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1.
Ophthalmology ; 123(6): 1287-96, 2016 06.
Artículo en Inglés | MEDLINE | ID: mdl-27086023

RESUMEN

PURPOSE: To assess the safety and efficacy of epimacular brachytherapy (EMB) for patients with chronic, active, neovascular age-related macular degeneration (AMD). DESIGN: Phase 3 randomized controlled trial. PARTICIPANTS: Patients (n = 363) with neovascular AMD already receiving intravitreal ranibizumab injections. INTERVENTION: Either pars plana vitrectomy with 24-gray EMB and ongoing pro re nata (PRN) ranibizumab (n = 224) or ongoing PRN ranibizumab monotherapy (n = 119). MAIN OUTCOME MEASURES: The coprimary outcomes, at 12 months, were the number of PRN ranibizumab injections and Early Treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (VA). Secondary outcomes included the proportion of participants losing fewer than 15 ETDRS letters, angiographic total lesion size, choroidal neovascularization (CNV) size, and optical coherence tomography (OCT) foveal thickness. A predefined subgroup analysis tested the influence of baseline ocular characteristics on the response to EMB. RESULTS: The mean number of PRN ranibizumab injections was 4.8 in the EMB arm and 4.1 in the ranibizumab monotherapy arm (P = 0.068). The mean VA change was -4.8 letters in the EMB arm and -0.9 letters in the ranibizumab arm (95% confidence interval of difference between groups, -6.6 to -1.8 letters). The proportion of participants losing fewer than 15 letters was 84% in the EMB arm and 92% in the ranibizumab arm (P = 0.007). In the EMB arm, the mean total lesion size increased by 1.2 mm(2) versus 0.4 mm(2) in the ranibizumab arm (P = 0.27). The CNV size decreased by 0.5 mm(2) in the EMB arm and by 1.3 mm(2) in the ranibizumab arm (P = 0.27). The OCT foveal thickness decreased by 1.0 µm in the EMB arm and by 15.7 µm in the ranibizumab arm (P = 0.43). Most subgroups favored ranibizumab monotherapy, some significantly so. One participant showed retinal vascular abnormality attributed to radiation, but otherwise safety was acceptable. CONCLUSIONS: These results do not support the use of EMB for chronic, active, neovascular AMD. Safety is acceptable out to 12 months, but radiation retinopathy can occur later, so further follow-up is planned.


Asunto(s)
Braquiterapia/métodos , Radioisótopos de Estroncio/uso terapéutico , Degeneración Macular Húmeda/radioterapia , Anciano , Anciano de 80 o más Años , Inhibidores de la Angiogénesis/uso terapéutico , Braquiterapia/efectos adversos , Enfermedad Crónica , Femenino , Angiografía con Fluoresceína , Humanos , Inyecciones Intravítreas , Mácula Lútea , Masculino , Persona de Mediana Edad , Traumatismos por Radiación/etiología , Ranibizumab/uso terapéutico , Retina/efectos de la radiación , Terapia Recuperativa , Radioisótopos de Estroncio/efectos adversos , Tomografía de Coherencia Óptica , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Vitrectomía , Degeneración Macular Húmeda/diagnóstico , Degeneración Macular Húmeda/tratamiento farmacológico
2.
Retina ; 34(5): 874-9, 2014 May.
Artículo en Inglés | MEDLINE | ID: mdl-24169101

RESUMEN

PURPOSE: To evaluate the safety and efficacy of epimacular brachytherapy for the treatment of chronic, active neovascular age-related macular degeneration. METHODS: A prospective, multicenter, interventional noncontrolled clinical trial recruited 53 participants with previously treated neovascular age-related macular degeneration. Participants underwent pars plana vitrectomy with a single 24 Gray dose of epimacular brachytherapy, delivered using an intraocular cannula containing a Strontium 90/Yttrium 90 source that was positioned over the active lesion. Participants were retreated with ranibizumab, administered monthly as needed, using predefined retreatment criteria. Coprimary outcomes at 24 months were the proportion of participants losing <15 Early Treatment of Diabetic Retinopathy Study letters and mean number of ranibizumab retreatments. RESULTS: Over 24 months, 68.1% lost <15 letters with a mean of 8.7 ranibizumab retreatments. Mean change in visual acuity was -6.3 (standard deviation, 18.9) letters. There was one case of nonproliferative radiation retinopathy. CONCLUSION: The apparent reduction in ranibizumab retreatment was less evident in Year 2 than Year 1, with the moderate reduction in visual acuity extending into the second year. Although radiation retinopathy occurred in one case, it was not vision threatening and safety remained acceptable.


Asunto(s)
Braquiterapia , Membrana Epirretinal/radioterapia , Radioisótopos de Estroncio/uso terapéutico , Degeneración Macular Húmeda/tratamiento farmacológico , Degeneración Macular Húmeda/radioterapia , Radioisótopos de Itrio/uso terapéutico , Anciano , Anciano de 80 o más Años , Inhibidores de la Angiogénesis/uso terapéutico , Anticuerpos Monoclonales Humanizados/uso terapéutico , Enfermedad Crónica , Femenino , Angiografía con Fluoresceína , Humanos , Inyecciones Intravítreas , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Dosificación Radioterapéutica , Radioterapia Adyuvante , Ranibizumab , Tomografía de Coherencia Óptica , Resultado del Tratamiento , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Agudeza Visual/fisiología , Degeneración Macular Húmeda/fisiopatología
3.
Ophthalmology ; 120(2): 328-33, 2013 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-23178157

RESUMEN

PURPOSE: To report the optical coherence tomography (OCT) and fundus fluorescein angiography (FFA) results of the Macular Epiretinal Brachytherapy in Treated Age-Related Macular Degeneration study. DESIGN: Prospective, multicenter, interventional, noncontrolled clinical trial. PARTICIPANTS: Fifty-three eyes of 53 participants with chronic, active neovascular age-related macular degeneration (AMD) requiring frequent anti-vascular endothelial growth factor retreatment. METHODS: Participants underwent pars plana vitrectomy with a single 24-gray dose of epimacular brachytherapy (EMB), delivered with an intraocular, handheld, cannula containing a strontium 90/yttrium 90 source positioned over the active lesion. Participants were retreated with ranibizumab administered monthly as needed, using predefined retreatment criteria. Patients underwent FFA at baseline, month 1, and month 12. Patients underwent optical coherence tomography (OCT) at baseline and then monthly for 12 months. The FFA and OCT images were evaluated by independent, central reading facilities. MAIN OUTCOME MEASURES: Change in OCT centerpoint thickness and angiographic lesion size 12 months after EMB. RESULTS: Mean centerpoint thickness increased by 50 µm, from 186 to 236 µm (P = 0.292), but 70% of participants had an increase of less than the mean, with a median increase of only 1.8 µm. The FFA total lesion size increased slightly by 0.79 mm(2), from 14.69 to 15.48 mm(2) (P = 0.710). Total choroidal neovascularization (CNV) area increased by 1.17 mm(2), from 12.94 to 14.12 mm(2) (P = 0.556). The classic CNV area decreased substantially by 3.70 mm(2), from 3.90 to 0.20 mm(2) (P<0.01). Predominantly classic lesions showed the greatest response, with mean Early Treatment Diabetic Retinopathy Study visual acuity improving by 1.5 letters (versus -4.0 for all participants combined); mean centerpoint thickness decreased by 43 µm (P = 0.875). The angiographic and OCT response did not correlate with lesion size at baseline. CONCLUSIONS: In chronic, active, neovascular AMD, EMB is associated with nonsignificant changes in centerpoint thickness and FFA total lesion size over 12 months.


Asunto(s)
Braquiterapia , Membrana Epirretinal/radioterapia , Angiografía con Fluoresceína , Mácula Lútea/efectos de la radiación , Tomografía de Coherencia Óptica , Degeneración Macular Húmeda/radioterapia , Membrana Epirretinal/diagnóstico , Humanos , Mácula Lútea/patología , Estudios Prospectivos , Dosificación Radioterapéutica , Radioisótopos de Estroncio/uso terapéutico , Resultado del Tratamiento , Agudeza Visual/fisiología , Vitrectomía , Degeneración Macular Húmeda/diagnóstico , Radioisótopos de Itrio/uso terapéutico
4.
Ophthalmology ; 120(8): 1597-603, 2013 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-23490325

RESUMEN

PURPOSE: To report the fluorescein angiography (FA) and optical coherence tomography (OCT) results of a clinical trial of epimacular brachytherapy (EMBT) used for the treatment of neovascular age-related macular degeneration (AMD). DESIGN: Pivotal multicenter, active-controlled, randomized clinical trial. PARTICIPANTS: A total of 494 participants with treatment-naïve, neovascular AMD. METHODS: Participants with classic, minimally classic, and occult lesions were randomized to receive (a) EMBT and 2 mandated monthly ranibizumab injections followed by pro re nata (PRN) ranibizumab or (b) 3 mandated monthly ranibizumab injections followed by mandated quarterly plus PRN ranibizumab. Participants underwent FA at screening and at months 1, 6, 12, 18, and 24. Optical coherence tomography scans were undertaken monthly for 24 months. The FA and OCT images were analyzed at respective independent reading centers. MAIN OUTCOME MEASURES: Change at 24 months in mean FA total lesion size and choroidal neovascularization (CNV) size and change in mean OCT centerpoint thickness. RESULTS: The mean (standard deviation) changes in FA total lesion size in the EMBT and control arms were +1.9 (8.7) and -3.0 (7.2) mm(2), respectively, with a mean change in total CNV size of +0.4 (8.4) and -4.7 (6.5) mm(2), respectively. Mean (standard deviation) changes in OCT centerpoint thickness were -144 (246) and -221 (185) µm, respectively. Retrospective subgroup analyses showed no significant difference between treatment arms in mean centerpoint thickness in some subgroups, including eyes with classic lesions. The control arm showed a significantly larger reduction in mean total lesion size and mean CNV size than the EMBT arm in all subgroups analyzed. Nine eyes in the EMBT arm showed features consistent with mild, nonproliferative radiation retinopathy, but with a mean gain of 5.0 Early Treatment Diabetic Retinopathy Study letters. CONCLUSIONS: Both FA and OCT suggest that EMBT with PRN ranibizumab results in an inferior structural outcome than quarterly plus PRN ranibizumab. Some subgroup analyses suggest that classic lesions may be more responsive than occult lesions, although generally both subgroups are inferior to ranibizumab. A non-vision-threatening radiation retinopathy occurs in 2.9% of eyes over 24 months, but longer follow-up is needed. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.


Asunto(s)
Braquiterapia/métodos , Angiografía con Fluoresceína , Radioisótopos de Estroncio/uso terapéutico , Tomografía de Coherencia Óptica , Vitrectomía , Degeneración Macular Húmeda/terapia , Anciano , Anciano de 80 o más Años , Inhibidores de la Angiogénesis/uso terapéutico , Anticuerpos Monoclonales Humanizados/uso terapéutico , Braquiterapia/efectos adversos , Terapia Combinada , Femenino , Estudios de Seguimiento , Humanos , Masculino , Traumatismos por Radiación/diagnóstico , Traumatismos por Radiación/etiología , Ranibizumab , Retina/patología , Retina/efectos de la radiación , Radioisótopos de Estroncio/efectos adversos , Resultado del Tratamiento , Agudeza Visual/fisiología , Degeneración Macular Húmeda/diagnóstico , Degeneración Macular Húmeda/tratamiento farmacológico , Degeneración Macular Húmeda/radioterapia
5.
Retina ; 33(6): 1232-40, 2013 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-23508075

RESUMEN

PURPOSE: To determine if epimacular brachytherapy is associated with reduced retinal sensitivity or choroidal nonperfusion. METHODS: A prospective intervention case series of 12 participants with neovascular age-related macular degeneration requiring frequent ranibizumab underwent vitrectomy and epimacular brachytherapy. The Strontium 90/Yttrium 90 source delivered a single 24-Gy dose at the center of the treatment zone. The dose attenuated with increasing distance from the source. Microperimetry and indocyanine green angiography were performed at baseline and 12 months. The main outcome measures were mean sensitivity and choroidal nonperfusion. A linear mixed model was used to assess the association between the dose of radiation and the change in mean sensitivity. RESULTS: Mean visual acuity remained within 1 letter of baseline at 12 months (-0.33 ± 13.2 letters). There was no statistically significant change in mean sensitivity within the neovascular age-related macular degeneration lesion area (gain of 0.94 ± 3.25 dB; P = 0.339) or in neighboring unaffected retina (0.66 ± 4.14 dB; P = 0.594), defined using fluorescein angiography. Within the lesion area, mean sensitivity improved by an average of 0.23 ± 0.16 dB (P = 0.006) for every additional gray of radiation received. Indocyanine green angiography failed to demonstrate any choroidal nonperfusion or radiation damage at 12 months after the treatment. CONCLUSION: Stable retinal sensitivity in areas not manifestly affected by neovascular age-related macular degeneration suggests that epimacular brachytherapy does not damage retinal function. The presence of a dose response suggests that the positive effect of epimacular brachytherapy relates more to beta irradiation than vitrectomy.


Asunto(s)
Braquiterapia/efectos adversos , Degeneración Macular/radioterapia , Traumatismos por Radiación/diagnóstico , Retina/efectos de la radiación , Campos Visuales/fisiología , Anciano , Anciano de 80 o más Años , Inhibidores de la Angiogénesis/uso terapéutico , Anticuerpos Monoclonales Humanizados/uso terapéutico , Braquiterapia/métodos , Relación Dosis-Respuesta en la Radiación , Femenino , Angiografía con Fluoresceína/métodos , Humanos , Verde de Indocianina , Modelos Lineales , Degeneración Macular/fisiopatología , Degeneración Macular/terapia , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Ranibizumab , Umbral Sensorial/fisiología , Radioisótopos de Estroncio/efectos adversos , Radioisótopos de Estroncio/uso terapéutico , Tomografía de Coherencia Óptica , Agudeza Visual , Pruebas del Campo Visual , Vitrectomía , Radioisótopos de Itrio/efectos adversos , Radioisótopos de Itrio/uso terapéutico
6.
Orbit ; 32(6): 366-9, 2013 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-24063373

RESUMEN

PURPOSE: To review the management of inverted papillomas presenting to oculoplastic surgeons at three institutions and the outcomes of treatment. METHODS: A retrospective review of medical notes of patients presenting with inverted papillomas that invaded the orbit during a 7-year period. RESULTS: In total, six Caucasian patients were identified, the mean age at presentation was 63 years. The presenting features were nasal blockage, epiphora, proptosis and medial canthal mass. Four were classed as Stage IV and two as Stage III disease. The sites of origin were the lateral wall of the nose, frontal sinus, ethmoidal sinus and lacrimal system. The lesions were radiologically homogenous tumours with variable degrees of nose, paranasal sinuses and orbital involvement. Four out of six had foci of malignant transformation (two with carcinoma in situ and two with invasive squamous cell carcinoma). All were treated with surgical excision and three with adjunctive radiotherapy. One patient needed orbital exentration and subsequently died from complications of the tumour bleeding. CONCLUSION: Inverted papillomas that invade the orbit are likely to be malignant and locally aggressive tumours. Early and wide surgical excision provides the best chance of removal and minimises recurrence. Radiotherapy may be a useful adjunct. Following surgical intervention, all cases require long term observation to ensure tumour control.


Asunto(s)
Neoplasias Orbitales/patología , Papiloma Invertido/patología , Neoplasias de los Senos Paranasales/patología , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Invasividad Neoplásica , Estadificación de Neoplasias , Neoplasias Nasales/diagnóstico por imagen , Neoplasias Nasales/patología , Neoplasias Nasales/cirugía , Neoplasias Orbitales/diagnóstico por imagen , Neoplasias Orbitales/cirugía , Papiloma Invertido/diagnóstico por imagen , Papiloma Invertido/cirugía , Neoplasias de los Senos Paranasales/diagnóstico por imagen , Neoplasias de los Senos Paranasales/cirugía , Estudios Retrospectivos , Tomografía Computarizada por Rayos X
7.
Br J Ophthalmol ; 107(7): 987-992, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-35217515

RESUMEN

BACKGROUND/AIM: To assess the long-term safety and efficacy of epimacular brachytherapy (EMB) for chronic, active, neovascular age-related macular degeneration (nAMD). METHODS: This pivotal, randomised, controlled surgical device trial recruited patients with chronic nAMD receiving intravitreal ranibizumab from 24 UK hospitals. Participants were randomised to either pars plana vitrectomy with 24 Gray EMB and pro re nata (PRN) ranibizumab (n=224) or PRN ranibizumab monotherapy (n=119). Although masking was not possible, masked clinicians assessed best-corrected visual acuity (BCVA) and imaging. After month 24, participants reverted to standard care, with either ranibizumab or aflibercept, returning for a month 36 study visit. RESULTS: Of 363 participants, 309 (85.1%) completed month 36. The number of injections was 12.1±8.1 in the EMB group versus 11.4±6.1 in the ranibizumab group (difference 0.7, 95% CI of difference -0.9 to 2.3, p=0.41) between months 1 and 36, and 3.6±3.3 (n=200) versus 3.9±2.7 (n=102) (difference -0.3, 95% CI of difference -1.0 to 0.4, p=0.43) between months 25 and 36 (standard care). Over 36 months, BCVA change was -19.7±18.5 letters in the EMB group and -4.8±12.5 in the ranibizumab group (difference -14.9, 95% CI of difference -18.5 to -11.2, p<0.0001). The month 36 BCVA of 20 EMB-treated participants with microvascular abnormalities (MVAs) at month 24 was similar to EMB-treated participants without MVAs (-21.8 vs -19.4 letters, p=0.65). CONCLUSION: EMB does not reduce the number of anti-vascular endothelial growth factor (VEGF) injections, either within or outside of a trial setting, and is associated with worse BCVA than anti-VEGF monotherapy. TRIAL REGISTRATION NUMBER: NCT01006538.


Asunto(s)
Braquiterapia , Degeneración Macular , Degeneración Macular Húmeda , Humanos , Ranibizumab/uso terapéutico , Inhibidores de la Angiogénesis/uso terapéutico , Braquiterapia/métodos , Factores de Crecimiento Endotelial Vascular , Degeneración Macular/tratamiento farmacológico , Inyecciones Intravítreas , Resultado del Tratamiento , Degeneración Macular Húmeda/diagnóstico , Degeneración Macular Húmeda/tratamiento farmacológico , Degeneración Macular Húmeda/radioterapia
8.
Ophthalmology ; 119(7): 1425-31, 2012 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-22465819

RESUMEN

PURPOSE: To evaluate the safety and efficacy of epimacular brachytherapy (EMB) for the treatment of chronic, active, neovascular age-related macular degeneration (AMD). DESIGN: Prospective, multicenter, interventional, noncontrolled clinical trial. PARTICIPANTS: Fifty-three eyes of 53 participants with neovascular AMD requiring frequent anti-vascular endothelial growth factor (VEGF) retreatment. METHODS: Participants underwent pars plana vitrectomy with a single 24-Gy dose of EMB delivered using an intraocular, handheld cannula containing a strontium 90/yttrium 90 source positioned over the active lesion. Participants were retreated with ranibizumab administered monthly as needed, using predefined retreatment criteria. Optical coherence tomography (OCT) was undertaken monthly, with images assessed by an independent reading center. MAIN OUTCOME MEASURES: Coprimary outcomes at 12 months were proportion of participants with stable vision (losing <15 Early Treatment Diabetic Retinopathy Study [ETDRS] letters) and mean number of anti-VEGF retreatments. RESULTS: Before enrollment, participants had received an average of 12.5 anti-VEGF injections. After a single treatment with EMB, 81% maintained stable vision, with a mean of 3.49 anti-VEGF retreatments in 12 months. Mean ± standard deviation change in visual acuity was -4.0±15.1 ETDRS letters. Mean ± standard deviation OCT central retinal thickness increased by 50±179 µm. Common adverse events included conjunctival hemorrhage (n = 38), cataract (n = 16), resolving vitreous hemorrhage (n = 6), and eye pain (n = 5). CONCLUSIONS: Epimacular brachytherapy produces stable visual acuity in most participants with previously treated, active disease. Epimacular brachytherapy may reduce the need for frequent anti-VEGF retreatment.


Asunto(s)
Braquiterapia , Radioisótopos de Estroncio/uso terapéutico , Degeneración Macular Húmeda/radioterapia , Radioisótopos de Itrio/uso terapéutico , Anciano , Anciano de 80 o más Años , Inhibidores de la Angiogénesis/administración & dosificación , Anticuerpos Monoclonales Humanizados/administración & dosificación , Enfermedad Crónica , Femenino , Angiografía con Fluoresceína , Humanos , Inyecciones Intravítreas , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Dosificación Radioterapéutica , Ranibizumab , Retina/efectos de la radiación , Tomografía de Coherencia Óptica , Resultado del Tratamiento , Agudeza Visual/fisiología , Vitrectomía , Degeneración Macular Húmeda/tratamiento farmacológico , Degeneración Macular Húmeda/fisiopatología
9.
Acta Ophthalmol ; 98(8): e960-e967, 2020 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31674134

RESUMEN

PURPOSE: To determine the feasibility of a definitive study of intravitreal ranibizumab to promote the clearance of persistent diabetic vitreous haemorrhage and thereby avoid vitrectomy. METHODS: This randomised, double-masked, placebo-controlled feasibility study recruited 24 participants with persistent diabetic vitreous haemorrhage listed for pars plana vitrectomy. Participants were randomised to a single 0.5-mg intravitreal ranibizumab injection or a single subconjunctival saline injection. The primary outcome measure was the number of participants requiring pars plana vitrectomy at week 7. RESULTS: Eight of 12 participants (66.7%) in the ranibizumab group required vitrectomy at week 7 versus 12 of 12 (100%) in the placebo group (absolute risk reduction 33.3%, 95% confidence interval 2.1-70.7%; p = 0.09). One additional eye in the ranibizumab group required vitrectomy by 12 months. Mean visual acuity letter score at 12 months was 72.7 ± 12.3 in the ranibizumab group and 75.1 ± 10.1 in the placebo group. Safety was similar across groups. CONCLUSION: Intravitreal ranibizumab may reduce the likelihood of proceeding to vitrectomy in patients with persistent, dense diabetic vitreous haemorrhage. Further studies appear feasible and justified.


Asunto(s)
Bevacizumab/administración & dosificación , Retinopatía Diabética/complicaciones , Ranibizumab/administración & dosificación , Agudeza Visual , Hemorragia Vítrea/tratamiento farmacológico , Anciano , Anciano de 80 o más Años , Inhibidores de la Angiogénesis/administración & dosificación , Retinopatía Diabética/diagnóstico , Retinopatía Diabética/tratamiento farmacológico , Método Doble Ciego , Estudios de Factibilidad , Femenino , Estudios de Seguimiento , Humanos , Inyecciones Intravítreas , Masculino , Persona de Mediana Edad , Receptores de Factores de Crecimiento Endotelial Vascular , Estudios Retrospectivos , Hemorragia Vítrea/diagnóstico , Hemorragia Vítrea/etiología
10.
JAMA Ophthalmol ; 138(8): 835-842, 2020 08 01.
Artículo en Inglés | MEDLINE | ID: mdl-32644148

RESUMEN

Importance: Although anti-vascular endothelial growth factor (VEGF) treatment offers better outcomes than the natural history of neovascular age-related macular degeneration (ARMD), a less burdensome, less expensive, and more durable treatment is needed. Objective: To assess the efficacy and safety of epimacular brachytherapy (EMB) for chronic, active, neovascular ARMD. Design, Setting, and Participants: The Macular Epiretinal Brachytherapy vs Ranibizumab (Lucentis) Only Treatment (MERLOT) pivotal device trial was conducted at 24 National Health Service hospitals across the UK. Patients who had neovascular ARMD and received intravitreal ranibizumab were enrolled between November 10, 2009, and January 30, 2012. Eligible patients were randomized 2:1 and were stratified by lens status and angiographic lesion type to receive either EMB plus as-needed ranibizumab or as-needed ranibizumab monotherapy. Participants were followed up monthly for 24 months and then assessed at a final visit at month 36. Masking of participants and clinicians was not possible, but best-corrected visual acuity (BCVA) and imaging were analyzed by masked assessors. Analysis followed the intent-to-treat approach. Interventions: Pars plana vitrectomy with 24 Gy EMB plus as-needed ranibizumab vs as-needed ranibizumab monotherapy. Main Outcomes and Measures: Coprimary outcomes were the number of as-needed ranibizumab injections and the mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA with a noninferiority margin of -5 ETDRS letters. Secondary outcomes were the percentage of participants losing fewer than 15 ETDRS letters and gaining 0 or more or 15 or more ETDRS letters and the mean change in angiographic total lesion size, choroidal neovascularization size, and foveal thickness on optical coherence tomography. Results: Of 363 participants, 329 (90.6%) completed 24 months of follow-up (222 participants in the EMB group and 107 in the ranibizumab group). The mean (SD) age of the combined groups was 76.5 (7.4) years. The mean (SD) number of ranibizumab injections was 9.3 (6.7) in the EMB group and 8.3 (4.5) in the ranibizumab group, with a difference of 1.0 injection (95% CI, -0.3 to 2.3; P = .13). The mean (SD) BCVA change was -11.2 (15.7) ETDRS letters in the EMB group and -1.4 (10.9) ETDRS letters in the ranibizumab group, with a difference of 9.8 ETDRS letters (95% CI, -6.7 to -12.9). In the EMB group, 65.6% of participants (160 of 244) lost fewer than 15 ETDRS letters vs 86.6% (103 of 119) in the ranibizumab group, with a difference of 21% (95% CI, 12.4%-29.5%; P < .001). Microvascular abnormalities occurred in 20 of 207 eyes (9.7%) in the EMB group and 1 of 97 eyes (1.0%) in the ranibizumab group. These abnormalities occurred outside the foveal center, and there were no unexpected safety concerns. Conclusions and Relevance: The MERLOT trial found that despite the acceptable safety of EMB, it did not reduce the number of ranibizumab injections and was associated with worse visual acuity than anti-VEGF treatment alone; these results do not support EMB use as an adjunct treatment for chronic, active neovascular ARMD. Trial Registration: ClinicalTrials.gov Identifier: NCT01006538.


Asunto(s)
Inhibidores de la Angiogénesis/uso terapéutico , Braquiterapia , Neovascularización Coroidal/radioterapia , Radioisótopos de Estroncio/uso terapéutico , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Degeneración Macular Húmeda/radioterapia , Anciano , Anciano de 80 o más Años , Neovascularización Coroidal/tratamiento farmacológico , Neovascularización Coroidal/fisiopatología , Enfermedad Crónica , Femenino , Angiografía con Fluoresceína , Estudios de Seguimiento , Humanos , Inyecciones Intravítreas , Mácula Lútea/efectos de la radiación , Masculino , Dosificación Radioterapéutica , Ranibizumab/uso terapéutico , Retratamiento , Radioisótopos de Estroncio/efectos adversos , Tomografía de Coherencia Óptica , Resultado del Tratamiento , Agudeza Visual/fisiología , Vitrectomía , Degeneración Macular Húmeda/tratamiento farmacológico , Degeneración Macular Húmeda/fisiopatología
11.
Eye (Lond) ; 32(9): 1498-1503, 2018 09.
Artículo en Inglés | MEDLINE | ID: mdl-29802293

RESUMEN

AIM: To compare ophthalmology teaching delivered by eLearning with traditional lectures, in terms of undergraduate performance and satisfaction. METHODS: Randomised controlled crossover study at King's College London Medical School with 245 third year medical students. The ophthalmology syllabus was divided into ten topics. Five topics were randomised to be taught by traditional lectures and five by electronic learning (eLearning). For the second rotation of students the topics were crossed over, so that those topics taught by traditional lectures were taught by eLearning and vice versa. At the end of each rotation the students sat an optional online mock examination containing 100 questions (ten on each topic). Students' examination performance was compared between the two teaching methods. Student satisfaction was assessed using an online satisfaction survey. Outcome measures were the mean percentage of correct answers across all ten topics, student satisfaction and self-assessed knowledge. RESULTS: The mean examination score for questions taught by eLearning was 58% (95% CI, 55.7-59.6), versus 55% (95% CI 53.1-56.8) for traditional lectures (P = 0.047). Across all topics students were more satisfied with eLearning than traditional lectures, with 87% (95% CI 84.5-88.4) rating eLearning as 'excellent' or 'good' versus 65% (95% CI 62.0-67.4) for lectures (p < 0.0001). Overall 180 (75.6%) preferred eLearning compared to traditional lectures, with 166 (69.7%) rating eLearning 'much better' or 'better,' 61 (25.6%) 'neutral' and 11 (4.6%) 'worse' or 'much worse.' CONCLUSIONS: Student satisfaction and examination performance are both enhanced by ophthalmology eLearning. Similar eLearning modules may be suitable for other specialties and postgraduate learning.


Asunto(s)
Instrucción por Computador/métodos , Educación a Distancia/métodos , Educación de Pregrado en Medicina/métodos , Oftalmología/educación , Facultades de Medicina , Adulto , Estudios Cruzados , Educación a Distancia/normas , Femenino , Humanos , Internet , Masculino , Enseñanza
12.
Am J Ophthalmol ; 144(2): 227-231, 2007 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-17543875

RESUMEN

PURPOSE: To evaluate the long-term outcomes of keratoprosthesis as an alternative surgical procedure in the management of aniridic keratopathy. DESIGN: Retrospective, multicenter case series. METHODS: Fifteen adult patients (16 eyes) with aniridia who were deemed at high risk for regular donor corneal transplantation underwent a Boston type I keratoprosthesis procedure for visual rehabilitation. Device retention rate, preoperative and postoperative visual acuity, and intraoperative and postoperative complications were studied. RESULTS: The mean age of the patients was 45 (median 50) years. Six of the patients were females. Eleven patients had previously undergone donor corneal transplantations (average two grafts), with failure. In 10 patients, the keratoprosthesis surgery was combined with other procedures such as cataract extraction, tube shunt implantation, vitrectomy, and intraocular lens removal. No intraoperative complications were encountered. The follow-up ranged from two months to 85 months, with a median of 17 months. All devices remained in situ throughout the entire follow-up period. The visual acuity improved in all but one patient from a median of counting fingers (light perception to 20/300) to 20/200 (hand motions to 20/60). Comorbid preoperative conditions particularly optic nerve and foveal hypoplasia limited the final postoperative vision. No endophthalmitis or extrusion of the device occurred. One device required repair procedure without necessitating a removal. CONCLUSIONS: Keratoprosthesis offers significant vision benefits in this patient group.


Asunto(s)
Aniridia/cirugía , Córnea , Prótesis e Implantes , Implantación de Prótesis/instrumentación , Adulto , Anciano , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento , Agudeza Visual
13.
Eur J Ophthalmol ; 27(3): 342-345, 2017 May 11.
Artículo en Inglés | MEDLINE | ID: mdl-27739561

RESUMEN

PURPOSE: To report the response of participants switching from ranibizumab to aflibercept treatment for neovascular age-related macular degeneration (nAMD) requiring further anti-vascular endothelial growth factor treatment. METHODS: In this retrospective case review of 68 participants treated in a single hospital, all participants, prior to switching, received ranibizumab injections only. Best-corrected visual acuity (BCVA), clinical examination, and optical coherence tomography (OCT) were performed at each visit. Active nAMD was defined as persistent intraretinal or subretinal fluid on OCT. Participants had their first aflibercept injection at baseline and 2 more injections at 2 monthly intervals. Afterwards, they were followed up every 6-8 weeks and given injections as needed. The main outcome measures were visual acuity and the OCT central retinal thickness (CRT), average thickness (AT), and total macular volume (TMV). RESULTS: The BCVA at baseline visit was 0.57 ± 0.33 log MAR and the final BCVA was 0.54 ± 0.37 log MAR (p = 0.215). The CRT mean change was -75.6 ± 85.6 (p = 0.001), the AT mean change was -24.2 ± 27.2 (p = 0.001), and TMV mean change was -0.69 ± 0.78 (p = 0.001). There were no significant ophthalmic complications related to treatments. CONCLUSIONS: Intravitreal aflibercept improved anatomic outcomes (as measured by OCT) in eyes with nAMD that were previously treated with intravitreal ranibizumab and were still active. There was no statistically significant difference in logMAR visual acuity in participants who switched to aflibercept with a follow-up of at least 6 months.


Asunto(s)
Neovascularización Coroidal/tratamiento farmacológico , Degeneración Macular/tratamiento farmacológico , Ranibizumab/administración & dosificación , Receptores de Factores de Crecimiento Endotelial Vascular/administración & dosificación , Proteínas Recombinantes de Fusión/administración & dosificación , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Agudeza Visual , Anciano , Anciano de 80 o más Años , Inhibidores de la Angiogénesis/administración & dosificación , Neovascularización Coroidal/diagnóstico , Neovascularización Coroidal/etiología , Femenino , Angiografía con Fluoresceína , Fondo de Ojo , Humanos , Inyecciones Intravítreas , Degeneración Macular/complicaciones , Degeneración Macular/diagnóstico , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Tomografía de Coherencia Óptica , Resultado del Tratamiento
14.
BMJ Case Rep ; 20122012 Aug 27.
Artículo en Inglés | MEDLINE | ID: mdl-22927278

RESUMEN

Blunt ocular trauma from a child's plastic foam-covered toy baseball bat caused traumatic optic neuropathy and choroidal rupture in a 9-year-old child. The examination revealed a visual acuity of 6/60, a relative afferent pupillary defect, optic nerve swelling, commotio retinae and retinal haemorrhages. There was no orbital fracture or intraorbital haematoma on CT scanning. Optical coherence tomography showed macular oedema and disruption of the retinal pigment epithelium and Bruch's membrane. The child was admitted for intravenous methylprednisolone and discharged on topical steroid treatment. At 1 month follow-up, visual acuity had improved to 6/12. Optic nerve swelling had resolved and the fundus had two crescent-shaped choroidal rupture scars. Choroidal rupture and optic neuropathy can be secondary to indirect trauma, and even when the mechanism of injury is with a piece of equipment designated as suitable for children, serious ocular injury can occur.


Asunto(s)
Traumatismos en Atletas/etiología , Béisbol/lesiones , Coroides/lesiones , Seguridad de Productos para el Consumidor , Lesiones Oculares/etiología , Traumatismos del Nervio Óptico/etiología , Juego e Implementos de Juego/lesiones , Heridas no Penetrantes/etiología , Antiinflamatorios/administración & dosificación , Traumatismos en Atletas/diagnóstico , Lámina Basal de la Coroides/efectos de los fármacos , Lámina Basal de la Coroides/lesiones , Niño , Coroides/efectos de los fármacos , Ciclopentolato/administración & dosificación , Diagnóstico Diferencial , Quimioterapia Combinada , Lesiones Oculares/diagnóstico , Lesiones Oculares/tratamiento farmacológico , Angiografía con Fluoresceína , Estudios de Seguimiento , Humanos , Infusiones Intravenosas , Masculino , Metilprednisolona/administración & dosificación , Soluciones Oftálmicas , Traumatismos del Nervio Óptico/diagnóstico , Traumatismos del Nervio Óptico/tratamiento farmacológico , Epitelio Pigmentado Ocular/efectos de los fármacos , Epitelio Pigmentado Ocular/lesiones , Rotura , Tomografía de Coherencia Óptica , Tomografía Computarizada por Rayos X , Agudeza Visual/efectos de los fármacos , Heridas no Penetrantes/diagnóstico , Heridas no Penetrantes/tratamiento farmacológico
15.
Surv Ophthalmol ; 57(6): 498-509, 2012 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-23068973

RESUMEN

We explore the hypothesis that vitreomacular adhesion (VMA) and vitreomacular traction (VMT) play a role in the pathogenesis and clinical course of neovascular ("wet") age-related macular degeneration (AMD). Several biological theories are offered to explain this possible association, including direct tractional force, altered vitreous oxygenation, altered diffusion coefficients of intravitreal molecules, and alterations in the pharmacokinetics of intravitreal drugs. Release of VMT may improve the clinical course of neovascular AMD, and a few case series suggest that vitrectomy can lead to both a functional and anatomic improvement. A large, randomized, controlled clinical trial is underway, investigating pharmacologic release of VMA in eyes with neovascular AMD.


Asunto(s)
Oftalmopatías/complicaciones , Enfermedades de la Retina/complicaciones , Cuerpo Vítreo/patología , Degeneración Macular Húmeda/etiología , Oftalmopatías/diagnóstico , Oftalmopatías/cirugía , Humanos , Procedimientos Quirúrgicos Oftalmológicos , Enfermedades de la Retina/diagnóstico , Enfermedades de la Retina/cirugía , Adherencias Tisulares , Tomografía de Coherencia Óptica , Degeneración Macular Húmeda/diagnóstico , Degeneración Macular Húmeda/cirugía
16.
Retin Cases Brief Rep ; 6(4): 353-7, 2012.
Artículo en Inglés | MEDLINE | ID: mdl-25389929

RESUMEN

PURPOSE: The purpose of this study was to present a case of a retinal angiomatous proliferation (RAP) treated with epimacular brachytherapy that was refractory to continued ranibizumab therapy. PATIENTS: An interventional case report of an 89-year-old woman with angiographically confirmed RAP had shown a poor response to 8 anti-vascular endothelial growth factor (anti-vascular endothelial growth factor) retreatment injections over a 10-month period. METHODS: The patient underwent pars plana vitrectomy combined with beta irradiation of the RAP lesion using a Strontium-90 applicator (NeoVista). The device was positioned over the lesion to deliver 24 gray over 4.5 minutes. Early Treatment Diabetic Retinopathy Study best-corrected visual acuity with full refraction was undertaken monthly by trial-certified examiners, independent of the operating surgeon. The main outcome measures were Early Treatment Diabetic Retinopathy Study best-corrected visual acuity, central retinal thickness measured by optical coherence tomography, and the number of anti-vascular endothelial growth factor retreatments. RESULTS: Preoperative best-corrected visual acuity was 53 letters (20/80), improving to 69 letters (20/50) at 12 months and 71 letters (20/40) at 21 months. Only one ranibizumab retreatment was required, at Month 2. Optical coherence tomography central retinal thickness reduced from 312 µm to 224 µm with a return of the normal foveal contour. There was full regression of the RAP lesion on clinical examination, with a reduction in lesion activity demonstrated by fundus fluorescein angiography. CONCLUSION: This is the first reported case of RAP treated with epimacular brachytherapy, with encouraging results. Epimacular brachytherapy may be a new treatment option for refractory RAP lesions requiring frequent intravitreal ranibizumab, but further studies are needed.

17.
Clin Ophthalmol ; 5: 57-63, 2011 Jan 10.
Artículo en Inglés | MEDLINE | ID: mdl-21311657

RESUMEN

Antivascular endothelial growth factor (anti-VEGF) therapies represent the standard of care for most patients presenting with neovascular (wet) age-related macular degeneration (neovascular AMD). Anti-VEGF drugs require repeated injections and impose a considerable burden of care, and not all patients respond. Radiation targets the proliferating cells that cause neovascular AMD, including fibroblastic, inflammatory, and endothelial cells. Two new neovascular AMD radiation treatments are being investigated: epimacular brachytherapy and stereotactic radiosurgery. Epimacular brachytherapy uses beta radiation, delivered to the lesion via a pars plana vitrectomy. Stereotactic radiosurgery uses low voltage X-rays in overlapping beams, directed onto the lesion. Feasibility data for epimacular brachytherapy show a greatly reduced need for anti-VEGF therapy, with a mean vision gain of 8.9 ETDRS letters at 12 months. Pivotal trials are underway (MERLOT, CABERNET). Preliminary stereotactic radiosurgery data suggest a mean vision gain of 8 to 10 ETDRS letters at 12 months. A large randomized sham controlled stereotactic radiosurgery feasibility study is underway (CLH002), with pivotal trials to follow. While it is too early to conclude on the safety and efficacy of epimacular brachytherapy and stereotactic radiosurgery, preliminary results are positive, and these suggest that radiation offers a more durable therapeutic effect than intraocular injections.

19.
Ocul Immunol Inflamm ; 16(1): 45-9, 2008.
Artículo en Inglés | MEDLINE | ID: mdl-18379943

RESUMEN

PURPOSE: To report an atypical case of chorioretinopathy in a patient with bilateral renal transplantations. METHODS: A 55-year-old female was referred for management of birdshot chorioretinopathy. Ophthalmologic examination revealed bilateral yellowish, chorioretinal lesions with adjacent hemorrhages. RESULTS: Angiography demonstrated lesions with hyperfluorescence, leakage, and diffuse macular edema. OCT showed intraretinal edema. Laboratory evaluation revealed IgG antibodies for Bartonella hensalae. Treatment with oral ciprofloxacin led to regression of lesions, resolution of macular edema, and improvement in visual acuity. CONCLUSION: Multifocal chorioretinal lesions associated with B. hensalae can be atypical ophthalmic manifestations of cat-scratch disease (CSD), which may occur in immunosuppressed patients. Recognition of underlying disease and appropriate therapy can lead to improved outcomes.


Asunto(s)
Angiomatosis Bacilar , Coriorretinitis/microbiología , Huésped Inmunocomprometido , Angiomatosis Bacilar/tratamiento farmacológico , Antiinfecciosos , Formas Bacterianas Atípicas , Bartonella henselae , Coriorretinitis/diagnóstico , Ciprofloxacina/uso terapéutico , Femenino , Angiografía con Fluoresceína , Humanos , Trasplante de Riñón , Edema Macular/microbiología , Persona de Mediana Edad , Tomografía de Coherencia Óptica
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