Humanos , Injeções Intravítreas , Masculino , Tomografia de Coerência Óptica , Resultado do Tratamento , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Acuidade Visual/fisiologia , Degeneração Macular Exsudativa/diagnóstico , Degeneração Macular Exsudativa/fisiopatologiaRESUMO
PURPOSE: To describe the types and prevalence of long-term, established pseudophakic dysphotopsia in a typical population more than a year after cataract extraction. DESIGN: Cross-sectional observational study. METHODS: Fifty-five patients who had undergone cataract surgery more than a year before were administered a questionnaire that was based on photographic images of photic phenomena. RESULTS: Dysphotopsia were found in 18 of 55 patients. There was a predominance of halos and starburst effects but also substantial symptoms of arc effect, streams of light, and central flash. There was no correlation between measured dysphotopsia and age, final attained acuity, or contrast sensitivity. CONCLUSIONS: Dysphotopsia in the operated eye was still a common symptom in its many forms more than a year after uncomplicated cataract surgery. There was no correlation of symptoms with age or visual function.
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Pseudofacia/fisiopatologia , Visão Intraocular/fisiologia , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Humanos , Implante de Lente Intraocular , Pessoa de Meia-Idade , Facoemulsificação , Prevalência , Inquéritos e Questionários , Acuidade VisualRESUMO
Disability glare describes the loss of retinal image contrast as a result of intraocular light scatter, or straylight. It has increasingly important modern implications such as with cataract and refractive surgery or high-intensity lighting. However, its measurement has proven difficult despite many varying approaches. This article aims to explain the principles and problems associated with glare testing that are important for assessment and use of glare measures. After defining disability glare, this article discusses the importance of its measurement to current clinical practice. It explains the principles and mechanisms that underlie disability glare and its measurement. Finally, some examples of available glare tests are described to illustrate the principles discussed.
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Sensibilidades de Contraste , Avaliação da Deficiência , Ofuscação , Transtornos da Visão/diagnóstico , Testes Visuais/métodos , Humanos , Luz , Testes Visuais/instrumentaçãoRESUMO
UNLABELLED: We performed a prospective, randomized trial assessing the "remaining" volume of anesthetic solution that stays within the sub-Tenon's space after administration of 2 different volumes: 3 mL and 5 mL. The remaining volume correlated with motor block (r = 0.72; P < 0.001). The volume lost through the incision as a percentage of total volume injected was similar in both groups, suggesting sub-Tenon's space is not limited to a finite injected volume less than 5 mL and may be capable of receiving larger volumes of anesthetic to improve motor block. IMPLICATIONS: The volume of anesthetic solution remaining within sub-Tenon's space correlates with motor block. The amount of volume lost as a percentage of total administered is independent of the volume injected, suggesting sub-Tenon's space is not limited to a finite injected volume less than 5 mL and may be capable of receiving larger volumes of anesthetic to improve motor block.
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Anestesia Local/métodos , Extração de Catarata/métodos , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos ProspectivosRESUMO
Measurements in ophthalmic research may be of parameters such as visual functions, quality of life or physical measures and can involve different types of instruments such as questionnaires and mechanical, chemical or electronic devices. Whatever the mode of measurement, however, all these devices require sufficient evidence for validity before inferences can be made on the basis of their findings. This article explores the nature and often overlooked importance of validity and explains some of the terminology involved. It discusses the main forms that ophthalmologists should be aware of before they can assess whether the instruments, old and new, are providing results upon which inferences can be made with any level of confidence. The literature search involved use of Medline, PubMed and Ovid as well as referenced papers in journals and books. Searches were comprehensive and international. Foreign texts were translated.
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Coleta de Dados/normas , Métodos Epidemiológicos , Oftalmologia , Humanos , Qualidade de Vida , Reprodutibilidade dos Testes , Inquéritos e Questionários , Acuidade VisualRESUMO
PURPOSE: To compare the effect of volume used in sub-Tenon's anaesthesia on efficacy and intraocular pressure (IOP). METHODS: A prospective, randomised clinical trial was conducted on 52 eyes of 52 consecutive patients undergoing sub-Tenon's anaesthetic for cataract surgery. Eyes were randomly assigned to either 3 mL or 5 mL volume of anaesthetic solution (0.5% bupivacaine/2% lidocaine in a 50:50 mixture). The main outcome measures were akinesia 5 min post-administration of anaesthetic, changes in IOP immediately after and 5 min after anaesthetic administration, and patient pain perception during procedure. RESULTS: The level of kinesia was greater in the 3 mL group (n = 25) compared to the 5 mL group (n = 27) (P = 0.001, Mann-;Whitney U-test). There was no significant difference in pain perception between the two groups (P = 0.464, student t-test). Although there was great variation in IOP changes following sub-Tenon's anaesthetic, there was a trend for a larger rise in mean IOP immediately after anaesthetic administration in the 5 mL group (mean +/- SD +5.6 +/- 4.2 mmHg) compared to the 3 mL group (+4.3 +/- 3.8 mmHg), but this did not reach statistical significance (P = 0.25, student t-test). CONCLUSIONS: A 5 mL volume of anaesthetic provides akinesia superior to a 3 mL volume in sub-Tenon's anaesthesia for cataract surgery.
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Anestesia Local/métodos , Anestésicos Combinados/administração & dosagem , Anestésicos Locais/administração & dosagem , Bupivacaína/administração & dosagem , Pressão Intraocular/efeitos dos fármacos , Lidocaína/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Analgesia , Extração de Catarata , Tecido Conjuntivo/efeitos dos fármacos , Feminino , Humanos , Injeções , Masculino , Pessoa de Meia-Idade , Bloqueio Nervoso , Medição da Dor , Dor Pós-Operatória , Estudos ProspectivosRESUMO
BACKGROUND: This paper attempts to clarify the usefulness of various simple pre-operative measures in estimating the potential for a visually successful capsulotomy. METHODS: 24 patients attending for capsulotomy had pre-operative measures of glare with BAT tester, visibility of posterior pole and grading of posterior capsular pearls and fibrosis seen at slit lamp. Visual function was measured before and after standardised capsulotomy. Correlations of the various preoperative measures with eventual visual function improvements were calculated. RESULTS: Pearls at slit lamp and poor posterior pole visualisation were all correlated with improvements in visual acuity and contrast sensitivity after capsulotomy. Amount of fibrosis visible at slit lamp and glare assessment were not correlated with vision improvements after laser. CONCLUSION: Of the various measures that are taken prior to Nd : YAG capsulotomy, some correlate with eventual visual improvement but for others no clinical utility was found. Practitioners should note these findings as they are especially of use in more questionable or high-risk cases to help determine whether referral for PCO treatment by Nd: YAG capsulotomy is likely to benefit the patient.
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Catarata/diagnóstico , Técnicas de Diagnóstico Oftalmológico , Terapia a Laser , Cápsula do Cristalino/patologia , Complicações Pós-Operatórias/diagnóstico , Acuidade Visual/fisiologia , Idoso , Idoso de 80 Anos ou mais , Extração de Catarata , Feminino , Ofuscação , Humanos , Cápsula do Cristalino/cirurgia , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/cirurgia , Cuidados Pré-OperatóriosRESUMO
BACKGROUND: To evaluate the effect of Nd:YAG capsulotomy for posterior capsular opacification (PCO) on visualisation of the peripheral fundus with scleral indentation. METHODS: Patients undergoing Nd:YAG capsulotomy for PCO were examined pre- and four weeks post- Nd:YAG capsulotomy. In order to give a quantitative measure of visualisation of the peripheral retina, a novel scalar measurement was developed. Changes in the degree of visualisation following Nd:YAG capsulotomy were calculated. RESULTS: There was a significant improvement in fundal visualisation of the retinal periphery with scleral indentation following Nd:YAG capsulotomy (p = 0.001). CONCLUSION: Peripheral fundal visualisation with scleral indentation improves following a small central Nd:YAG capsulotomy. This finding is important in relation to the detection of peripheral pseudophakic retinal breaks, particularly in those patients deemed at high risk following Nd:YAG capsulotomy.
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Fundo de Olho , Terapia a Laser , Cápsula do Cristalino/cirurgia , Complicações Pós-Operatórias/cirurgia , Perfurações Retinianas/diagnóstico , Idoso , Idoso de 80 Anos ou mais , Catarata/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Oftalmologia/métodos , Estudos Prospectivos , Pseudofacia/cirurgia , Esclera/fisiopatologiaRESUMO
BACKGROUND: To report the clinicopathologic features of a fibrocellular membrane in a pseudophakic eye with retained silicone oil in the absence of any capsular contraction syndrome, necessitating repeat anterior capsulorhexis. METHODS: Clinicopathologic report of a case. RESULTS: Histopathologic study of the membrane showed absence of any true periodic acid Schiff-positive capsule within the specimen. Clinically, there was no evidence of any anterior capsular contraction. The fibrocellular membrane may have occurred as a result of inflammatory and mechanical effects of silicone oil in the anterior chamber or as a result of the intraocular lens design. CONCLUSION: The authors report the clinicopathologic features of a fibrocellular membrane occluding the anterior capsular opening in a pseudophakic eye with retained silicone oil, in the absence of any capsular contraction. The stimulus for its formation may have been the inflammatory and mechanical effects of retained silicone oil in the anterior chamber.
Assuntos
Catarata/induzido quimicamente , Cápsula do Cristalino/efeitos dos fármacos , Complicações Pós-Operatórias , Pseudofacia/complicações , Óleos de Silicone/efeitos adversos , Adulto , Capsulorrexe , Catarata/patologia , Fibrose , Humanos , Cápsula do Cristalino/patologia , Lentes Intraoculares , Masculino , Membranas , ReoperaçãoAssuntos
Terapia a Laser/efeitos adversos , Cápsula do Cristalino/cirurgia , Facoemulsificação , Complicações Pós-Operatórias/cirurgia , Pseudofacia/etiologia , Descolamento Retiniano/etiologia , Humanos , Cápsula do Cristalino/patologia , Implante de Lente Intraocular , Miopia/complicações , Fatores de RiscoRESUMO
Surgery for cataract removal has become successively refined such that posterior capsular opacification is the most common problem presenting after modern cataract extraction. Various techniques and treatments exist to manage patients with posterior capsular opacification using Nd:YAG capsulotomy. There are many possible variations in initial assessment, pre-laser treatments, laser techniques, and follow-up routines. The literature on the use of Nd:YAG laser for capsulotomy was reviewed and interpreted. This article presents the currently available knowledge in a format that allows the practitioner to tailor an evidence-based protocol for treating patients with symptomatic posterior capsule opacification.