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1.
Graefes Arch Clin Exp Ophthalmol ; 262(4): 1141-1149, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38038728

RESUMO

PURPOSE: To propose a minimum specification dataset to characterize liquid ocular endotamponades (OEs), namely silicone oil (SO), heavy SO (HSO), perfluorodecalin (PFD), and perfluoro-octane (PFO), in terms of physicochemical properties, purity and available evidence of safety, in line with ISO16672:2020. METHODS: An evidence-based consensus using the expert panel technique was conducted. Two facilitators led a committee of 11 European experts. Facilitators prepared a dataset for each compound including the list of specifications relevant for the safety, identified by the group members on the basis of expertise and a comprehensive literature review. Each item was ranked by each member using a 9-point scale from 1 "absolutely to not include" to 9 "absolutely to include" in two rounds followed by discussion. Only items reaching consensus (score ≥ 7 from ≥ 75% of members) were included in the final datasets. RESULTS: For all OEs, consensus was reached to include manufacturer, density, refractive index, chemical composition, dynamic viscosity, interfacial and surface tension, endotoxins, in vitro cytotoxicity assessment, and any evidence from ex vivo and/or in vivo tests for safety assessment. Additional specifications were added for SO (molecular weight distribution, content of oligosiloxanes with MW ≤ 1000 g/mol, spectral transmittance) and PFD/PFO (% of pure PFD/PFO in the final product, vapor pressure, chemical analyses performed for safety assessment). CONCLUSION: The proposed evidence-based minimum specification datasets for SO, HSO, PFD, and PFO have the potential to provide surgeons and health service purchasers with an easily available overview of the most relevant information for the safety assessment of OEs.


Assuntos
Olho , Fluorocarbonos , Humanos , Tamponamento Interno
2.
Cochrane Database Syst Rev ; 5: CD008214, 2023 05 31.
Artigo em Inglês | MEDLINE | ID: mdl-37260074

RESUMO

BACKGROUND: Vitrectomy is an established treatment for the complications of proliferative diabetic retinopathy (PDR). However, a number of complications can occur during and after vitrectomy for PDR. These include bleeding and the creation of retinal holes during surgery, and bleeding, retinal detachment and scar tissue on the retina after surgery. These complications can limit vision, require further surgery and delay recovery. The use of anti-vascular endothelial growth factor (anti-VEGF) agents injected into the eye before surgery has been proposed to reduce the occurrence of these complications. Anti-VEGF agents can reduce the amount and vascularity of abnormal new vessels associated with PDR, facilitating their dissection during surgery, reducing intra- and postoperative bleeding, and potentially improving outcomes. OBJECTIVES: To assess the effects of perioperative anti-VEGF use on the outcomes of vitrectomy for the treatment of complications for proliferative diabetic retinopathy (PDR). SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; which contains the Cochrane Eyes and Vision Trials Register; 2022, Issue 6); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov and the WHO ICTRP. The date of the search was 22 June 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that looked at the use of anti-VEGFs and the incidence of complications in people undergoing vitrectomy for PDR.   DATA COLLECTION AND ANALYSIS: Two review authors independently assessed and extracted the data. We used the standard methodological procedures expected by Cochrane. The critical outcomes of the review were the mean difference in best corrected visual acuity (BCVA) between study arms at six (± three) months after the primary vitrectomy, the incidence of early postoperative vitreous cavity haemorrhage (POVCH, within four weeks postoperatively), the incidence of late POVCH (occurring more than four weeks postoperatively), the incidence of revision surgery for POVCH within six months, the incidence of revision surgery for recurrent traction/macular pucker of any type and/or rhegmatogenous retinal detachment within six months and vision-related quality of life (VRQOL) measures. Important outcomes included the proportion of people with a visual acuity of counting fingers (1.8 logMAR or worse), the number of operative retinal breaks reported and the frequency of silicone oil tamponade required at time of surgery. MAIN RESULTS: The current review includes 28 RCTs that looked at the pre- or intraoperative use of intravitreal anti-VEGFs to improve the outcomes of pars plana vitrectomy for complications of PDR. The studies were conducted in a variety of countries (11 from China, three from Iran, two from Italy, two from Mexico and the remaining studies from South Korea, the UK, Egypt, Brazil, Japan, Canada, the USA, Indonesia and Pakistan). The inclusion criteria for entry into the studies were the well-recognised complications of proliferative retinopathy: non-clearing vitreous haemorrhage, tractional retinal detachment involving the macula or combined tractional rhegmatogenous detachment. The included studies randomised a total of 1914 eyes.  We identified methodological issues in all of the included studies. Risk of bias was highest for masking of participants and investigators, and a number of studies were unclear when describing randomisation methods and sequence allocation. Participants receiving intravitreal anti-VEGF in addition to pars plana vitrectomy achieved better BCVA at six months compared to people undergoing vitrectomy alone (mean difference (MD) -0.25 logMAR, 95% confidence interval (CI) -0.39 to -0.11; 13 studies, 699 eyes; low-certainty evidence). Pre- or intraoperative anti-VEGF reduced the incidence of early POVCH (12% versus 31%, risk ratio (RR) 0.44, 95% CI 0.34 to 0.58; 14 studies, 1038 eyes; moderate-certainty evidence). Perioperative anti-VEGF use was also associated with a reduction in the incidence of late POVCH (10% versus 23%, RR 0.47, 95% CI 0.30 to 0.74; 11 studies, 579 eyes; high-certainty evidence). The need for revision surgery for POVCH occurred less frequently in the anti-VEGF group compared with control, but the confidence intervals were wide and compatible with no effect (4% versus 13%, RR 0.44, 95% CI 0.15 to 1.28; 4 studies 207 eyes; moderate-certainty evidence). Similar imprecisely measured effects were seen for revision surgery for rhegmatogenous retinal detachment (5% versus 11%, RR 0.50, 95% CI 0.15 to 1.66; 4 studies, 145 eyes; low-certainty evidence).  Anti-VEGFs reduce the incidence of intraoperative retinal breaks (12% versus 31%, RR 0.37, 95% CI 0.24 to 0.59; 12 studies, 915 eyes; high-certainty evidence) and the need for silicone oil (19% versus 41%, RR 0.46, 95% CI 0.27 to 0.80; 10 studies, 591 eyes; very low-certainty evidence). No data were available on quality of life outcomes or the proportion of participants with visual acuity of counting fingers or worse. AUTHORS' CONCLUSIONS: The perioperative use of anti-VEGF reduces the risk of late POVCH, probably results in lower early POVCH risk and may improve visual outcomes. It also reduces the incidence of intraoperative retinal breaks. The evidence is very uncertain about its effect on the need for silicone oil tamponade. The reported complications from its use appear to be low. Agreement on variables included and outcome standardisation is required in trials studying vitrectomy for PDR.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Descolamento Retiniano , Perfurações Retinianas , Humanos , Retinopatia Diabética/cirurgia , Retinopatia Diabética/complicações , Fatores de Crescimento Endotelial , Hemorragia Pós-Operatória/cirurgia , Descolamento Retiniano/etiologia , Descolamento Retiniano/cirurgia , Perfurações Retinianas/complicações , Óleos de Silicone , Vitrectomia/efeitos adversos
3.
Cochrane Database Syst Rev ; 6: CD009300, 2023 06 14.
Artigo em Inglês | MEDLINE | ID: mdl-37314061

RESUMO

BACKGROUND: Age-related macular degeneration (AMD) is a common eye disease and leading cause of sight loss worldwide. Despite its high prevalence and increasing incidence as populations age, AMD remains incurable and there are no treatments for most patients. Mounting genetic and molecular evidence implicates complement system overactivity as a key driver of AMD development and progression. The last decade has seen the development of several novel therapeutics targeting complement in the eye for the treatment of AMD. This review update encompasses the results of the first randomised controlled trials in this field. OBJECTIVES: To assess the effects and safety of complement inhibitors in the prevention or treatment of AMD. SEARCH METHODS: We searched CENTRAL on the Cochrane Library, MEDLINE, Embase, LILACS, Web of Science, ISRCTN registry, ClinicalTrials.gov, and the WHO ICTRP to 29 June 2022 with no language restrictions. We also contacted companies running clinical trials for unpublished data. SELECTION CRITERIA: We included randomised controlled trials (RCTs) with parallel groups and comparator arms that studied complement inhibition for advanced AMD prevention/treatment. DATA COLLECTION AND ANALYSIS: Two authors independently assessed search results and resolved discrepancies through discussion. Outcome measures evaluated at one year included change in best-corrected visual acuity (BCVA), untransformed and square root-transformed geographic atrophy (GA) lesion size progression, development of macular neovascularisation (MNV) or exudative AMD, development of endophthalmitis, loss of ≥ 15 letters of BCVA, change in low luminance visual acuity, and change in quality of life. We assessed risk of bias and evidence certainty using Cochrane risk of bias and GRADE tools. MAIN RESULTS: Ten RCTs with 4052 participants and eyes with GA were included. Nine evaluated intravitreal (IVT) administrations against sham, and one investigated an intravenous agent against placebo. Seven studies excluded patients with prior MNV in the non-study eye, whereas the three pegcetacoplan studies did not. The risk of bias in the included studies was low overall. We also synthesised results of two intravitreal agents (lampalizumab, pegcetacoplan) at monthly and every-other-month (EOM) dosing intervals. Efficacy and safety of IVT lampalizumab versus sham for GA For 1932 participants in three studies, lampalizumab did not meaningfully change BCVA given monthly (+1.03 letters, 95% confidence interval (CI) -0.19 to 2.25) or EOM (+0.22 letters, 95% CI -1.00 to 1.44) (high-certainty evidence). For 1920 participants, lampalizumab did not meaningfully change GA lesion growth given monthly (+0.07 mm², 95% CI -0.09 to 0.23; moderate-certainty due to imprecision) or EOM (+0.07 mm², 95% CI -0.05 to 0.19; high-certainty). For 2000 participants, lampalizumab may have also increased MNV risk given monthly (RR 1.77, 95% CI 0.73 to 4.30) and EOM (RR 1.70, 95% CI 0.67 to 4.28), based on low-certainty evidence. The incidence of endophthalmitis in patients treated with monthly and EOM lampalizumab was 4 per 1000 (0 to 87) and 3 per 1000 (0 to 62), respectively, based on moderate-certainty evidence. Efficacy and safety of IVT pegcetacoplan versus sham for GA For 242 participants in one study, pegcetacoplan probably did not meaningfully change BCVA given monthly (+1.05 letters, 95% CI -2.71 to 4.81) or EOM (-1.42 letters, 95% CI -5.25 to 2.41), as supported by moderate-certainty evidence. In contrast, for 1208 participants across three studies, pegcetacoplan meaningfully reduced GA lesion growth when given monthly (-0.38 mm², 95% CI -0.57 to -0.19) and EOM (-0.29 mm², 95% CI -0.44 to -0.13), with high certainty. These reductions correspond to 19.2% and 14.8% versus sham, respectively. A post hoc analysis showed possibly greater benefits in 446 participants with extrafoveal GA given monthly (-0.67 mm², 95% CI -0.98 to -0.36) and EOM (-0.60 mm², 95% CI -0.91 to -0.30), representing 26.1% and 23.3% reductions, respectively. However, we did not have data on subfoveal GA growth to undertake a formal subgroup analysis. In 1502 participants, there is low-certainty evidence that pegcetacoplan may have increased MNV risk when given monthly (RR 4.47, 95% CI 0.41 to 48.98) or EOM (RR 2.29, 95% CI 0.46 to 11.35). The incidence of endophthalmitis in patients treated with monthly and EOM pegcetacoplan was 6 per 1000 (1 to 53) and 8 per 1000 (1 to 70) respectively, based on moderate-certainty evidence. Efficacy and safety of IVT avacincaptad pegol versus sham for GA In a study of 260 participants with extrafoveal or juxtafoveal GA, monthly avacincaptad pegol probably did not result in a clinically meaningful change in BCVA at 2 mg (+1.39 letters, 95% CI -5.89 to 8.67) or 4 mg (-0.28 letters, 95% CI -8.74 to 8.18), based on moderate-certainty evidence. Despite this, the drug was still found to have probably reduced GA lesion growth, with estimates of 30.5% reduction at 2 mg (-0.70 mm², 95% CI -1.99 to 0.59) and 25.6% reduction at 4 mg (-0.71 mm², 95% CI -1.92 to 0.51), based on moderate-certainty evidence. Avacincaptad pegol may have also increased the risk of developing MNV (RR 3.13, 95% CI 0.93 to 10.55), although this evidence is of low certainty. There were no cases of endophthalmitis reported in this study. AUTHORS' CONCLUSIONS: Despite confirmation of the negative findings of intravitreal lampalizumab across all endpoints, local complement inhibition with intravitreal pegcetacoplan meaningfully reduces GA lesion growth relative to sham at one year. Inhibition of complement C5 with intravitreal avacincaptad pegol is also an emerging therapy with probable benefits on anatomical endpoints in the extrafoveal or juxtafoveal GA population. However, there is currently no evidence that complement inhibition with any agent improves functional endpoints in advanced AMD; further results from the phase 3 studies of pegcetacoplan and avacincaptad pegol are eagerly awaited. Progression to MNV or exudative AMD is a possible emergent adverse event of complement inhibition, requiring careful consideration should these agents be used clinically. Intravitreal administration of complement inhibitors is probably associated with a small risk of endophthalmitis, which may be higher than that of other intravitreal therapies. Further research is likely to have an important impact on our confidence in the estimates of adverse effects and may change these. The optimal dosing regimens, treatment duration, and cost-effectiveness of such therapies are yet to be established.


Assuntos
Endoftalmite , Atrofia Geográfica , Degeneração Macular , Humanos , Administração Intravenosa , Inativadores do Complemento/efeitos adversos , Atrofia Geográfica/tratamento farmacológico , Degeneração Macular/tratamento farmacológico
4.
Cochrane Database Syst Rev ; 11: CD013678, 2021 11 08.
Artigo em Inglês | MEDLINE | ID: mdl-34748208

RESUMO

BACKGROUND: Lamellar macular holes (LMHs) are small, partial-thickness defects of the macula defined by characteristic features on optical coherence tomography (OCT), including a newly recognised type of epiretinal membrane termed 'epiretinal proliferation'. There may be a rationale to recommend surgery for individuals with LMHs, particularly those with functional or anatomical deterioration, or poor baseline vision causing significant disability, to stabilise the LMH and prevent further visual deterioration; however, there is currently no evidence-based consensus. OBJECTIVES: To assess the effect of surgical interventions on post-operative visual and anatomical outcomes in people with a confirmed LMH. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE Ovid, Embase Ovid, Scopus SciVerse, ISRCTN registry, US National Institutes of Health Ongoing Trials Register, ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We also searched reference lists of included trials to identify other eligible trials which our search strategy may have missed. The date of the search was 20 July 2021. SELECTION CRITERIA: We included randomised controlled trials (RCTs) involving participants with a confirmed LMH diagnosis which reported one or more surgical intervention(s), alone or in combination, in at least one arm of the RCT. DATA COLLECTION AND ANALYSIS: We used standard methods as expected by Cochrane. Two study authors independently extracted data and assessed the risk of bias for included trials. Trial authors were contacted for further information and clarification. MAIN RESULTS: A single RCT was eligible for inclusion. Thirty-six participants were randomised in a 2:1 ratio; 24 were allocated to undergo surgery (pars plana vitrectomy, peeling of the epiretial proliferation followed by fovea-sparing removal of the internal limiting membrane) and 12 (10 following two participant dropouts) to observation. Overall, the certainty of the evidence was low for all outcomes due to selection and detection bias, and the low number of participants enrolled in the study which may affect the accuracy of results and reliability of conclusions. At six-month follow-up, change in vision was better in the surgery group (-0.27 logMAR improvement) than observation (0.02 worsening) (mean difference (MD): -0.29 logMAR, 95% confidence intervals (CI): -0.33 to -0.25). Central retinal thickness increased in the surgery group over 6 months 126 µm increase) compared with observation group (decrease by 11µm) (MD: 137 µm, 95% CI: 125.87 µm to 148.13 µm). Finally, at six-month follow-up, retinal sensitivity was better in the surgery group (3.03 dB increase) compared with the observation group (0.06 dB decrease) (MD: 3.09 dB, 95% CI: 2.07 to 4.11 dB). Vision-related quality of life and metamorphopsia were not reported. No adverse outcomes or complications were reported in the study, however, authors could not provide information on whether any individuals developed deterioration in vision of 0.2 logMAR or worse. AUTHORS' CONCLUSIONS: The included single trial demonstrated improvements in visual and anatomical outcome measures for participants with a LMH who underwent surgery compared with observation only. Therefore, we can conclude that participants who undergo surgery may achieve superior post-operative best corrected visual acuity and anatomical outcomes compared with observation only. However, the results of a single and small RCT provides limited evidence to support or refute surgery as an effective management option for LMHs. Future RCTs with a larger number of participants and with fewer methodological limitations and biases are necessary to inform future clinical practice.


Assuntos
Macula Lutea , Perfurações Retinianas , Humanos , Macula Lutea/diagnóstico por imagem , Macula Lutea/cirurgia , Ensaios Clínicos Controlados Aleatórios como Assunto , Retina , Perfurações Retinianas/cirurgia , Acuidade Visual , Vitrectomia
5.
Cochrane Database Syst Rev ; 5: CD013029, 2021 05 06.
Artigo em Inglês | MEDLINE | ID: mdl-34097768

RESUMO

BACKGROUND: Age-related macular degeneration (AMD) is one of the leading causes of blindness in high-income countries. The majority of cases of AMD are of the non-exudative type. Experts have proposed photobiomodulation (PBM) therapy as a non-invasive procedure to restore mitochondrial function, upregulate cytoprotective factors and prevent apoptotic cell death in retinal tissue affected by AMD. OBJECTIVES: To assess the effectiveness and safety of PBM compared to standard care, no treatment or sham treatment for people with non-exudative AMD. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (Issue 5, 2020), Ovid MEDLINE, Embase, ISRCTN, ClinicalTrials.gov and the WHO ICTRP to 11 May 2020 with no language restrictions. SELECTION CRITERIA: The review included randomised controlled trials (RCTs) on participants receiving any type of PBM therapy for non-exudative AMD compared to standard care, sham treatment or no treatment. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. We considered the following outcome measures at 12 months: best-corrected visual acuity (BCVA) ; contrast sensitivity; near vision; low luminance density score; reading speed; vision-related quality of life score; and adverse events such as progression of AMD and conversion to exudative AMD. We graded the certainty of the evidence using GRADE. MAIN RESULTS: We included two published RCTs from single centres in the UK and Canada, which recruited 60 participants (60 eyes) and 30 participants (46 eyes) respectively. Participants in these trials were people with non-exudative AMD with Age-Related Eye Disease Study (AREDS) categories 2 to 4. One study compared single wavelength PBM with no treatment. This study was at risk of performance bias because the study was not masked, and there was attrition bias. One study compared multi-wavelength PBM with sham treatment and conflicts of interest were reported by study investigators. We also identified three eligible ongoing RCTs from searching the clinical trials database. When comparing PBM with sham treatment or no treatment for non-exudative AMD, there was no evidence of any meaningful clinical difference in BCVA at 12 months (mean difference (MD) 0.02 logMAR, 95% confidence interval (CI) -0.02 to 0.05; 2 RCTs, 90 eyes; low-certainty evidence). One study comparing multi-wavelength PBM with sham treatment showed an improvement in contrast sensitivity at Level E (18 cycles/degree) at 12 months (MD 0.29 LogCS, 95% CI 0.23 to 0.35; 1 RCT, 46 eyes; low-certainty evidence). Visual function and health-related quality of life scores were comparable between single wavelength PBM and no treatment groups at 12 months (VFQ-48 score MD 0.43, 95% CI -0.17 to 1.03; P = 0.16; 1 RCT, 47 eyes; low-certainty evidence). When comparing PBM with sham treatment or no treatment for non-exudative AMD, there was no evidence of any meaningful clinical difference in conversion to exudative AMD (risk ratio (RR) 0.97, 95% CI 0.17 to 5.44; 2 RCTs, 96 eyes; very low-certainty evidence) at 12 months. There was inconclusive evidence that single wavelength PBM prevents the progression of AMD (RR 0.79, 95% CI 0.41 to 1.53; P = 0.48; 1 RCT, 50 eyes; low-certainty evidence). Disease progression was defined as the development of advanced AMD or significant increase in drusen volume. No included study reported near vision, low luminance vision or reading speed outcomes. AUTHORS' CONCLUSIONS: Currently there remains uncertainty whether PBM treatment is beneficial in slowing progression of non-exudative macular degeneration. There is a need for further well-designed controlled trials assessing dosimetry, powered for both effectiveness and safety outcomes. Consideration should be given to the adoption of agreed clinical outcome measures and patient-based outcome measures for AMD.


ANTECEDENTES: La degeneración macular senil (DMS) es una de las principales causas de ceguera en los países de ingresos altos. La mayoría de los casos de DMS son de tipo no exudativo. Los expertos han propuesto el tratamiento con fotobiomodulación (PBM por sus siglas en inglés) como procedimiento no invasivo para restaurar la función mitocondrial, aumentar los factores citoprotectores y prevenir la muerte celular apoptótica en el tejido retiniano afectado por la DMS. OBJETIVOS: Evaluar la eficacia y la seguridad de la PBM en comparación con la atención estándar, ningún tratamiento o el tratamiento simulado en personas con DMS no exudativa. MÉTODOS DE BÚSQUEDA: Se realizaron búsquedas en CENTRAL (que contiene el Registro de ensayos del Grupo Cochrane de Salud ocular y de la visión [Cochrane Eyes and Vision]) (número 5, 2020), Ovid MEDLINE, Embase, ISRCTN, ClinicalTrials.gov y la ICTRP de la OMS hasta el 11 de mayo de 2020 sin restricciones de idioma. CRITERIOS DE SELECCIÓN: La revisión incluyó ensayos controlados aleatorizados (ECA) sobre participantes que recibían cualquier tipo de tratamiento con PBM para la DMS no exudativa en comparación con atención estándar, tratamiento simulado o ningún tratamiento. OBTENCIÓN Y ANÁLISIS DE LOS DATOS: Se utilizaron los procedimientos metodológicos estándar previstos por Cochrane. Se consideraron las siguientes medidas de desenlace a los 12 meses: agudeza visual mejor corregida (AVMC); sensibilidad al contraste; visión de cerca; puntuación de la densidad de baja luminancia; velocidad de lectura; puntuación de la calidad de vida relacionada con la visión; y eventos adversos como la progresión de la DMS y la conversión a DMS exudativa. La certeza de la evidencia se evaluó mediante el método GRADE. RESULTADOS PRINCIPALES: Se incluyeron dos ECA publicados de centros únicos en el Reino Unido y Canadá, que reclutaron 60 participantes (60 ojos) y 30 participantes (46 ojos) respectivamente. Los participantes en estos ensayos eran personas con DMS no exudativa con categorías 2 a 4 del Age­Related Eye Disease Study (AREDS). Un estudio comparó la PBM de longitud de onda única con ningún tratamiento. Este estudio tenía riesgo de sesgo de realización porque el estudio no estaba enmascarado y había sesgo de desgaste. Un estudio comparó la PBM de longitud de onda múltiple con tratamiento simulado y los investigadores del estudio informaron conflictos de intereses. A partir de la búsqueda en la base de datos de ensayos clínicos también se identificaron tres ECA elegibles en curso. Cuando se comparó la PBM con el tratamiento simulado o ningún tratamiento para la DMS no exudativa, no hubo evidencia de una diferencia clínica significativa en la AVMC a los 12 meses (diferencia de medias [DM] 0,02 logMAR; intervalo de confianza [IC] del 95%: ­0,02 a 0,05; dos ECA, 90 ojos; evidencia de certeza baja). Un estudio que comparó la PBM de longitud de onda múltiple con el tratamiento simulado mostró una mejoría en la sensibilidad al contraste en el nivel E (18 ciclos/grado) a los 12 meses (DM 0,29 LogCS; IC del 95%: 0,23 a 0,35; un ECA, 46 ojos; evidencia de certeza baja). Las puntuaciones de la función visual y de la calidad de vida relacionada con la salud fueron comparables entre los grupos de PBM de longitud de onda única y ningún tratamiento a los 12 meses (puntuación VFQ­48 DM 0,43; IC del 95%: ­0,17 a 1,03; p = 0,16; un ECA, 47 ojos; evidencia de certeza baja). Cuando se comparó la PBM con el tratamiento simulado o ningún tratamiento para la DMS no exudativa, no hubo evidencia de una diferencia clínica significativa en la conversión a DMS exudativa (razón de riesgos [RR] 0,97; IC del 95%: 0,17 a 5,44; dos ECA, 96 ojos; evidencia de certeza muy baja) a los 12 meses. No hubo evidencia concluyente de que la PBM de longitud de onda única prevenga la progresión de la DMS (RR 0,79; IC del 95%: 0,41 a 1,53; p = 0,48; un ECA, 50 ojos; evidencia de certeza baja). La progresión de la enfermedad se definió como el desarrollo de DMS avanzada o el aumento significativo del volumen de drusas. Ningún estudio incluido informó sobre los desenlaces de la visión de cerca, la visión de baja luminancia o la velocidad de lectura. CONCLUSIONES DE LOS AUTORES: En la actualidad no se sabe si el tratamiento con PBM es beneficioso para frenar la progresión de la degeneración macular no exudativa. Se necesitan más ensayos controlados y bien diseñados que evalúen la dosimetría y con poder estadístico para evaluar los desenlaces de eficacia y seguridad. Se debe considerar la adopción de medidas de desenlace clínicas acordadas y medidas de desenlace basadas en el paciente para la DMS.


Assuntos
Terapia com Luz de Baixa Intensidade/métodos , Degeneração Macular/radioterapia , Viés , Intervalos de Confiança , Sensibilidades de Contraste , Progressão da Doença , Humanos , Terapia com Luz de Baixa Intensidade/efeitos adversos , Avaliação de Resultados em Cuidados de Saúde , Placebos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Acuidade Visual
6.
Clin Ophthalmol ; 11: 1365-1370, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28794614

RESUMO

PURPOSE: To assess the accuracy of B-scan ultrasound (U/S) in diagnosing cases of acute fundus obscuring vitreous hemorrhage (FOVH) using a standardized scan protocol and dedicated ophthalmic ultrasonographer. METHODS: Consecutive patients presenting with acute FOVH of unknown cause, between January 2013 and December 2014, were prospectively recruited. Patients underwent a scan performed by a dedicated ultrasonographer, utilizing a systematic scan sequence and using an ocular specific U/S device. The U/S findings were compared to the findings during vitrectomy or after spontaneous hemorrhage clearance. RESULTS: Fifty-eight eyes (58 patients) were included. An underlying rhegmatogenous retinal detachment (RRD) and retinal tears without RRD were reported in nine and 14 patients, respectively. Nineteen of these patients underwent vitrectomy, and the other four underwent laser retinopexy or cryopexy alone. An additional six patients with suspected but uncertain retinal tears underwent vitrectomy, during which tears were confirmed in three, two had retinal vessel avulsions, and one had retinal new vessels. There was "complete" agreement between the B-scan findings and clinical findings in 78% of patients, "partial" agreement in 19%, and agreement was not tested in 3%. When the agreement was "partial", the disagreements did not affect patient management. The sensitivity was 100% for the detection of RRD, and for the detection of new retinal tears in patients without retinal detachment. CONCLUSION: B-scan U/S scan was highly sensitive in identifying the pathology in acute FOVH. Our results show an improvement from previously reported results, likely related to the standardized scan protocol and dedicated ophthalmic ultrasonographer.

7.
Clin Ophthalmol ; 8: 1089-95, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24959066

RESUMO

PURPOSE: This study describes a novel subtype of retinal detachment occurring in eyes with pathological myopia associated with type 3 posterior staphyloma and discusses the management options. METHODS: We retrospectively reviewed the case notes of seven patients who presented with unilateral symptomatic rhegmatogenous retinal detachment secondary to nasal juxtapapillary microholes. RESULTS: All seven patients had pathological myopia and an associated peripapillary type 3 posterior staphyloma. They all presented with symptoms of acute posterior vitreous detachment and had progressive retinal detachment. All cases were discovered to have a single juxtapapillary hole less than 1 disc diameter from the optic-nerve head, within areas of nasal chorioretinal atrophy. The microholes were identified intraoperatively in six of seven cases, with one case identified preoperatively on optical coherence tomography. In the four most recent cases, successful retinal reattachment was achieved with vitrectomy and C2F6 gas tamponade. The remaining three cases were managed with vitrectomy and silicone oil. CONCLUSION: Seven patients with pathological myopia, type 3 posterior staphyloma, and progressive retinal detachment secondary to juxtapapillary microholes are presented in this paper. High clinical suspicion is required to identify these breaks. Successful retinal reattachment with pars plana vitrectomy and long-acting gas is possible.

8.
Cochrane Database Syst Rev ; (5): CD008214, 2011 May 11.
Artigo em Inglês | MEDLINE | ID: mdl-21563165

RESUMO

BACKGROUND: Postoperative vitreous cavity haemorrhage (POVCH) is a significant complication following vitrectomy for proliferative diabetic retinopathy (PDR). It delays visual recovery and can make further treatment difficult if the view of the fundus is significantly obscured. A number of interventions to reduce the incidence of POVCH have been proposed, including the perioperative use of anti-vascular endothelial growth factor (anti-VEGF). Anti-VEGFs reduce vascular proliferation and the vascularity of neovascular tissue, which is often the source of bleeding following vitrectomy. OBJECTIVES: The review aims to assess the effect of perioperative anti-VEGF in reducing the incidence of POVCH. SEARCH STRATEGY: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2011, Issue 2), MEDLINE (January 1950 to March 2011), PubMed (10 March 2011), EMBASE (January 1980 to March 2011), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to March 2011), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) and ClinicalTrials.gov (www.clinicaltrial.gov). There were no date or language restrictions in the electronic searches for trials. The electronic databases were last searched on 10 March 2011. SELECTION CRITERIA: We included all randomised controlled trials (RCTs) that looked at the use of anti-VEGFs and the incidence of POVCH in people undergoing vitrectomy for PDR. DATA COLLECTION AND ANALYSIS: Both review authors independently assessed and extracted the data using a standardised form based on the CONSORT statement. MAIN RESULTS: We included four studies (202 eyes of 198 participants) in this review. The four RCTs met the inclusion criteria, but we were unable to conduct a meta-analysis due to methodological issues in three of the trials. We have provided a summary of the effects of the interventions. We have also provided a summary of the current literature addressing each primary and secondary outcome. AUTHORS' CONCLUSIONS: Results from one of the included studies support the use of preoperative intravitreal bevacizumab to reduce the incidence of early POVCH. There are currently no other high quality RCTs that support the use of anti-VEGF agents perioperatively to reduce the incidence of early or late POVCH. The remaining studies identified by the search suggest that the preoperative use of bevacizumab may reduce the incidence of early POVCH, but it should be recognised that there are a number of significant methodological issues in these studies that lead us to be cautious when interpreting their findings and make any definitive conclusions unwarranted.


Assuntos
Retinopatia Diabética/cirurgia , Hemorragia Pós-Operatória/prevenção & controle , Fatores de Crescimento do Endotélio Vascular/antagonistas & inibidores , Vitrectomia/efeitos adversos , Hemorragia Vítrea/prevenção & controle , Inibidores da Angiogênese/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Anticorpos Monoclonais Humanizados , Bevacizumab , Humanos , Injeções Intravítreas , Ensaios Clínicos Controlados Aleatórios como Assunto , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores
9.
Clin Ophthalmol ; 5: 109-14, 2011 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-21339803

RESUMO

BACKGROUND: To assess the rate and type of retinal break formation in patients undergoing 23 gauge transconjunctival vitrectomy surgery for complications of proliferative diabetic retinopathy compared with 20 gauge vitrectomy surgery. METHODS: Retrospective case notes review of two consecutive series of patients who had primary pars plana vitrectomy for complications of proliferative diabetic retinopathy by a single surgeon. The control group had standard 20 gauge vitrectomy surgery whilst the second group had 23 gauge transconjunctival vitrectomy surgery. RESULTS: Eighty-five eyes were included in the 20 gauge group and 85 eyes in the 23 gauge group. The groups were well matched for surgical complexity and indications for surgery, as well as a variety of other preoperative variables. There was a significant reduction in the incidence of peripheral sclerotomy-related retinal breaks and lesions suspicious for breaks (4/85 [5%] 23 gauge versus 14/85 [16%] 20 gauge, P = 0.02) and posterior retinal breaks (3/85 [4%] 23 gauge versus 12/85 [14%] 20 gauge, P = 0.03). Six eyes (7%) in total had definite new retinal breaks of any type detected in the 23 gauge group compared with 16 (18.8%) in the 20 gauge group (P = 0.04). One patient in each group experienced a retinal detachment postoperatively related in both cases to a posterior retinal break associated with recurrent traction. CONCLUSION: In this series of patients, 23 gauge transconjunctival vitrectomy surgery was associated with a lower rate of retinal break formation than 20 gauge vitrectomy for proliferative diabetic retinopathy.

10.
BMC Ophthalmol ; 8: 19, 2008 Oct 13.
Artigo em Inglês | MEDLINE | ID: mdl-18851731

RESUMO

BACKGROUND: To assess the occurrence and magnitude of refractive change in pseudophakic eyes undergoing 20 gauge pars plana vitrectomy without scleral buckling and to investigate possible aetiological factors. METHODS: Retrospective case note review of 87 pseudophakic eyes undergoing 20 gauge pars plana vitrectomy for a variety of vitreo-retinal conditions over a three-year period. Anterior chamber depth (ACD) was measured before and after vitrectomy surgery in 32 eyes. Forty-three pseudophakic fellow eyes were used as controls. RESULTS: Eighty-seven eyes (84 patients) were included in the study. Mean spherical equivalent refraction prior to vitrectomy was -0.20 dioptres, which changed to a mean of -0.65 dioptres postoperatively (standard deviation of refractive change 0.59, range-2.13 to 0.75 dioptres) (p < 0.001). Sixty-one of the 87(70%) eyes experienced a myopic shift and 45(52%) eyes had a myopic shift of -0.5 dioptres or more. Mean fellow eye refraction was -0.19 dioptres preoperatively and -0.17 dioptres postoperatively (p = 0.14)(n = 37)Mean ACD preoperatively was 3.29 mm and postoperatively 3.27 mm (p = 0.53) (n = 32) and there was no significant change in ACD with tamponade use. Regression analysis revealed no statistically significant association between changes in anterior chamber depth, as well as a wide variety of other pre-, intra and postoperative factors examined, and the refractive change observed. CONCLUSION: Significant refractive changes occur in some pseudophakic patients undergoing 20 g pars plana vitrectomy. The mean change observed was a small myopic shift but the range was large. The aetiology of the refractive change is uncertain.


Assuntos
Miopia/etiologia , Miopia/fisiopatologia , Complicações Pós-Operatórias , Pseudofacia/cirurgia , Refração Ocular , Vitrectomia , Adulto , Idoso , Idoso de 80 Anos ou mais , Câmara Anterior/patologia , Oftalmopatias/cirurgia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pseudofacia/patologia , Doenças Retinianas/cirurgia , Estudos Retrospectivos , Corpo Vítreo
11.
BMC Ophthalmol ; 8: 13, 2008 Jul 23.
Artigo em Inglês | MEDLINE | ID: mdl-18651983

RESUMO

BACKGROUND: Stereoscopic assessment of the optic disc morphology is an important part of the care of patients with glaucoma. The aim of this study was to assess stereoviewing of stereoscopic optic disc images using an example of the new technology of autostereoscopic screens compared to the liquid shutter goggles. METHODS: Independent assessment of glaucomatous disc characteristics and measurement of optic disc and cup parameters whilst using either an autostereoscopic screen or liquid crystal shutter goggles synchronized with a view switching display. The main outcome measures were inter-modality agreements between the two used modalities as evaluated by the weighted kappa test and Bland Altman plots. RESULTS: Inter-modality agreement for measuring optic disc parameters was good [Average kappa coefficient for vertical Cup/Disc ratio was 0.78 (95% CI 0.62-0.91) and 0.81 (95% CI 0.6-0.92) for observer 1 and 2 respectively]. Agreement between modalities for assessing optic disc characteristics for glaucoma on a five-point scale was very good with a kappa value of 0.97. CONCLUSION: This study compared two different methods of stereo viewing. The results of assessment of the different optic disc and cup parameters were comparable using an example of the newly developing autostereoscopic display technologies as compared to the shutter goggles system used. The Inter-modality agreement was high. This new technology carries potential clinical usability benefits in different areas of ophthalmic practice.


Assuntos
Técnicas de Diagnóstico Oftalmológico , Glaucoma de Ângulo Aberto/diagnóstico , Processamento de Imagem Assistida por Computador/métodos , Hipertensão Ocular/diagnóstico , Disco Óptico/patologia , Doenças do Nervo Óptico/diagnóstico , Idoso , Diagnóstico Diferencial , Progressão da Doença , Feminino , Glaucoma de Ângulo Aberto/complicações , Humanos , Pressão Intraocular , Masculino , Pessoa de Meia-Idade , Hipertensão Ocular/complicações , Doenças do Nervo Óptico/etiologia , Reprodutibilidade dos Testes
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