Clinical Trials

• Bangerter Filters versus Daily Patching for the Treatment of Moderate Amblyopia in Children
  The purpose of this study is to compare treatment of moderate amblyopia in children. The treatment of amblyopia involves making the child use the eye with the worse vision ("weak eye"). This is most often done either by having the child wear a patch over the "good" eye or by putting an eye drop called atropine in the good eye to blur the vision. Amblyopia can also be treated by putting a piece of plastic, called a Bangerter filter, on the glasses lens in front of the good eye. It is not known if the filter works as well as a patch, which is what this study aims to determine.The National Eye Institute is providing the funding for the study.
  

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• Comparison of Keratoplasty Techniques for Corneal Endothelial Decompensation
  This study is being done to compare the outcomes of different corneal transplantation techniques. Specifically, we wish to compare which technique results in better vision, faster visual recovery, and longer transplanted cell survival. The surgical techniques to be compared are DLEK (deep lamellar endothelial keratoplasty), DSEK (Descemet stripping with endothelial keratoplasty), and PK (penetrating keratoplasty).
  

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• Convergence Insufficiency Treatment Trial
  The purpose of the Convergence Insufficiency Treatment Trial (CITT) is to compare treatments for an eye-teaming problem called convergence insufficiency in order to compare commonly used treatments. The research study is conducted at several institutions across the United States and is supported by a grant from the National Eye Institute, National Institutes of Health, and the Department of Health and Human Services. Approximately 208 patients will be entered into the study and cared for by participating eye doctors.
  

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• CRVO Regeneron
  Intravitreal injection of the VEGF Trap for patients with macular edema due to CRVO will not be better than placebo.
  

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• Daily Patching Plus Daily Atropine for Residual Amblyopia in Children
  The purpose of this study is to determine the best treatment of amblyopia, or "lazy eye." The treatment of amblyopia involves making the child use the eye with the reduced vision ('weak eye'). This is often done by having a child wear a patch over the 'good' eye. It is also done by putting an eye drop called atropine in the good eye to blur the vision. Although vision usually improves with treatment, many children do not reach normal vision. When the vision stops improving with one of these treatments, some eye doctors decrease the treatment and then stop it completely. Other doctors try methods such as using both a patch and the eye drop at the same time. We are seeking to determine if this combined treatment will improve vision.A grant from the National Eye Institute is funding the study.
  

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• Mapping Novel Genes for Fuchs' Endothelial Corneal Dystrophy
  This study is being done to collect information from Fuchs' Endothelial Corneal Dystrophy (FECD) patients and their family members so that researchers can explore the genetic likelihood that would cause a person to develop FECD.The National Eye Institute (NEI) is funding the study.
  

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• Observation Versus Occlusion Therapy for Intermittent Exotropia
  Intermittent exotropia (IXT) is the most common form of childhood-onset exotropia with an incidence of 32.1 per 100,000 in children under 19 years of age. Intermittent exotropia is characterized by an exotropia that is not constant and is mainly present in the distance but may also be present at near. Many cases of IXT are treated using non-surgical interventions, such as part-time occlusion, fusional vergence exercises, and over-minus lenses. The rationale for such interventions is that they may improve the ability to control the IXT and preserve stereoacuity, thereby potentially addressing both visual function and social concerns, and may delay or eliminate the need for surgical correction of IXT. Nevertheless, the natural history of IXT is unknown and in many cases it is not known whether withholding treatment may in fact allow for spontaneous resolution or improvement in IXT, making non-surgical or surgical intervention unnecessary. Moreover, although non-surgical treatments for IXT are commonly prescribed, such treatments have not been subjected to rigorous study and their efficacy in improving visual function or social concerns remains unclear. One aim of the present study is to better understand the natural history of IXT. Available reports on the natural history of IXT disagree on the progression of the disease. A 1966 study by von Noorden (cited in von Noorden and Campos) found that over an average of 3.5 years of follow-up, 75% of 51 patients showed signs of IXT progression, 9% showed no change, and 16% improved without therapy. A 1968 retrospective study by Hiles et al found that after a minimum of 6 years follow up with observation and nonsurgical treatment, 81% of 48 patients showed no change in angle of deviation. The results of more recent retrospective studies show some reporting that the majority of cases improve over time, others reporting that most cases remain stable, and still others reporting that most cases deteriorate. It is therefore unclear what proportion of patients, if left untreated, is likely to deteriorate, improve, or remain stable over time. Natural history data acquired during this study will help determine not only what proportion of patients change over time, but whether there are associated prognostic indicators of deterioration or improvement. Such data will not only enable better identification of those patients with IXT likely to benefit from treatment and those for whom treatment is likely to be unnecessary, but will also improve the quality of medical advice to parents regarding the likely progression of the disease, thus alleviating anxiety. The aim of most forms of non-surgical treatments for IXT is to improve the strength and/or quality of binocular single vision by either eliminating suppression, increasing awareness of diplopia, and/or increasing positive fusional amplitudes. Commonly used non-surgical treatment methods include: occlusion, fusional vergence exercises (sometimes known as vision therapy or orthoptics), and over-minus lenses. When surveyed in 1990, members of the American Association for Pediatric Ophthalmology and Strabismus reported that occlusion was the most commonly used form of non-surgical treatment. More recently (2008), a poll of our investigator group revealed again that occlusion was the most widely prescribed non-surgical treatment for children affected by IXT. Occlusion is thought to work by interrupting the development of or eliminating already present suppression, an adaptation to avoid diplopia in IXT. Persistent or entrenched suppression prevents normal binocular vision and may lead to permanent loss of stereoacuity. If successful, occlusion may then result in improved binocular sensory fusion. As reported in recent reviews of treatment for IXT, previous studies of occlusion vary regarding the recommended occlusion dose (from 3 hours a day to full time), the optimum duration of occlusion treatment (from 6 weeks to 42 months), and which eye should be occluded (preferred/dominant eye or alternate eyes). For the majority of studies, part-time occlusion, rather than full-time occlusion was preferred. In the three occlusion studies conducted prospectively, the recommended dose was either 3 hours a day, 3 to 6 hours a day, or 4 to 6 hours a day, and the duration of occlusion ranged from 3 months to 6 months to up to 42 (mean 15) months. Nevertheless, these previous studies of occlusion for the treatment of IXT used a variety of outcome measures at a variety of non-standardized time points; therefore, no definite conclusions can be drawn from the existing literature. Although occlusion treatment for IXT treatment is widely used, there have been no randomized clinical trials evaluating its effectiveness. Understanding the degree of effectiveness of occlusion treatment for IXT and the natural history of IXT has important public health implications. Successful restoration of binocular alignment and normal binocular function with occlusion therapy, or spontaneous improvement, will reduce the proportion of children undergoing surgery. Defining the rate of success with either occlusion or observation is therefore important in planning treatment for children with IXT. Alternatively, evidence of low treatment effectiveness with occlusion will help avoid unnecessary treatment. The present study is being conducted to assess the natural history of IXT and to establish the effectiveness of occlusion in its treatment.
  

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• Quality of Life in Childhood Strabismus
  A brief questionnaire for the child and one for the parent explores the difficulties in dealing with Intermittent Exotropia, an out turning eye. The information will be helpful for assessing the full implact of this condition on children and their parents.
  

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• The Age-Related Eye Disease Study 2 (AREDS2)
  This study is being done to learn what role nutritional pills with lutein and zeaxanthin and/or omega-3 long-chain polyunsaturated fatty acids, specifically docosahexaenoic acid (DHA) and icosapentaenoic acid (EPA), play in preventing or slowing the development of age-related macular degeneration (AMD) and cataract.This study is supported by the National Eye Institute, part of the federal government's National Institutes of Health.
  

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• Treatment Algorithms for Pigment Epithelial Detachments Treated with Intraocular Lucentis
  The purpose of this study is to determine if there is a benefit to visual acuity (the sharpness of vision) with continued treatment of wet age-related macular degeneration (AMD) until retinal pigment epithelial detachment (RPED) fully resolves, to determine how long it takes for the swelling in the retina and then RPED to flatten following the initiation of Lucentis therapy, and to determine how long these improvements last after the last treatment. The study drug being tested blocks a substance (vascular endothelial growth factor) that is thought to promote the formation of abnormal blood vessels responsible for loss of vision in subjects with wet AMD.
  

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