Ranibizumab 0.5 mg for diabetic macular edema with bimonthly monitoring after a phase of initial treatment:18-month, multicenter, phase IIIB RELIGHT study

Abstract PURPOSE: To evaluate ranibizumab 0.5 mg using bimonthly monitoring and individualized re-treatment after monthly follow-up for 6 months in patients with visual impairment due to diabetic macular edema (DME). DESIGN: A phase IIIb, 18-month, prospective, open-label, multicenter, single-arm study in the United Kingdom. PARTICIPANTS: Participants (N = 109) with visual impairment due to DME. METHODS: Participants received 3 initial monthly ranibizumab 0.5 mg injections (day 0 to month 2), followed by individualized best-corrected visual acuity (BCVA) and optical coherence tomography-guided re-treatment with monthly (months 3-5) and subsequent bimonthly follow-up (months 6-18). Laser was allowed after month 6. MAIN OUTCOME MEASURES: Mean change in BCVA from baseline to month 12 (primary end point), mean change in BCVA and central retinal thickness (CRT) from baseline to month 18, gain of ≥10 and ≥15 letters, treatment exposure, and incidence of adverse events over 18 months. RESULTS: Of 109 participants, 100 (91.7%) and 99 (90.8%) completed the 12 and 18 months of the study, respectively. The mean age was 63.7 years, the mean duration of DME was 40 months, and 77.1% of the participants had received prior laser treatment (study eye). At baseline, mean BCVA was 62.9 letters, 20% of patients had a baseline BCVA of >73 letters, and mean baseline CRT was 418.1 μm, with 32% of patients having a baseline CRT <300 μm. The mean change in BCVA from baseline to month 6 was +6.6 letters (95% confidence interval [CI], 4.9-8.3), and after institution of bimonthly treatment the mean change in BCVA at month 12 was +4.8 letters (95% CI, 2.9-6.7; P < 0.001) and +6.5 letters (95% CI, 4.2-8.8) at month 18. The proportion of participants gaining ≥10 and ≥15 letters was 24.8% and 13.8% at month 12 and 34.9% and 19.3% at month 18, respectively. Participants received a mean of 6.8 and 8.5 injections over 12 and 18 months, respectively. No new ocular or nonocular safety findings were observed during the study. CONCLUSIONS: The BCVA gain achieved in the initial 6-month treatment period was maintained with an additional 12 months of bimonthly ranibizumab PRN treatment.

The benefit of combining standard automated perimetry and multifocal visual evoked potential hemifield intersector analysis in suspecious glaucomatous visual field defects

Several analysis protocols have been tested to identify early visual field losses in glaucoma patients using the mfVEP technique, some were successful in detection of field defects, which were comparable to the standard SAP visual field assessment, and others were not very informative and needed more adjustment and research work. In this study we implemented a novel analysis approach and evaluated its validity and whether it could be used effectively for early detection of visual field defects in glaucoma. The purpose of this study is to examine the benefit of adding mfVEP hemifield Intersector analysis protocol to the standard HFA test when there is suspicious glaucomatous visual field loss. 3 groups were tested in this study; normal controls (38 eyes), glaucoma patients (36 eyes) and glaucoma suspect patients (38 eyes). All subjects had a two standard Humphrey visual field HFA test 24-2, optical coherence tomography of the optic nerve head, and a single mfVEP test undertaken in one session. Analysis of the mfVEP results was done using the new analysis protocol; the Hemifield Sector Analysis HSA protocol. The retinal nerve fibre (RNFL) thickness was recorded to identify subjects with suspicious RNFL loss. The hemifield Intersector analysis of mfVEP results showed that signal to noise ratio (SNR) difference between superior and inferior hemifields was statistically significant between the 3 groups (ANOVA p<0.001 with a 95% CI). The difference between superior and inferior hemispheres in all subjects were all statistically significant in the glaucoma patient group 11/11 sectors (t-test p<0.001), partially significant 5/11 in glaucoma suspect group (t-test p<0.01) and no statistical difference between most sectors in normal group (only 1/11 was significant) (t-test p<0.9). Sensitivity and specificity of the HSA protocol in detecting glaucoma was 97% and 86% respectively, while for glaucoma suspect were 89% and 79%. The use of SAP and mfVEP results in subjects with suspicious glaucomatous visual field defects, identified by low RNFL thickness, is beneficial in confirming early visual field defects. The new HSA protocol used in the mfVEP testing can be used to detect glaucomatous visual field defects in both glaucoma and glaucoma suspect patient. Using this protocol in addition to SAP analysis can provide information about focal visual field differences across the horizontal midline, and confirm suspicious field defects. Sensitivity and specificity of the mfVEP test showed very promising results and correlated with other anatomical changes in glaucoma field loss. The Intersector analysis protocol can detect early field changes not detected by standard HFA test.

Ciliary muscle morphology in emmetropia and ocular biometric correlates

Purpose: Recent studies have documented a link between axial myopia and ciliary muscle morphology; yet, the variation in biometric characteristics of the emmetropic ciliary muscle are not fully known. Ciliary muscle morphology, including symmetry, was investigated between both eyes of emmetropic participants and correlated to ocular biometric parameters. Methods: Anterior segment optical coherence tomography (Zeiss, Visante) was utilised to image both eyes of 49 emmetropic participants (mean spherical equivalent refractive error (MSE) ≥ -0.55; < +0.75 D), aged 19 to 26 years. High resolution images were obtained of nasal and temporal aspects of the ciliary muscle in the relaxed state. MSE of both eyes was recorded using the Grand Seiko WAM 5500; axial length (AXL), anterior chamber depth (ACD) and lens thickness (LT) of the right eye were obtained using the Haag-streit Lenstar LS 900 biometer. A bespoke semi-objective analysis programme was used to measure a range of ciliary muscle parameters. Results: Temporal ciliary muscle overall length (CML) was greater than nasal CML, in both eyes (right: 3.58 ± 0.40 mm and 3.85 ± 0.39 mm for nasal and temporal aspects, respectively, P < 0.001; left: 3.65 ± 0.35 mm and 3.88 ± 0.41 mm for nasal and temporal aspects, respectively, P < 0.001). Temporal ciliary muscle thickness (CMT) was greater than nasal CMT at 2 mm and 3 mm from the scleral spur (CM2 and CM3, respectively) in each eye (right CM2: 0.29 ± 0.05 mm and 0.32 ± 0.05 mm for nasal and temporal aspects, respectively, P < 0.001; left CM2: 0.30 ± 0.05 mm and 0.32 ± 0.05 mm for nasal and temporal aspects, respectively, P < 0.001; right CM3: 0.13 ± 0.05 mm and 0.16 ± 0.04 mm for nasal and temporal aspects, respectively, P < 0.001; left CM3: 0.14 ± 0.04 mm and 0.17 ± 0.05 mm for nasal and temporal aspects, respectively, P < 0.001). AXL was positively correlated with ciliary muscle anterior length (AL) (e.g. P < 0.001, r2 = 0.262 for left temporal aspect), CML (P = 0.003, r2 = 0.175 for right nasal aspect) and ACD (P = 0.01, r2 = 0.181). Conclusions: Morphological characteristics of the ciliary muscle in emmetropic eyes display high levels of symmetry between the eyes. Greater CML and AL are linked to greater AXL and ACD, indicating ciliary muscle growth with normal ocular development.

Development of Multi-modal and Super-resolved Retinal Imaging Systems

Advancements in retinal imaging technologies have drastically improved the quality of eye care in the past couple decades. Scanning laser ophthalmoscopy (SLO) and optical coherence tomography (OCT) are two examples of critical imaging modalities for the diagnosis of retinal pathologies. However current-generation SLO and OCT systems have limitations in diagnostic capability due to the following factors: the use of bulky tabletop systems, monochromatic imaging, and resolution degradation due to ocular aberrations and diffraction.

Bulky tabletop SLO and OCT systems are incapable of imaging patients that are supine, under anesthesia, or otherwise unable to maintain the required posture and fixation. Monochromatic SLO and OCT imaging prevents the identification of various color-specific diagnostic markers visible with color fundus photography like those of neovascular age-related macular degeneration. Resolution degradation due to ocular aberrations and diffraction has prevented the imaging of photoreceptors close to the fovea without the use of adaptive optics (AO), which require bulky and expensive components that limit the potential for widespread clinical use.

In this dissertation, techniques for extending the diagnostic capability of SLO and OCT systems are developed. These techniques include design strategies for miniaturizing and combining SLO and OCT to permit multi-modal, lightweight handheld probes to extend high quality retinal imaging to pediatric eye care. In addition, a method for extending true color retinal imaging to SLO to enable high-contrast, depth-resolved, high-fidelity color fundus imaging is demonstrated using a supercontinuum light source. Finally, the development and combination of SLO with a super-resolution confocal microscopy technique known as optical photon reassignment (OPRA) is demonstrated to enable high-resolution imaging of retinal photoreceptors without the use of adaptive optics.

Toward A Reliable Quality Control Test For Microneedle Insertion

Microneedles (MNs) are emerging devices that can be used for the delivery of drugs at specific locations1. Their performance is primarily judged by different features and the penetration through tissue is one of the most important aspects to evaluate. For detailed studies of MN performance different kind of in-vitro, exvivo and in-vivo tests should be performed. The main limitation of some of these tests is that biological tissue is too heterogeneous, unstable and difficult to obtain. In addition the use of biological materials sometimes present legal issues. There are many studies dealing with artificial membranes for drug diffusion2, but studies of artificial membranes for Microneedle mechanical characterization are scarce3. In order to overcome these limitations we have developed tests using synthetic polymeric membranes instead of biological tissue. The selected artificial membrane is homogeneous, stable, and readily available. This material is mainly composed of a roughly equal blend of a hydrocarbon wax and a polyolefin and it is commercially available under the brand name Parafilm®. The insertion of different kind of MN arrays prepared from crosslinked polymers were performed using this membrane and correlated with the insertion of the MN arrays in ex-vivo neonatal porcine skin. The insertion depth of the MNs was evaluated using Optical coherence tomography (OCT). The implementation of MN transdermal patches in the market can be improved by make this product user-friendly and easy to use. Therefore, manual insertion is preferred to other kind of procedures. Consequently, the insertion studies were performed in neonatal porcine skin and the artificial membrane using a manual insertion force applied by human volunteers. The insertion studies using manual forces correlated very well with the same studies performed with a Texture Analyzer equipment. These synthetic membranes seem to mimic closely the mechanical properties of the skin for the insertion of MNs using different methods of insertion. In conclusion, this artificial membrane substrate offers a valid alternative to biological tissue for the testing of MN insertion and can be a good candidate for developing a reliable quality control MN insertion test.

The Use of a Pressure-Indicating Sensor Film to Provide Feedback upon Hydrogel-Forming Microneedle Array Self-Application In Vivo

PURPOSE:
To evaluate the combination of a pressure-indicating sensor film with hydrogel-forming microneedle arrays, as a method of feedback to confirm MN insertion in vivo.
METHODS:
Pilot in vitro insertion studies were conducted using a Texture Analyser to insert MN arrays, coupled with a pressure-indicating sensor film, at varying forces into excised neonatal porcine skin. In vivo studies involved twenty human volunteers, who self-applied two hydrogel-forming MN arrays, one with a pressure-indicating sensor film incorporated and one without. Optical coherence tomography was employed to measure the resulting penetration depth and colorimetric analysis to investigate the associated colour change of the pressure-indicating sensor film.
RESULTS:
Microneedle insertion was achieved in vitro at three different forces, demonstrating the colour change of the pressure-indicating sensor film upon application of increasing pressure. When self-applied in vivo, there was no significant difference in the microneedle penetration depth resulting from each type of array, with a mean depth of 237 μm recorded. When the pressure-indicating sensor film was present, a colour change occurred upon each application, providing evidence of insertion.
CONCLUSIONS:
For the first time, this study shows how the incorporation of a simple, low-cost pressure-indicating sensor film can indicate microneedle insertion in vitro and in vivo, providing visual feedback to assure the user of correct application. Such a strategy may enhance usability of a microneedle device and, hence, assist in the future translation of the technology to widespread clinical use.

Tomografia a coerenza ottica: principi ed applicazioni

La tomografia a coerenza ottica (Optical Coherence Tomography, OCT) rappresenta fondamentalmente una nuova modalità di diagnostica per immagini non invasiva e ad alta risoluzione. L’OCT fornisce immagini, sotto forma di sezioni trasversali o tomografiche, delle microstrutture dei tessuti biologici tramite la misura del ritardo dell’eco e dell’intensità della luce retrodiffusa o riflessa dal campione in analisi. L’OCT è una potente tecnica poiché fornisce in tempo reale immagini in situ delle strutture tissutali normali o patologiche, con una risoluzione da 1 a 15 micron, che è da uno a due ordini di grandezza maggiore rispetto alle tecniche per immagini convenzionali come ultrasuoni, risonanza magnetica o tomografia computerizzata. Tutto questo senza la necessità di ottenere e analizzare un campione tramite biopsia e studio istopatologico. Sin dall’inizio della sua utilizzazione nel 1991, l’OCT è stata impiegata in un vasto spettro di applicazioni cliniche, principalmente l'oftalmologia. In strutture non trasparenti, diverse da quelle oculari, la profondità massima esplorabile è limitata a 2-3 mm a causa dei fenomeni di attenuazione secondari e alla dispersione della luce. Inoltre, i numerosi sviluppi fatti dalla tecnologia OCT hanno portato ad alte velocità di acquisizione e, grazie all’utilizzo di sorgenti laser di ultima generazione, risoluzioni assiali dell’ordine di 1 micrometro. Dunque, la tomografia a coerenza ottica può essere sfruttata: - Quando la biopsia escissionale è pericolosa o impossibile. - Quando si rischiano errori di campionamento, come guida alla biopsia in modo da ridurre errori nel prelievo del campione. - Come guida alla procedura d’intervento, in associazione alle procedure di cateterismo, endoscopia e laparoscopia.

Sequential Morphological Changes in the CNV Net after Intravitreal Anti-VEGF Evaluated with OCT Angiography

PURPOSE: To assess and describe sequential morphological changes in the choroidal neovascularization (CNV) net using optical coherence tomography angiography (OCTA) in patients undergoing treatment with intravitreal antivascular endothelial growth factor (VEGF). METHODS: Prospective cohort study. OCTA was performed sequentially: before (t0), 1 h (t1), 1 week (t2) and 1 month after the injection (t3), using Avanti RTVue XR equipped with the AngioVue® software (Optovue, Calif., USA). All images were classified by two independent graders. RESULTS: Ten eyes of 10 patients, with a mean age of 72.4 ± 10.5 years, were included. CNV morphology was described as tree-like in 5 eyes, glomerular in 1 and fragmented in 4. A fibrovascular capsule surrounding the CNV net was found in 4 eyes and a feeder trunk was noticed in 6. No changes were observed at t1. Loss of peripheral capillaries, vessel fragmentation and decreased vessel density were evident in 8 eyes at t2. The CNV capillary density and the peripheral anastomosis increased in all of these at t3. Two eyes remained unchanged through the whole length of follow-up. CONCLUSIONS: Significant changes in the CNV net can be observable in OCTA at least 1 week after intravitreal anti-VEGF. The safety of frequent examinations may provide a method of gauging treatment effects.

Ocular manifestations of microcephaly with or without chorioretinopathy, lymphedema or intellectual disability (MCLID) syndrome associated with mutations in KIF11

Purpose Microcephaly with or without chorioretinopathy, lymphedema or intellectual disability (MCLID) is an autosomal dominant condition. Mutations in KIF11 have been found to be causative in approximately 75% of cases. This study describes the ocular phenotype in patients with confirmed KIF11 mutations. Methods Standard ophthalmic examination and investigation including visual acuity, refraction and fundus examination was carried out in all patients. Fundus autofluorescence imaging (FAF) was performed in three patients, and four patients underwent spectral domain optical coherence tomography (OCT). Flash electroretinography (ERG) was performed in seven patients, and five underwent additional pattern electroretinography (PERG). Results The patients ranged in age from 2 to 10 years. Most presented with visual acuity loss. Fundus examination revealed lacunae of chorioretinal atrophy. Pigmentary macular changes and optic disc pallor were present in three of seven patients. Fundus autofluorescence demonstrated hypoautofluorescence at the macula in two of three patients. The lacunae of chorioretinal atrophy were hypoautofluorescent. The OCT showed atrophic maculae in three of four patients. Follow-up in one patient showed no deterioration of the vision over a 9-year period. The lesions appear not to be progressive on the follow-up imaging. Electrophysiology showed generalized rod and cone dysfunction and severe macular dysfunction. Inner retinal dysfunction was evident in three of seven patients. Conclusions Patients with KIF11 mutations show a specific ocular phenotype with variable expressivity and intrafamilial variability. Macular atrophy and dysfunction have not been consistently documented before. The fundus lesions appear non-progressive. The findings assist in providing an accurate diagnosis and thus improving the management and follow-up of patients with this syndrome.

Sequential Morphological Changes in the CNV Net after Intravitreal Anti-VEGF Evaluated with OCT Angiography

PURPOSE: To assess and describe sequential morphological changes in the choroidal neovascularization (CNV) net using optical coherence tomography angiography (OCTA) in patients undergoing treatment with intravitreal antivascular endothelial growth factor (VEGF). METHODS: Prospective cohort study. OCTA was performed sequentially: before (t0), 1 h (t1), 1 week (t2) and 1 month after the injection (t3), using Avanti RTVue XR equipped with the AngioVue® software (Optovue, Calif., USA). All images were classified by two independent graders. RESULTS: Ten eyes of 10 patients, with a mean age of 72.4 ± 10.5 years, were included. CNV morphology was described as tree-like in 5 eyes, glomerular in 1 and fragmented in 4. A fibrovascular capsule surrounding the CNV net was found in 4 eyes and a feeder trunk was noticed in 6. No changes were observed at t1. Loss of peripheral capillaries, vessel fragmentation and decreased vessel density were evident in 8 eyes at t2. The CNV capillary density and the peripheral anastomosis increased in all of these at t3. Two eyes remained unchanged through the whole length of follow-up. CONCLUSIONS: Significant changes in the CNV net can be observable in OCTA at least 1 week after intravitreal anti-VEGF. The safety of frequent examinations may provide a method of gauging treatment effects.

Purtscher-like retinopathy

Purtscher-like retinopathy is associated with retinal hemorrhages and ischaemia probably due to the complement-mediated leukoembolization. It is a rare and severe angiopathy found in conditions such as acute pancreatitis. Case. We present a case of a 53-year-old man who presented with a Purtscher-like retinopathy associated with the development of acute pancreatitis in the context of a Klatskin tumour (a hilar cholangiocarcinoma). The ophthalmologic evaluation revealed the best corrected visual acuity (BCVA) of 20/32 in the right eye (RE) and of 20/40 in the left eye (LE); biomicroscopy of anterior segment showed scleral icterus and fundoscopy revealed peripapillary cotton-wool spots, optic disc edema, and RPE hypo- and hyperpigmentation in the middle peripheral retina in both eyes with an intraretinal hemorrhage in the LE. 15 months after the initial presentation, without ophthalmological treatment, there was an improvement of BCVA to 20/20 in both eyes and optical coherence tomography (OCT) revealed areas of reduction of retinal nerve fiber layer thickness corresponding to the previous cotton-wool spots. Conclusion. Purtscher-like retinopathy should not be neglected in complex clinical contexts. Its unclear pathophysiology determines an uncertain treatment strategy, but a meticulous follow-up is compulsory in order to avoid its severe complications.

In vivo microvascular oximetry using multispectral imaging

This thesis describes the application of multispectral imaging to several novel oximetry applications. Chapter 1 motivates optical microvascular oximetry, outlines oxygen transport in the body, describes the theory of oximetry, and describes the challenges associated with in vivo oximetry, in particular imaging through tissue. Chapter 2 reviews various imaging techniques for quantitative in vivo oximetry of the microvasculature, including multispectral and hyperspectral imaging, photoacoustic imaging, optical coherence tomography, and laser speckle techniques. Chapter 3 describes a two-wavelength oximetry study of two microvascular beds in the anterior segment of the eye: the bulbar conjunctival and episcleral microvasculature. This study reveals previously unseen oxygen diffusion from ambient air into the bulbar conjunctival microvasculature, altering the oxygen saturation of the bulbar conjunctiva. The response of the bulbar conjunctival and episcleral microvascular beds to acute mild hypoxia is quantified and the rate at which oxygen diffuses into bulbar conjunctival vessels is measured. Chapter 4 describes the development and application of a highly novel non-invasive retinal angiography technique: Oximetric Ratio Contrast Angiography (ORCA). ORCA requires only multispectral imaging and a small perturbation of blood oxygen saturation to produce angiographic sequences. A pilot study of ORCA in human subjects was conducted. This study demonstrates that ORCA can produce angiographic sequences with features such as sequential vessel filling and laminar flow. The application and challenges of ORCA are discussed, with emphasis on comparison with other angiography techniques, such as fluorescein angiography. Chapter 5 describes the development of a multispectral microscope for oximetry in the spinal cord dorsal vein of rats. Measurements of blood oxygen saturation are made in the dorsal vein of both healthy rats, and in rats with the Experimental autoimmune encephalomyelitis (EAE) disease model of multiple sclerosis. The venous blood oxygen saturation of EAE disease model rats was found to be significantly lower than that of healthy controls, indicating increased oxygen uptake from blood in the EAE disease model of multiple sclerosis. Chapter 6 describes the development of video-rate red eye oximetry; a technique which could enable stand-off oximetry of the blood-supply of the eye with high temporal resolution. The various challenges associated with video-rate red eye oximetry are investigated and their influence quantified. The eventual aim of this research is to track circulating deoxygenation perturbations as they arrive in both eyes, which could provide a screening method for carotid artery stenosis, which is major risk-factor for stroke. However, due to time constraints, it was not possible to thoroughly investigate if video-rate red eye can detect such perturbations. Directions and recommendations for future research are outlined.

The Impact of the Eye in Dementia: The Eye and its Role in Diagnosis and Follow‐up

Over the last few decades, the importance of ophthalmic examination in neurodegenerative diseases of the CNS has reportedly increased. The retina is an extension of the CNS and thus should not be surprising to find abnormal results in both the test exploring visual processing and those examining the retina of patients with CNS degeneration. Current in vivo imaging techniques are allowing ophthalmologists to detect and quantify data consistent with the histopathological findings described in the retinas of Alzheimer’s disease (AD) patients and may help to reveal unsuspected retinal and optic‐nerve repercussions of other CNS diseases. In this chapter, we perform an analysis of the physiological changes in ocular and cerebral ageing. We analyse the ocular manifestations in CNS disorders such as stroke, AD and Parkinson’s disease. In addition, the pathophysiology of both the eye and the visual pathway in AD are described. The value of the visual psychophysical tests in AD diagnosis is reviewed as well as the main findings of the optical coherence tomography as a contribution to the diagnosis and monitoring of the disease. Finally, we examine the association of two neurodegenerative diseases, AD and glaucoma, as mere coincidence or possible role in the progression of the neurodegeneration.

Clinical characteristics and selection of treatment modality for patients with vitreomacular traction:real-world implementation of NICE guidance (TA297)

Aim: To investigate the qualitative aspects in patient selection and the quantitative impact of disease burden in real world treatment of vitreomacular traction (VMT) and implementation of the National Institute for Health and Care Excellence (NICE) guidance (TA297). Methods: A monocentric, retrospective review of consecutive patients undergoing optical coherence tomography (OCT) imaging over a 3 month period. Patients with VMT in at least one eye were identified for further data collection on laterality, visual acuity, symptoms, presence of epiretinal membrane, macular hole and treatment selection. Results: A total of 3472 patients underwent OCT imaging with a total of 6878 eyes scanned. Out of 87 patients, 74 patients had unilateral VMT (38 right, 36 left) and 13 patients had bilateral VMT. Eighteen patients with unilateral VMT satisfied NICE criteria of severe sight problems in the affected eye. Eight were managed for a coexisting pathology, one refused treatment, one patient did not attend, two closed spontaneously, and one received ocriplasmin prior to the study start date. Only two patients with unilateral VMT received ocriplasmin and three underwent vitrectomy. Those failing to meet NICE criteria for unilateral VMT were predominantly asymptomatic (n=49) or had coexisting ERM (n=5) or both (n=2). Conclusion: Ocriplasmin provides an alternative treatment for patients with symptomatic VMT. Our data shows that the majority of patients with VMT do not meet NICE TA297 primarily due to lack of symptoms. Those meeting NICE criteria, but not treated, tended to have coexisting macular pathology. Variation in patient selection due to subjective factors not outlined in NICE guidance suggests that real world outcomes of ocriplasmin therapy should be interpreted with caution.

Hallazgos tomográficos como predictores del resultado funcional en edema macular secundario a oclusiones venosas retinianas

INTRODUCCIÓN: El Edema Macular (EM) es la principal causa de perdida de agudeza visual en pacientes con Oclusión Venosa Retiniana (OVR); luego del tratamiento, algunos pacientes persisten con mala agudeza visual. OBJETIVO: Realizar una Revisión Sistemática de la Literatura (RSL), para identificar la evidencia existente sobre factores tomográficos que predicen el resultado visual en pacientes con EM secundario a OVR. FUENTE DE LA INFORMACIÓN: PUBMED, MEDLINE, EMBASE, LILACS, COCHRANE, literatura gris. SELECCIÓN DE LOS ESTUDIOS: Ensayos Clínicos Controlados (ECC) y estudios observacionales analíticos. EXTRACCIÓN Y SÍNTESIS DE LOS DATOS: Dos investigadores seleccionaron los artículos de forma independiente. Se realizó una síntesis cualitativa de la información siguiendo las recomendaciones de la declaración PRISMA 2009. MEDIDAS Y DESENLACE PRINCIPAL: Grosor Retiniano Central (GRC), integridad de Banda Elipsoide e Integridad de Membrana Limitante Externa (MLE), determinados por SD OCT. El desenlace principal es la Agudeza Visual Mejor Corregida (AVMC) a los 6, 12,18 y/o 24 meses. RESULTADOS: Se identificaron 872 abstract y se incluyeron 8 artículos en el análisis cualitativo. Seis estudios evaluaron el GRC sin encontrar asociación con resultado visual final. Solo 2 estudios evaluaron y encontraron asociación estadísticamente significativa de la integridad de la MLE con el desenlace visual, Kang, H 2012 (r2 0,51 p 0,000), Rodriguez, F 2014 (p< 0,001). La integridad de la BE fue asociada a pronostico visual en 4 de 5 estudios que evaluaron esta variable, con resultados estadísticamente significativos. La AVMC de base también se asocio con desenlace visual en 4 de 5 estudios que la evaluaron. El mejor modelo que predice el resultado funcional según el estudio de Kang, H 2012 fue: Integridad de MLE, integridad de BE y AVMC de base (R2 0,671 p 0,000), a los 12 meses de seguimiento. CONCLUSION: La evidencia actual sugiere que la integridad de la BE y la MLE son predictores del resultados funcional en pacientes con EM secundario a OVR después de 6 o mas meses de seguimiento. Es necesario la realización de estudios controlados para llegar a resultados mas concluyentes.