Treatment of optic neuritis with erythropoietin (TONE): a randomised, double-blind, placebo-controlled trial-study protocol.

INTRODUCTION Optic neuritis leads to degeneration of retinal ganglion cells whose axons form the optic nerve. The standard treatment is a methylprednisolone pulse therapy. This treatment slightly shortens the time of recovery but does not prevent neurodegeneration and persistent visual impairment. In a phase II trial performed in preparation of this study, we have shown that erythropoietin protects global retinal nerve fibre layer thickness (RNFLT-G) in acute optic neuritis; however, the preparatory trial was not powered to show effects on visual function. METHODS AND ANALYSIS Treatment of Optic Neuritis with Erythropoietin (TONE) is a national, randomised, double-blind, placebo-controlled, multicentre trial with two parallel arms. The primary objective is to determine the efficacy of erythropoietin compared to placebo given add-on to methylprednisolone as assessed by measurements of RNFLT-G and low-contrast visual acuity in the affected eye 6 months after randomisation. Inclusion criteria are a first episode of optic neuritis with decreased visual acuity to ≤0.5 (decimal system) and an onset of symptoms within 10 days prior to inclusion. The most important exclusion criteria are history of optic neuritis or multiple sclerosis or any ocular disease (affected or non-affected eye), significant hyperopia, myopia or astigmatism, elevated blood pressure, thrombotic events or malignancy. After randomisation, patients either receive 33 000 international units human recombinant erythropoietin intravenously for 3 consecutive days or placebo (0.9% saline) administered intravenously. With an estimated power of 80%, the calculated sample size is 100 patients. The trial started in September 2014 with a planned recruitment period of 30 months. ETHICS AND DISSEMINATION TONE has been approved by the Central Ethics Commission in Freiburg (194/14) and the German Federal Institute for Drugs and Medical Devices (61-3910-4039831). It complies with the Declaration of Helsinki, local laws and ICH-GCP. TRIAL REGISTRATION NUMBER NCT01962571.

Multiple retinal detachment surgery: A functional outcome study. The Houston Vision Assessment Test-Retina (HVAT-Retina)

Retinal detachment is a common ophthalmologic procedure, and outcome is typically measured by a single factor-improvement in visual acuity. Health related functional outcome testing, which quantifies patient's self-reported perception of impairment, can be integrated with objective clinical findings. Based on the patient's self-assessed lifestyle impairment, the physician and patient together can make an informed decision on the treatment that is most likely to benefit the patient. ^ A functional outcome test (the Houston Vision Assessment Test-Retina; HVAT-Retina) was developed and validated in patients with multiple retinal detachments in the same eye. The HVAT-Retina divides an estimated total impairment into subcomponents: contribution of visual disability (potentially correctable by retinal detachment surgery) and nonvisual physical disabilities (co-morbidities not affected by retinal detachment surgery. ^ Seventy-six patients participated in this prospective multicenter study. Seven patients were excluded from the analysis because they were not certain of their answers. Cronbach's alpha coefficient was 0.91 for presurgery HVAT-Retina and 0.94 post-surgery. The item-to-total correlation ranged from 0.50 to 0.88. Visual impairment score improved by 9 points from pre-surgery (p = 0.0003). Physical impairment score also improved from pre-surgery (p = 0.0002). ^ In conclusion, the results of this study demonstrate that the instrument is reliable and valid in patients presenting with recurrent retinal detachments. The HVAT-Retina is a simple instrument and does not burden the patient or the health professional in terms of time or cost. It may be self-administrated, not requiring an interviewer. Because the HVAT-Retina was designed to demonstrate outcomes perceivable by the patient, it has the potential to guide the decision making process between patient and physician. ^

Cataract surgery in cancer patients and its impact on quality of life as measured by the National Eye Institute Visual Functioning Questionnaire - 25 (NEI-VFQ-25)

Purpose. The measurement of quality of life has become an important topic in healthcare and in the allocation of limited healthcare resources. Improving the quality of life (QOL) in cancer patients is paramount. Cataract removal and lens implantation appears to improve patient well-being of cancer patients, though a formal measurement has never been published in the US literature. In this current study, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25), a validated vision quality of life metric, was used to study the change in vision-related quality of life in cancer patients who underwent cataract extraction with intraocular lens implantation. ^ Methods. Under an IRB approved protocol, cancer patients who underwent cataract surgery with intraocular lens implantation (by a single surgeon) from December 2008 to March 2011, and who had completed a pre- and postoperative NEI-VFQ-25 were retrospectively reviewed. Post-operative data was collected at their routine 4-6 week post-op visit. Patients' demographics, cancer history, their pre and postoperative ocular examinations, visual acuities, and NEI-VFQ-25 with twelve components were included in the evaluation. The responses were evaluated using the Student t test, Spearman correlation and Wilcoxon signed rank test. ^ Results. 63 cases of cataract surgery (from 54 patients) from the MD Anderson Cancer Center were included in the study. Cancer patients had a significant improvement in the visual acuity (P<0.0001) postoperatively, along with a significant increase in vision-related quality of life (P<0.0001). Patients also had a statistically significant improvement in ten of the twelve subcategories which are addressed in the NEI-VFQ-25. ^ Conclusions. In our study, cataract extraction and intraocular implantation showed a significant impact on the vision-related quality of life in cancer patients. Although this study includes a small sample size, it serves as a positive pilot study to evaluate and quantify the impact of a surgical intervention on QOL in cancer patients and may help to design a larger study to measure vision related QOL per dollar spent for health care cost in cancer patients.^

Requirement of the nicotinic acetylcholine receptor β2 subunit for the anatomical and functional development of the visual system

In the mammalian visual system the formation of eye-specific layers at the thalamic level depends on retinal waves of spontaneous activity, which rely on nicotinic acetylcholine receptor activation. We found that in mutant mice lacking the β2 subunit of the neuronal nicotinic receptor, but not in mice lacking the α4 subunit, retinofugal projections do not segregate into eye-specific areas, both in the dorso-lateral geniculate nucleus and in the superior colliculus. Moreover, β2−/− mice show an expansion of the binocular subfield of the primary visual cortex and a decrease in visual acuity at the cortical level but not in the retina. We conclude that the β2 subunit of the nicotinic acetylcholine receptor is necessary for the anatomical and functional development of the visual system.

Cystoid Macular Edema: Causes, Diagnosis and Treatment

The purpose of this paper is to conduct a review of studies on cystoid macular edema published in the last seven years. Cystoid macular edema is a major cause of loss of visual acuity. It is the final common pathway of many diseases and can be caused by numerous processes including inflammatory, vascular, adverse drug reactions, retinal dystrophy or intraocular tumors. These processes disrupt the blood-retinal barrier, with fluid extravasation to the macular parenchyma. Imaging tests are essential for both detection and monitoring of this pathology. Fluorescein angiography and autofluorescence show the leakage of liquid from perifoveal vessels into the tissue where it forms cystic spaces. Optical coherence tomography is currently the gold standard technique for diagnosis and monitoring. This allows objective measurement of retinal thickness, which correlates with visual acuity and provides more complete morphological information. Based on the underlying etiology, the therapeutic approach can be either surgical or medical with anti-inflammatory drugs. We found that disruption of the blood-retinal barrier for various reasons is the key point in the pathogenesis of cystoid macular edema, therefore we believe that studies on its treatment should proceed on this path.

Stability of a Novel Intraocular Lens Design: Comparison of Two Trifocal Lenses

PURPOSE: To compare visual outcomes, rotational stability, and centration in a randomized controlled trial in patients undergoing cataract surgery who were bilaterally implanted with two different trifocal intraocular lenses (IOLs) with a similar optical zone but different haptic shape. METHODS: Twenty-one patients (42 eyes) with cataract and less than 1.50 D of corneal astigmatism underwent implantation of one FineVision/MicoF IOL in one eye and one POD FineVision IOL in the contralateral eye (PhysIOL, Liège, Belgium) at IOA Madrid Innova Ocular, Madrid, Spain. IOL allocation was random. Outcome measures, all evaluated 3 months postoperatively, included monocular and binocular uncorrected distance (UDVA), corrected distance (CDVA), distance-corrected intermediate (DCIVA), and near (DCNVA) visual acuity (at 80, 40, and 25 cm) under photopic conditions, refraction, IOL centration, haptic rotation, dysphotopsia, objective quality of vision and aberration quantification, patient satisfaction, and spectacle independence. RESULTS: Three months postoperatively, mean monocular UDVA, CDVA, DCIVA, and DCNVA (40 cm) under photopic conditions were 0.04 ± 0.07, 0.01 ± 0.04, 0.15 ± 0.11, and 0.16 ± 0.08 logMAR for the eyes implanted with the POD FineVision IOL and 0.03 ± 0.05, 0.01 ± 0.02, 0.17 ± 0.12, and 0.14 ± 0.08 logMAR for those receiving the FineVision/MicroF IOL. Moreover, the POD FineVision IOL showed similar centration (P > .05) and better rotational stability (P < .05) than the FineVision/MicroF IOL. Regarding halos, there was a minimal but statistically significant difference, obtaining better results with FineVision/MicroF. Full spectacle independence was reported by all patients. CONCLUSIONS: This study revealed similar visual outcomes for both trifocal IOLs under test (POD FineVision and FineVision/MicroF). However, the POD FineVision IOL showed better rotational stability, as afforded by its design.

Surgical outcomes of isolated lens coloboma with or without cataract among young adults

Objective: To evaluate the visual and refractive outcomes after phacoemulsification surgery in eyes with isolated lens coloboma. Design: Prospective, consecutive case series. Participants: Eighteen eyes with isolated lens coloboma of 13 patients were included in the study. Mean patient age was 13.9 ± 6.5 years. Methods: Patients underwent phacoemulsification surgery, with combined implantation of capsular tension ring (CTR) and intraocular lens. In colobomas of less than 120°, a CTR was used, whereas in colobomas of more than 120°, a Cionni-modified single eyelet CTR was used to achieve better capsular centration. The main outcome measures were uncorrected distance visual acuity, corrected distance visual acuity, refraction, and keratometry. Results: Mean logMAR uncorrected distance visual acuity and corrected distance visual acuity improved significantly from 1.53 ± 0.35 and 1.02 ± 0.47 before surgery to 0.67 ± 0.51 and 0.52 ± 0.49 at the last visit of the follow-up (p < 0.001). Mean refractive cylinder and spherical equivalent decreased significantly from –6.73 ± 1.73 and –6.72 ± 4.07 D preoperatively to –1.40 ± 1.39 and –0.83 ± 1.31 D at the end of the follow-up (p = 0.001 and p = 0.01, respectively). Mean keratometric astigmatism at preoperative and postoperative visits were 1.58 ± 0.97 and 1.65 ± 0.94 D, respectively (p = 0.70). Conclusions: Phacoemulsification with CTR and intraocular lens implantation is an effective and safe option for providing a refractive correction and a significant visual improvement in eyes with isolated lens coloboma.

Visual and optical performance and quality of life after implantation of posterior chamber phakic intraocular lens

Purpose To evaluate visual, optical, and quality of life (QoL) outcomes and intercorrelations after bilateral implantation of posterior chamber phakic intraocular lenses. Methods Twenty eyes with high to moderate myopia of 10 patients that underwent PRL implantation (Phakic Refractive Lens, Carl Zeiss Meditec AG) were examined. Refraction, visual acuity, photopic and low mesopic contrast sensitivity (CS) with and without glare, ocular aberrations, as well as QoL outcomes (National Eye Institute Refractive Error Quality of Life Instrument-42, NEI RQL-42) were evaluated at 12 months postoperatively. Results Significant improvement in uncorrected (UDVA) and best-corrected distance (CDVA) visual acuities were found postoperatively (p < 0.01), with significant reduction in spherical equivalent (p < 0.01). Low mesopic CS without glare was significantly better than measurements with glare for 1.5, 3, and 6 cycles/degree (p < 0.01). No significant correlations between higher order root mean square (RMS) with CDVA (r = −0.26, p = 0.27) and CS (r ≤ 0.45, p ≥ 0.05) were found. Postoperative binocular photopic CS for 12 cycles/degree and 18 cycles/degree correlated significantly with several RQL-42 scales. Glare index correlated significantly with CS measures and scotopic pupil size (r = −0.551, p = 0.04), but not with higher order RMS (r = −0.02, p = 0.94). Postoperative higher order RMS, postoperative primary coma and postoperative spherical aberration was significant higher for 5-mm pupil diameter (p < 0.01) compared with controls. Conclusions Correction of moderate to high myopia by means of PRL implantation had a positive impact on CS and QoL. The aberrometric increase induced by the surgery does not seem to limit CS and QoL. However, perception of glare is still a relevant disturbance in some cases possibly related to the limitation of the optical zone of the PRL.

Evaluation of Binocular Vision Therapy Efficacy by 3D Video-Oculography Measurement of Binocular Alignment and Motility

Objective: To evaluate two cases of intermittent exotropia (IX(T)) treated by vision therapy the efficacy of the treatment by complementing the clinical examination with a 3-D video-oculography to register and to evidence the potential applicability of this technology for such purpose. Methods: We report the binocular alignment changes occurring after vision therapy in a woman of 36 years with an IX(T) of 25 prism diopters (Δ) at far and 18 Δ at near and a child of 10 years with 8 Δ of IX(T) in primary position associated to 6 Δ of left eye hypotropia. Both patients presented good visual acuity with correction in both eyes. Instability of ocular deviation was evident by VOG analysis, revealing also the presence of vertical and torsional components. Binocular vision therapy was prescribed and performed including different types of vergence, accommodation, and consciousness of diplopia training. Results: After therapy, excellent ranges of fusional vergence and a “to-the-nose” near point of convergence were obtained. The 3-D VOG examination (Sensoro Motoric Instruments, Teltow, Germany) confirmed the compensation of the deviation with a high level of stability of binocular alignment. Significant improvement could be observed after therapy in the vertical and torsional components that were found to become more stable. Patients were very satisfied with the outcome obtained by vision therapy. Conclusion: 3D-VOG is a useful technique for providing an objective register of the compensation of the ocular deviation and the stability of the binocular alignment achieved after vision therapy in cases of IX(T), providing a detailed analysis of vertical and torsional improvements.

Comparative Analysis of the Visual Performance After Cataract Surgery With Implantation of a Bifocal or Trifocal Diffractive IOL

PURPOSE: To evaluate and compare the visual, refractive, contrast sensitivity, and aberrometric outcomes with a diffractive bifocal and trifocal intraocular lens (IOL) of the same material and haptic design. METHODS: Sixty eyes of 30 patients undergoing bilateral cataract surgery were enrolled and randomly assigned to one of two groups: the bifocal group, including 30 eyes implanted with the bifocal diffractive IOL AT LISA 801 (Carl Zeiss Meditec, Jena, Germany), and the trifocal group, including eyes implanted with the trifocal diffractive IOL AT LISA tri 839 MP (Carl Zeiss Meditec). Analysis of visual and refractive outcomes, contrast sensitivity, ocular aberrations (OPD-Scan III; Nidek, Inc., Gagamori, Japan), and defocus curve were performed during a 3-month follow-up period. RESULTS: No statistically significant differences between groups were found in 3-month postoperative uncorrected and corrected distance visual acuity (P > .21). However, uncorrected, corrected, and distance-corrected near and intermediate visual acuities were significantly better in the trifocal group (P < .01). No significant differences between groups were found in postoperative spherical equivalent (P = .22). In the binocular defocus curve, the visual acuity was significantly better for defocus of -0.50 to -1.50 diopters in the trifocal group (P < .04) and -3.50 to -4.00 diopters in the bifocal group (P < .03). No statistically significant differences were found between groups in most of the postoperative corneal, internal, and ocular aberrations (P > .31), and in contrast sensitivity for most frequencies analyzed (P > .15). CONCLUSIONS: Trifocal diffractive IOLs provide significantly better intermediate vision over bifocal IOLs, with equivalent postoperative levels of visual and ocular optical quality.

Visual function alterations in essential tremor: A case report

Our purpose is to report alterations in contrast sensitivity function (CSF) and in the magno, parvo and koniocellular visual pathways by means of a multichannel perimeter in case of an essential tremor (ET). A complete evaluation of the visual function was performed in a 69-year old patient, including the analysis of the chromatic discrimination by the Fansworth–Munsell 100 hue test, the measurement of the CSF by the CSV-1000E test, and the detection of potential alteration patterns in the magno, parvo and koniocellular visual pathways by means of a multichannel perimeter. Visual acuity and intraocular pressure (IOP) were within the ranges of normality in both eyes. No abnormalities were detected in the fundoscopic examination and in the optical coherence tomography (OCT) exam. The results of the color vision examination were also within the ranges of normality. A significant decrease in the achromatic CSFs for right eye (RE) and left eye (LE) was detected for all spatial frequencies. The statistical global values provided by the multichannel perimeter confirms that there were significant absolute sensitivity losses compared to the normal pattern in RE. In the LE, only a statistically significant decrease in sensitivity was detected for the blue-yellow (BY) channel. The pattern standard deviation (PSD) values obtained in our patient indicated that there were significant localized losses compared to the normality pattern in the achromatic channel of the RE and in the red-green (RG) channel of the LE. Some color vision alterations may be present in ET that cannot be detected with conventional color vision tests, such as the FM 100 Hue.

Comparative analysis of the visual performance and aberrometric outcomes with a new hybrid and two silicone hydrogel multifocal contact lenses: a pilot study

Background: The aim was to evaluate the visual performance achieved with a new multifocal hybrid contact lens and to compare it with that obtained with two other currently available multifocal soft contact lenses. Methods: This pilot prospective comparative study comprised a total of 16 presbyopic eyes of eight patients ranging in age from 43 to 58 years. All patients were fitted with three different models of multifocal contact lens: Duette multifocal (SynergEyes), Air Optix AQUA multifocal (Alcon) and Biofinity multifocal (CooperVision). Fittings were performed randomly in each patient according to a random number sequence, with a wash-out period between fittings of seven days. At two weeks post-fitting, visual, photopic contrast sensitivity and ocular aberrometry were evaluated. Results: No statistically significant differences were found in distance and near visual acuity achieved with the three different types of multifocal contact lens (p ≥ 0.05). Likewise, no significant differences between lenses were found in the monocular and binocular defocus curve (p ≥ 0.10). Concerning contrast sensitivity, better monocular contrast sensitivities for 6, 12 and 18 cycles per degree were found with the Duette and Air Optix multifocal compared to Biofinity (p = 0.02). Binocularly, differences between lenses were not significant (p ≥ 0.27). Furthermore, trefoil aberration was significantly higher with Biofinity multifocal (p < 0.01) and Air Optix (p = 0.01) multifocal compared to Duette. Conclusions: The Duette multifocal hybrid contact lens seems to provide similar visual quality outcomes in presbyopic patients with low corneal astigmatism, when compared with other soft multifocal contact lenses. This preliminary result should be confirmed in studies with larger samples.

Fixation pattern analysis with microperimetry in nystagmus patients

Objective: To assess the usefulness of microperimetry (MP) as an additional objective method for characterizing the fixation pattern in nystagmus. Design: Prospective study. Participants: Fifteen eyes of 8 subjects (age, 12–80 years) with nystagmus from the Lluís Alcanyís Foundation (University of Valencia, Spain) were included. Methods: All patients had a comprehensive ophthalmologic examination including a microperimetric examination (MAIA, CenterVue, Padova, Italy). The following microperimetric parameters were evaluated: average threshold (AT), macular integrity index (MI), fixating points within a circle of 1° (P1) and 2° of radius (P2), bivariate contour ellipse area (BCEA) considering 63% and 95% of fixating points, and horizontal and vertical axes of that ellipse. Results: In monocular conditions, 6 eyes showed a fixation classified as stable, 6 eyes showed a relatively unstable fixation, and 3 eyes showed an unstable fixation. Statistically significant differences were found between the horizontal and vertical components of movement (p = 0.001), as well as in their ranges (p < 0.001). Intereye comparison showed differences between eyes in some subjects, but only statistically significant differences were found in the fixation coordinates X and Y (p < 0.001). No significant intereye differences were found between microperimetric parameters. Between monocular and binocular conditions, statistically significant differences in the X and Y coordinates were found in all eyes (p < 0.02) except one. No significant differences were found between MP parameters for monocular or binocular conditions. Strong correlations of corrected distance visual acuity (CDVA) with AT (r = 0.812, p = 0.014), MI (r = –0.812, p = 0.014), P1 (r = 0.729, p = 0.002), horizontal diameter of BCEA (r = –0.700, p = 0.004), and X range (r = –0.722, p = 0.005) were found. Conclusions: MP seems to be a useful technology for the characterization of the fixation pattern in nystagmus, which seems to be related to the level of visual acuity achieved by the patient.

Baixa visual em crianças do ensino fundamental do município do Recife

Enquadramento: O acesso à saúde ocular em escolares dirige primariamente a prevenção de problemas visuais que dificultem o aprendizado, impossibilitando o desenvolvimento das atividades intelectuais e sociais. Os projetos de promoção da saúde oftalmológica são, para a grande maioria dos alunos, a primeira e rara oportunidade de avaliar a visão. Objetivos: Identificar os tipos de déficit visuais mais comuns nas crianças da região metropolitana do Recife; Identificar as queixas mais frequentes relacionadas a baixa de visão; Realizar campanha preventiva para identificação dos déficits, tendo como referência a Guarnição de Aeronáutica de Recife (GAR). Métodos: Estudo descritivo, transversal, intervencionista e quantitativo. A pesquisa ocorreu nos anos de 2013 e 2014, em uma população de 1500 crianças residentes na cidade de Recife, estado de Pernambuco, Brasil, com idades variando entre 7 e 9 anos, onde obtivemos uma amostra de 490 inscrições para participação no programa. Resultados: No primeiro período, atingimos 98,5% de objetividade, aumentando para 99,3% no segundo período. Os estudantes realizaram as consultas maioritariamente pela manhã (58,7%), em escola particular (81,6%) e na sua maioria (57,1%), eram do sexo feminino. A presença de queixas atingiu 78,6% e os sinais e sintomas mais referidos foram: cefaleia (20,8%), prurido ocular (17,6%) e dificuldade de enxergar o quadro (16,8%). Foram identificados e corrigidos 53 casos de erros de refração sendo o astigmatismo (4,74%), o mais diagnosticado, 7 casos de estrabismo e tratados 12 de conjuntivite. Conclusões: Em 2013, 15,1% e em 2014, 14,2% das crianças apresentaram baixa acuidade visual. Astigmatismo e miopia representam 10% dos problemas mais comuns seguidos de hipermetropia e conjuntivite. 84% do total de nossa amostra refere dificuldade de visualização no quadro negro, 68% manifestam cefaleias, 85% dor ocular, 75,5% vermelhidão ocular e 80,3% prurido ocular. Resumindo, os distúrbios visuais são comuns nas crianças, justificando programas de saúde preventiva nas unidades de saúde da FAB. Palavras-chave: Acuidade visual; Criança; Preventiva.

Field study of driver visual performance during rainfall. Final report.

National Highway Traffic Safety Administration, Washington, D.C.