Query: SEE Clinical Trial Ophthalmology

Candidate papers:

abstract: PurposeFrom an early stage, retinitis pigmentosa (RP) patients suffer from night blindness which causes nocturnal mobility difficulties. We created a wearable visual aid that uses a high performance see through display, and added a high sensitivity camera with a complementary metal oxide semiconductor sensor. Here, we evaluate the device's efficacy for helping night blindness sufferers walk in the dark.Study designProspective clinical study.MethodsTwenty eight subjects underwent binocular visual acuity testing in the dark without (power off) and with (power on) the device. The test was carried out in a darkened room. We recorded the number of trial errors and the time it took each subject to arrive at the goal both with and without the aid of our device.ResultsOur device effectively assists walking in RP patients with mobility problems in the dark.ConclusionBinocular visual acuity in the dark was significantly improved with the aid of our device. In the walking test, the number of errors decreased greatly with the device, and the travel time was significantly shortened.
author_names: Yasuhiro Ikeda

Shunji Nakatake

Jun Funatsu

Kohta Fujiwara

Takashi Tachibana

Yusuke Murakami

Toshio Hisatomi

Shigeo Yoshida

Hiroshi Enaida

Tatsuro Ishibashi

Koh-Hei Sonoda
title: Night vision aid using see through display for patients with retinitis pigmentosa
venue: Japanese Journal of Ophthalmology
year: 2018

abstract: Ranibizumab therapy is the first treatment for neovascular AMD to improve vision for most patients. The benefits apply to all angiographic subtypes of neovascular AMD and across all lesion sizes. Although the pivotal phase III trials (MARINA and ANCHOR) used monthly injections of ranibizumab for 2 years, the ongoing PIER, PrONTO, and SAILOR trials are investigating less frequent dosing regimens, and preliminary results from the PrONTO study suggest that fewer injections will most likely result in visual acuity improvements similar to the results from the phase III trials. When comparing the ANCHOR results with the FOCUS results, it also becomes apparent that the combination of ranibizumab with PDT does not necessarily result in better visual acuity outcomes, and the use of PDT may even reduce the visual acuity benefits achieved with ranibizumab alone (see Figs. 1 3) It seems unlikely that combination therapy provides any significant advantage over ranibizumab alone unless the combination of PDT and ranibizumab can decrease the need for frequent retreatment. The results from the PrONTO Study already suggest that less frequent treatment with ranibizumab is possible by using a variable dosing regimen with OCT. Ranibizumab also seems to be safe, with the 2 year MARINA data showing no increase in the incidence of systemic adverse events that could be associated with anti VEGF therapy, such as myocardial infarction and stroke. There was a hint of a safety concern, however, in the pooled 1 year safety results from the MARINA and ANCHOR trials. Although the combined rate of myocardial infarction and stroke during the first year of the ANCHOR and MARINA trials was similar in the control and the 0.3 mg ranibizumab arms (1.3% and 1.6% respectively) these adverse events were slightly higher in the 0.5 mg ranibizumab arm (2.9% These differences are not statistically significant, however, and probably do not represent a dose dependent increase in risk because the 2 year results from the MARINA trial with the same monthly injection regimen showed no increased risk of thromboembolic events. In December 2005, Genentech submitted a Biologics License Application to the FDA for the use of ranibizumab in the treatment of neovascular wet AMD based on 1 year clinical efficacy and safety data from the two pivotal phase III trials, ANCHOR and MARINA, and the phase I II FOCUS trial. Genentech has been granted a 6 month Priority Review from the FDA with a decision anticipated 6 months from the December submission date or by the end of June 2006 [29] By the summer of 2006, this revolutionary therapy should be available for the treatment of neovascular AMD. At that time, the major dilemma facing most retina specialists will be whether to use intravitreal ranibizumab or intravitreal bevacizumab, the low cost alternative, for the treatment of neovascular AMD.
author_names: Philip J Rosenfeld

Ryan M Rich

Geeta A Lalwani
title: Ranibizumab: Phase III clinical trial results.
venue: Ophthalmology clinics of North America
year: 2006

abstract: Loss of central vision from geographic atrophy (GA) is a late stage complication of age related macular degeneration (AMD) as the central foveal region becomes consumed by the disease. Until recently, GA had not received the attention it deserved from the pharmaceutical industry. Over the years, most of the clinical trial community has been focused on the exudative or neovascular form of AMD due to the rapid and severe vision loss often associated with this form of the disease. With the success of vascular endothelial growth factor inhibitors in slowing and preventing the devastating vision loss from neovascularization in exudative AMD, the development of macular atrophy after anti vascular endothelial growth factor therapy and growth of GA in nonexudative AMD have become the most common causes of vision loss from AMD. The research by Chakravarthy et al (see http: www.aaojournal.org/article/S0161 6420(17)32513 7/fulltext) in this issue highlights the enormous impact of GA in
author_names: Philip J Rosenfeld
title: Preventing the Growth of Geographic Atrophy: An Important Therapeutic Target in Age Related Macular Degeneration.
venue: Ophthalmology
year: 2018

abstract: PURPOSE The goal was to evaluate how perceptual thresholds are related to electrode impedance, electrode size, the distance of electrodes from the retinal surface, and retinal thickness in six subjects blind as a result of retinitis pigmentosa, who received epiretinal prostheses implanted monocularly as part of a U.S. Food and Drug Administration (FDA) approved clinical trial. METHODS The implant consisted of an extraocular unit containing electronics for wireless data, power recovery, and generation of stimulus current, and an intraocular unit containing 16 platinum stimulating electrodes (260 or 520 microm diameter) arranged in a 4 x 4 pattern. The electrode array was held onto the retina by a small tack. Stimulation was controlled by a computer based external system that allowed independent control over each electrode. Perceptual thresholds (the current necessary to see a percept on 79% of trials) and impedance were measured for each electrode on a biweekly basis. The distance of electrodes from the retinal surface and retinal thickness were measured by optical coherence tomography on a less regular basis. RESULTS Stimulation thresholds for detecting phosphenes correlated with the distance of the electrodes from the retinal surface, but not with electrode size, electrode impedance, or retinal thickness. CONCLUSIONS Maintaining close proximity between the electrode array and the retinal surface is critical in developing a successful retinal implant. With the development of chronic electrode arrays that are stable and flush on the retinal surface, it is likely that the influence of other factors such as electrode size, retinal degeneration, and subject age will become more apparent. (ClinicalTrials.gov number, NCT00279500.
author_names: Chloe de Balthasar

Sweta Patel

Arup Roy

Ricardo Freda

Scott H Greenwald

Alan Horsager

Manjunatha Mahadevappa

Douglas Yanai

Matthew J Mcmahon

Mark S Humayun

Robert J Greenberg

James D Weiland

Ione Fine
title: Factors affecting perceptual thresholds in epiretinal prostheses.
venue: Investigative ophthalmology visual science
year: 2008

abstract: The Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre, randomised controlled trial: design and methodology (see page 593) The Laser in Glaucoma and Ocular Hypertension trial is a multicentre randomised controlled trial investigating the health related quality of life, clinical and cost effectiveness of drops versus selective laser trabeculoplasty as a first line treatment.
author_names: Keith Barton

James Chodosh

Jost Bruno Jonas
title: Highlights from this issue
venue: British Journal of Ophthalmology
year: 2018

abstract: PURPOSE To determine the incidence and baseline clinical and anterior segment optical coherence tomography (AS OCT) predictors associated with residual angle closure as assessed by gonioscopy 1 year after laser peripheral iridotomy (LPI) in primary angle closure suspects (PACS) DESIGN Subanalysis of randomized controlled trial data. METHODS AS OCT images from 181 PACS subjects =50 years of age were analyzed using customized software before and 1 year after LPI. Other parameters assessed were intraocular pressure (IOP) and axial length (Axl) Residual angle closure was defined as the inability to see the posterior trabecular meshwork for at least 2 quadrants on gonioscopy after LPI. Multivariate regression analysis determined the baseline predictors of residual angle closure 1 year after LPI. RESULTS The mean age of participants was 62.4 (standard deviation 9.9) years. The majority were female (137, 75.7% and Chinese (174, 96.1% At 1 year post LPI, 148 (81.8% subjects had gonioscopic residual angle closure. Univariate analysis showed that baseline Axl, anterior chamber area, anterior chamber volume, angle opening distance at 750 mm from the scleral spur, and angle recess area were smaller while baseline lens vault and iris curvature were larger in residual angle closure subjects (all P .05) Multivariate analysis revealed that baseline iris volume (B 0.08, P .035) and baseline IOP (B 0.23, P .032) were predictors for residual angle closure. CONCLUSIONS One year after LPI, >80% of PACS had gonioscopic residual angle closure. Greater baseline iris volume and higher IOP at baseline are independent risk factors for residual gonioscopic angle closure.
author_names: Mani Baskaran

Elizabeth Yang

Sameer Trikha

Rajesh Kumar

Hon-Tym Wong

Mingguang He

Paul T K Chew

Paul J Foster

David S Friedman

Tin Aung
title: Residual Angle Closure One Year After Laser Peripheral Iridotomy in Primary Angle Closure Suspects.
venue: American journal of ophthalmology
year: 2017

abstract: Proliferative vitreoretinopathy remains the most frequent cause of failure of retinal detachment repair. The manuscript by Bannerjee et al, "Slow Release Dexamethasone in Proliferative Vitreoretinopathy: A Prospective Randomized Controlled Clinical Trial," (see p. 757) presents an important study searching for an effective therapy in eyes with retinal detachment associated with proliferative vitreoretinopathy (PVR) Many prior pharmacologic treatments have been tried, including the use of daunorubicin, 5 fluorouracil combined with low molecular weight heparin, colchicine, 13 cis retinoic acid, triamcinolone, and systemic steroids. The authors are to be congratulated for submitting this study because it reports negative results. Studies with statistically significant results are 3 times more likely to be published than studies where the results do not reach statistical significance. The publication of studies with negative results is very important because this information is useful in designing other studies attempting
author_names: John T Thompson
title: Negative Results Matter: Why Can't We Improve the Treatment of Proliferative Vitreoretinopathy?
venue: Ophthalmology
year: 2017

abstract: The role of internal limiting membrane peeling in epiretinal membrane surgery: a randomized controlled trial (see page 719) This two centre, randomised, controlled clinical trial compared the anatomical and functional outcomes after primary idiopathic epiretinal membrane peeling with or without internal limiting membrane peeling. The result suggests that ILM peeling in ERM surgery does not improve visual outcome at 12 months.
author_names: Keith Barton

James Chodosh

Jost Bruno Jonas
title: Highlights from this issue
venue: British Journal of Ophthalmology
year: 2017

abstract: The Macular Photocoagulation Study (MPS) is a multicenter, collaborative, clinical trial that provides important guidelines for the treatment of choroidal neovascularization from age related macular degeneration (AMD) presumed ocular histoplasmosis syndrome (POHS) and idiopathic neovascularization. In a previous editorial, Jampol 1 discussed the role of hypertension among patients in the MPS, showing that under some circumstances, patients with hypertension had a less beneficial response to laser photocoagulation. Another aspect of the MPS that has received almost no attention to date is the racial characteristics of patients enrolled in the trial. See also p 1701. The MPS includes three clinical trials for AMD: argon laser photocoagulation for extrafoveal membranes, krypton laser photocoagulation for juxtafoveal membranes, and argon or krypton laser photocoagulation for subfoveal membranes. As of July 1,1991, a total of 1319 patients had been enrolled in these trials (Maureen Maguire, PhD, written communication) Of these patients, 1314 were white, one was black, and
author_names: Lee Merrill Jampol

James M Tielsch
title: Race, macular degeneration, and the Macular Photocoagulation Study.
venue: Archives of ophthalmology
year: 1992

abstract: These words conclude the report of a clinical trial published in this issue of theArchivesthat was designed to evaluate the effects of nutritional supplements of vitamins A and E on the natural course of retinitis pigmentosa. This study is a tour de force in experimental design, execution, and statistical analysis. The investigators deserve congratulations on the successful completion of this ambitious, rigorous, and interesting study. See also pp 754 and 761. Retinitis pigmentosa can be a devastating disease for the patient who suffers night blindness, progressive visual field loss, and eventually loss of central vision. There is no cure for retinitis pigmentosa, and patients are in constant search of hope. Therefore, when interpreting the intriguing results of this clinical trial, it is important to use caution and to avoid drawing unwarranted conclusions that could lead to unreasonable expectations by patients. Despite our admiration of the design and execution
author_names: Robert W Massof

Daniel Finkelstein
title: Supplemental vitamin A retards loss of ERG amplitude in retinitis pigmentosa.
venue: Archives of ophthalmology
year: 1993