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A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age (ATS23)
Rochester, Minn.
In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks.
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A Randomized Trial to Evaluate Sequential vs Simultaneous Spectacles plus Patching for Amblyopia in Children 3 to < 13 Years Old (ATS22)
Rochester, Minn.
The purpose of this study is to determine whether simultaneous treatment with spectacles and patching has an equivalent VA outcome compared with sequential treatment, first with spectacles alone, followed by patching (if needed), for previously untreated amblyopia in children 3 to < 13 years of age.
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Clinical Study of the ARTISAN Aphakia Lens for the Correction of Aphakia in Children
Rochester, Minn.
To determine the effectiveness of the ARTISAN Aphakia lens in the treatment of aphakia and to precisely define the associated risks and, if possible, identify particular groups of patients who may be at high risk of developing complications resulting from the surgical procedure of implanting an ARTISAN Aphakia lens.
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Evaluating Patient Reported Outcome Measures in Children with Eye Conditions (PedEyeQ)
Rochester, Minn.
The objectives of this study are:
- To evaluate patient-reported quality of life and functional vision across the spectrum of pediatric eye conditions;
- To assess change in patient-reported quality of life and functional vision over time;
- To compare the impact of different treatments on quality of life and functional vision;
- To assess change in patient-reported quality of life and functional vision in response to treatment;
- To determine associations between quality of life / functional vision scores and specific clinical and demographic characteristics.
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Home Visual Acuity Testing (X06)
Rochester, Minn.
Management of most pediatric eye conditions requires periodic monitoring of visual acuity (VA).
In many cases, particularly the treatment of amblyopia, measurement of VA is the key clinical
outcome of the clinical examination done in the office. However, transporting children and
teenagers to and from the care provider’s office to obtain follow-up measurements of VA can be
difficult due to the need to take time off work and school. In addition, transportation can be a
barrier because of access or cost or both. Additionally, the recent emergence of the COVID-19
pandemic and subsequent global “shelter in place” and “lockdown” precautions have further
highlighted the need for a validated method of measuring VA at home, to enable the monitoring
of eye conditions in the context of telemedicine.
The present study is designed to evaluate whether VA measured at home by a parent or guardian
using the age appropriate ATS-HOTV or e-ETDRS testing protocol on an iPhone-based
application (hereafter referred to as “phone-based” method) will result in measurements similar to
those collected during an office visit at an eye clinic using the same testing protocol on a study
certified EVA or M&S visual acuity tester (hereafter referred to as “office-based” method).
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IXT7:Randomized Trial of Full-Time Occlusion Therapy for Intermittent Exotropia in Children (IXT7)
Rochester, Minn.
The purpose of this study is to determine whether full-time patching is more effective than observation for improving distance control of Intermittent Exotropia (IXT) after 3 months of treatment (ontreatment outcome).
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Closed for Enrollment
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A Prospective Observational Study of Adult Strabismus (SAS1)
Rochester, Minn.
The purpose of this study is to describe clinical characteristics, treatments, and one-year outcomes for adults who have convergence insufficiency, divergence insufficiency, or small angle hypertropia.
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A Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia (IXT5)
Rochester, Minn.
The main objectives of this randomized trial comparing overminus lens treatment to non-overminus (spectacles without overminus or spectacles with plano lenses) are to determine: - The long-term on-treatment effect of overminus treatment on distance IXT control score. - The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment).
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A Randomized Trial of Bilateral Lateral Rectus Recession Versus Unilateral Lateral Rectus Recession With Medial Rectus Resection for Intermittent Exotropia (IXT1)
Rochester, Minn.
The purpose of this study is to evaluate the effectiveness of bilateral lateral rectus muscle recession versus unilateral lateral rectus recession with medial rectus resection procedures for the treatment of basic type and pseudo divergence excess type intermittent exotropia.
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A Randomized, Parallel-arm, Active Control, Multicenter Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
Rochester, Minn.
The purpose of this study is to assess the safety of Dextenza compared to an active control, prednisolone acetate suspension, for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract.
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Augmenting Patching Treatment for Amblyopia with Physical Exercise
Rochester, Minn.
The purpose of this study is to establish whether moderate physical exercise enhances treatment benefit when patching 2 hours a day for residual amblyopia in children.
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Binocular Dig Rush Game Treatment for Amblyopia (ATS20)
Rochester, Minn.
The purpose of the study is to compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to <13 years of age.
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GLASSES VERSUS OBSERVATION FOR MODERATE HYPEROPIA IN YOUNG CHILDREN (HTS1)
Rochester, Minn.
Some doctors feel that a child with hyperopia (farsightedness) should have glasses before any potential vision problems (such as amblyopia or strabismus) develop. Other doctors feel that children should not be given glasses unless vision problems occur. It is not known if hyperopia should be treated immediately or only if other problems occur. This is the reason this randomized clinical trial is being done.
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Intermittent Exotropia Study 6: A Pilot Randomized Clinical Trial of Base-in Prism Spectacles for Intermittent Exotropia (IXT6)
Rochester, Minn.
The purpose of this study is to compare spectacles with relieving prism to spectacles without prism to determine whether to proceed to a full-scale, longer-term randomized trial. This decision will be based primarily on assessing the initial (8-week) response to prism by comparing treatment groups on the following outcomes:
- Mean distance intermittent exotropia (IXT) control score (the mean of 3 control scores) (primary outcome);
- The proportion of participants demonstrating a "treatment response," defined as ≥ 1 point improvement in the mean distance IXT control score without spontaneous exotropia during control testing (secondary outcome);
- The proportion of participants reporting adverse effects and good/excellent spectacle wear compliance.
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Outcome Measures for Clinical Trials in Pediatric Eye Care and Strabismus
Rochester, Minn.
This study is being done to:
- Assess what children with different eye conditions experience in everyday life
- Improve our understanding of the difficulties that children with eye problems experience
- Improve reporting of how parents see their child’s eye condition affecting them
- Assess what parents of children with different eye conditions experience in their own everyday life
- Improve the way we assess the benefits of treatment
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Pediatric Cataract Surgery Outcomes Registry
Rochester, Minn.
This study is being done to learn about cataract surgery in children. The study involves the collection of information about children who have had cataract surgery. This information will include when the child developed cataract, how the cataract has been treated, problems that may have occurred related to surgery, and whether anyone else in the family has had a cataract. Doctors throughout the United States and possibly other parts of the world are taking part in the study. We hope that gathering the information from many children we can improve the care of children with cataracts.
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Pediatric Optic Neuritis Prospective Outcomes Study (PON1) (PON1)
Rochester, Minn.
The primary outcome is visual acuity at 6 months. Secondary aims will be to characterize optic neuritis in a large multicenter cohort of children and to assess the risk of development of MS at two years.
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Signs and Symptoms of Retinal Disease
Rochester, Minn.
The aim of this study is to determine which clinical characteristics are associated with diplopia in patients with epiretinal membranes.
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Treating Amblyopia in Adults with Interactive Video Games
Rochester, Minn.
The purpose of this study is to establish whether or not interactive video game play provides a means of treating amblyopia in adults.
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