Treatment Trials

8 Clinical Trials for Various Conditions

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ACTIVE_NOT_RECRUITING
Photorefractive Keratectomy for Severe Anisometropia and Isoametropia Associated With Amblyopia
Description

Photorefractive keratectomy (PRK) with excimer laser has been used successfully to treat myopia, hyperopia, and astigmatism in adults for over 35 years. Children with high refractive errors that go untreated will develop severe amblyopia. PRK can normalize high refractive errors and potentially improve the visual acuity in affected children. The purpose of this study is to investigate whether children with high anisometropia or isoametropia with amblyopia that are nonresponsive to standard therapy and receive PRK develop better longterm visual acuity.

COMPLETED
LFR-260 vs Traditional Phoropter in Visual Acuity Testing
Description

The purpose of this study is to establish if LFR-260 (investigational device) is not inferior in effectiveness to a traditional phoropter (control device) when applied in visual acuity test in subjects undergoing a full routine eye examination. LFR-260 proposes to provide information of the visual capabilities of the patient. The test will be provided and supervised by a qualified eye care provider. The informed consent, screening, randomization (into the order of visual test device used), (visual) device testing (to include precision testing, remote and offsite testing) will all occur at a single visit.

COMPLETED
Enhanced Housing Photoscreeners 2WIN and GoCheckKids Compared in Burma and Alaska
Description

"Adaptica" (Padova, Italy) designed a fixed-distance, dark portable tube with power and remote control for the "2WIN: photoscreener. GoChecksKids designed a flash-concentrating case for the iPhone 7+ to more quickly achieve two-axis photoscreen. These devices were compared to confirmatory exams in children and young adults in a remote Burma clinic and in an Alaskan pediatric ophthalmology practice.

TERMINATED
Dichoptic Virtual Reality Therapy for Amblyopia in Adults
Description

This was a randomized, masked, controlled study of the effect of a virtual reality, binocular, 3-dimensional video game on visual acuity and stereopsis in adult patients with amblyopia. The trial has been halted as of June 2016 and will not be evaluating any new subjects for enrollment.

COMPLETED
Amblyopia (Lazy Eye) Treatment Study
Description

The purpose of this study is to compare the results of two standard treatments for amblyopia in order to find out if one is more effective than the other. Amblyopia, which develops in childhood, is also called "lazy eye," because one eye is not being used properly. The brain favors the other eye for some reason, such as crossing or turning out of the eyes, and vision in the weak eye is reduced. Amblyopia is treated by forcing the child to use the weak eye. There are two ways to do this: 1) a patch placed over the "good" eye forces the child to use the weak eye; or 2) an eye drop placed in the "good" eye once a day to blur vision in that eye makes the child rely on the weak eye. The success rates with both of these methods have been reported to be about the same; this study will try to identify if one is more effective than the other. Children will be randomly assigned by computer to one of the following two treatment methods: Patch The child initially will wear a patch over the "good" eye for 8 to 12 hours every day. If vision in the weak eye improves, the patching time will be decreased. If vision remains good after 3 months, the patching will be stopped, unless the child's doctor believes treatment should continue. If vision in the weak eye does not improve, the patching time will be increased. Eye Drops The child will be given one drop per day of atropine in the "good" eye. If vision in the weak eye improves, the drops will be given less often. If the vision remains good after 3 months, the drops will be stopped, unless the child's doctor believes treatment should continue. If the initial daily drop does not improve the vision in the weak eye, the child's eyeglasses may be changed to try to further blur the vision in the "good" eye. After 6 months, treatment may be stopped if it has not been successful. If treatment has been successful after 6 months, it may be continued at a reduced amount or stopped. Follow-up visits will be scheduled every 4 weeks for the first 6 months and every 2 to 4 months after that until the end of the 2-year study. During each visit the eyes will be examined for eye movements and vision, and the pupils will be dilated to examine the inside of the eye.

UNKNOWN
Light-deprivation Utilized to Mitigate Amblyopia
Description

Amblyopia is an impairment in spatial vision caused by asymmetry in the quality of visual input across the two eyes during childhood. It is difficult to treat in adulthood because the visual system becomes less "plastic" (able to learn) with age. The purpose of this study is to determine whether five to ten days of visual deprivation--living in complete darkness--can enhance plasticity in the visual cortex and thereby facilitate the learning that is needed to recover visual function in amblyopic adults.

Conditions
COMPLETED
Visual Cortex Stimulation in Patients With Amblyopia
Description

This study will examine whether direct current (DC) polarization (electrical stimulation) of the visual cortex can cause a temporary improvement of vision in an amblyopic eye of an adult. Amblyopia (also called lazy eye) is reduced vision in an eye, caused by abnormal brain processing of visual information. In amblyopia, the visual cortex (the part of the brain that processes visual information) favors the other eye and suppresses the image from the amblyopic eye. Amblyopia in children is treated by patching or blurring the good eye, which forces the child to use the amblyopic eye and overcome suppression by the brain. This treatment only works in children 8 years old and younger, however. Electrical stimulation of the brain can temporarily change the function of the visual cortex in adults with good vision, but its influence on the visual function of people with amblyopia is unknown. If DC polarization can improve vision in amblyopic eyes in adults, it would show that the visual cortex is still plastic, and it might help researchers develop a treatment for adults with amblyopia in the future. Patients 18 years of age and older with amblyopia caused by crossing in or turning out of the eyes in childhood or by a difference in near- or farsightedness between the eyes may be eligible for this study. Candidates are screened with a medical history and complete eye examination, including a glaucoma screening and checks of vision, in- or out-turning of the eyes, depth perception, need for glasses, and the interior structures of the eyes. Participants undergo two study sessions, scheduled at least 24 hours apart, involving the following procedures: * Examination: Before each session, the patients' distance vision, contrast sensitivity (ability to see fading letters), and ability to read small print are checked in both eyes. * DC polarization: Patients receive either 20 minutes of electrical stimulation or 20 minutes of sham stimulation (each patient will receive both electrical and sham stimulation on different days). * Repeat examination: Immediately after the stimulation and again 20 minutes later, patients undergo repeat visual function testing. Those who show any differences in visual function 20 minutes after the stimulation are examined again 1 hour after the stimulation. Patients in whom the effect continues after 1 hour are examined again after 1 week.

RECRUITING
Treating Amblyopia With CureSight
Description

Patients with visual acuity and ocular characteristics outside the Novasight FDA multi-center study are to perform the same Curesight procedures- including M\&S EVA or eETDRS patched acuity, stereo and then utilize the Curesight device 1.5 hours per day, 6 days per week over 3-6 months to determine treatment efficacy. An Eye-Tracking-Based Dichoptic Home Treatment for Amblyopia: A Multicenter Randomized Clinical Trial T. Wygnanski-Jaffe, B. J. Kushner, A. Moshkovitz, M. Belkin, O. Yehezkel and G. CureSight Pivotal Trial Ophthalmology 2023 Vol. 130 Issue 3 Pages 274-285

Conditions