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Amblyopia clinical trials

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NCT ID: NCT00669539 Completed - Amblyopia Clinical Trials

Observational Study of Optical Correction for Strabismic Amblyopia in Children 3 to <7 Years Old

ATS13
Start date: May 2008
Phase: N/A
Study type: Observational

This study will evaluate the effectiveness of refractive correction alone for the treatment of previously untreated strabismic or combined-mechanism amblyopia in children 3 to <7 years old with visual acuity of 20/40 to 20/400

NCT ID: NCT00587171 Terminated - Amblyopia Clinical Trials

Trial Comparing Patching With Active Vision Therapy to Patching With Control Vision Therapy as Treatment for Amblyopia

ATS12
Start date: April 2008
Phase: Phase 3
Study type: Interventional

This study is comparing the effectiveness of patching combined with active vision therapy plus near activities versus patching combined with control vision therapy plus near activities for moderate amblyopia (20/40-20/100) in 7 to <13 year olds. The primary outcome measure is the proportion of patients with visual acuity of 20/25 or better in the amblyopic eye at the 17-week masked exam. These patients will be considered treatment responders. The primary analysis will consist of a comparison between the 2 treatment groups of the proportion of treatment responders with adjustment for baseline visual acuity. Secondary outcomes are stereoacuity at the 17-week masked exam, mean improvement in visual acuity at the 17-week masked exam, and rate of improvement of visual acuity.

NCT ID: NCT00525174 Completed - Amblyopia Clinical Trials

Full-time Bangerter Filters Versus Part-time Daily Patching for Moderate Amblyopia in Children

ATS10
Start date: November 2007
Phase: Phase 3
Study type: Interventional

This study is a randomized clinical trial designed to evaluate the non-inferiority of Bangerter filters compared to 2 hours of daily patching as a primary treatment for moderate amblyopia (20/40 to 20/80) in children ages 3 to < 10 years. Secondary objectives of this study are (1) to determine the time course of visual improvement with Bangerter filter treatment, (2) to compare patient quality of life, measured by a modified Amblyopia Treatment Index, between patients treated with patching vs. Bangerter filters, (3) to determine whether blurring the sound eye to a visual acuity worse than the amblyopic eye predicts improvement in acuity, and (4) to determine whether a change in fixation to the amblyopic eye is predictive of improvement in visual acuity. The primary outcome assessment is visual acuity at 24 weeks for both the amblyopic and sound eyes. The primary analytic approach for the amblyopic eye acuity will involve construction of a one-sided 95% confidence interval to assess non-inferiority based on a treatment group comparison of logMAR visual acuity scores adjusted for baseline visual acuity scores in an analysis of covariance (ANCOVA) model. Sound eye acuity data will be reported for each treatment regimen at the 24-week visit as mean change (logMAR lines) from baseline and as the distribution of the number of lines of change from baseline.

NCT ID: NCT00506675 Terminated - Amblyopia Clinical Trials

Combined Patching-Atropine for Residual Amblyopia

ATS11
Start date: October 2007
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the effectiveness of treatment of residual amblyopia in children ages 3 to < 10 years with visual acuity of 20/32 to 20/63 in the amblyopic eye. The study is a randomized clinical trial comparing intensive treatment (42 hours per week of patching plus daily atropine) with a control group that will have rapid weaning of existing treatment followed by spectacle correction only (if needed). The primary objective is to determine if this intensive treatment will improve visual acuity in patients with residual amblyopia. The primary outcome assessment is amblyopic eye visual acuity at 10 weeks. The primary analytic approach for the amblyopic eye acuity will be a treatment group comparison of the proportion of patients with at least two lines of visual acuity improvement.

NCT ID: NCT00315328 Completed - Amblyopia Clinical Trials

Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds

ATS9
Start date: August 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is: - To compare the effectiveness of weekend atropine plus near activities and daily patching plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia (20/125 to 20/400) in improving vision in the amblyopic eye of 7 to <13 year olds. - To determine the maximum improvement in vision of the amblyopic eye with each treatment. - To determine whether amblyopia is associated with structural abnormalities of optic nerve fiber layer.

NCT ID: NCT00315302 Completed - Amblyopia Clinical Trials

Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old

ATS8
Start date: February 2005
Phase: Phase 3
Study type: Interventional

The purpose of the study is: - To compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to less than 7 years old. - To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine treatment with and without a plano lens.

NCT ID: NCT00315198 Completed - Amblyopia Clinical Trials

Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old

ATS6
Start date: February 2005
Phase: Phase 3
Study type: Interventional

Ths purpose of this study is to determine whether "near" activities enhance the effect of patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared with "distance" activities in the treatment of moderate amblyopia and severe amblyopia in children 3 to <7 years old.

NCT ID: NCT00312390 Withdrawn - Amblyopia Clinical Trials

Amblyopia and Neurovascular Coupling in the Retina of Humans

Start date: July 2003
Phase: N/A
Study type: Interventional

The visual disorder of amblyopia affects 2% to 3% of the population. Amblyopia is a developmental condition that is characterized by reduced vision of the eye due to the presence of a sensory impediment during visual development, such as strabismus (ocular misalignment) or anisometropia (unequal refractive error), occurring early in life. Recent studies in humans and animals point towards a cortical locus for the processing deficit in amblyopia, revealing sensory deficits at the signal cell level that include reduced spatial resolution, reduced contrast sensitivity, and a reduced number of binocular neural cells. In the retina, however, no abnormalities have yet been reported. Like in the brain blood flow in the retina is coupled to neuronal activity. This phenomenon has been measured by different study groups with non invasive techniques in the brain and retina. We therefore use a Zeiss fundus camera for the assessment of retinal vessel diameters. This so called retinal vessel analyzer (RVA) is a combination of a fundus camera connected to a high resolution video camera equipped with a software based analyzing system. An unprecedented reproducibility and sensitivity of retinal vessel diameter measurements is attained with this system. In addition this system allows real time analysis of retinal vessels as well as off-line determinations from video tape. A special provocation test, which minimizes risk and discomfort to the subject under study is applied through the illumination pathway of the fundus camera: Diffuse luminance flicker is used as a stimulus to augment intrinsic mechanisms by which the retina can vary the vascular supply, in correspondence with local variations of functional activity. This system allows to study the flicker response of retinal vessels, which is within a magnitude of 6 to 8%. However, the exact mechanisms underlying this phenomenon are not fully understood. Especially in the eye it is not clear whether it is an exclusive metabolic effect within the retina and the surrounding blood vessels or dependent of central regulatory brain functions. The purpose of the current study is to improve our understanding of the mechanisms underlying flicker evoked responses of retinal blood vessels in humans. It is not clear whether the retina of amblyopic eyes can regulate retinal blood flow in response to increased metabolic demands as induced during flicking light stimulation. A detail understanding of the metabolic and functional processes within the retina of patients with amblyopia is a prerequisite for further research to prevent amblyopia.

NCT ID: NCT00305955 Completed - Clinical trials for Bilateral Refractive Amblyopia

Bilateral Refractive Amblyopia Treatment Study

ATS7
Start date: August 2004
Phase: Phase 3
Study type: Observational

The purpose of this study will be to: - Determine the amount of visual acuity improvement with treatment of presumed bilateral refractive amblyopia - Determine the time course of visual acuity improvement with treatment

NCT ID: NCT00274664 Completed - Amblyopia Clinical Trials

Patching for Lazy Eye: Trial to Evaluate Daily Patching Amounts

Start date: February 2002
Phase: Phase 1
Study type: Interventional

Amblyopia (‘lazy eye’) is the commonest visual disorder of childhood and is caused by an interruption to visual development. Occlusion of the better eye by patching is the mainstay of treatment, so forcing use, of the affected eye. We have little understanding of how much treatment is required for improvement, so occlusion may continue for many months. This is both demanding for the child and family as a whole. Treatment outcome is frequently unsatisfactory. Compliance is often poor, thus we do not know precisely how much treatment the child actually receives or how much is required. To overcome this, we have designed an instrument that permits us to measure occlusion: an occlusion dose monitor (ODM) which provides an objective record of how much occlusion a child actually receives. Recently we have observed that 75% of improvement induced by occlusion occurs in the first four weeks of treatment. In this study we explore the possibility that by intensive treatment the period of amblyopia therapy can be shortened – i.e. treatment will be more efficient, more effective, and more ‘family-friendly’. The study hypothesis is that 12 hours/day of patching is more effective than 6 hours/day.