View clinical trials related to Amblyopia.
Filter by:Amblyopia is the most common developmental vision disorder in children, caused by abnormal visual experience in early life, especially a difference in refraction between the eyes, a misalignment of the eye axes, a combination of both. Besides a significant reduced visual acuity, the patients show deficits in 3D vision and functional vision impairment like reduced reading speed, selective attention or motor control skills. The gold standard treatment for amblyopia, occlusion therapy, can lead to relapses or residual amblyopia (i.e., amblyopia that persist into adulthood). The current study aims to test the efficacy of a novel home-based child-friendly rehabilitation program for amblyopia, Vivid Vision Home, involving playing serious videogames on a virtual reality (VR) headset at home. The VR training will be compared to standard care (wearing a spectacle correction) and to age-matched typically developing individuals. A cross-over design will be used so that each participant will receive both treatments (games, spectacles). There is a growing number of studies showing benefits of binocular stimulation for visual acuity and stereovision, but provided mainly by level III studies, with a need for rigorous level I or II studies, using more engaging therapies, to confirm or refute the efficacy of this approach as an adjunct or replacement for current amblyopia treatments. Embedding binocular stimulation in engaging, immersive serious games delivered on VR headsets at home, as implemented by Vivid Vision Home, can address this question.
An Eye-Tracking-Based Binocular Amblyopia Technology Improves Both Visual Acuity and Binocularity Screening A child is considered for the study after undergoing a standard of care and study-specific eye examinations (by a study investigator as part of the standard of care) that identify amblyopia appearing to meet the eligibility criteria. The study will be discussed with the child's parent(s) or guardian(s) (referred to subsequently as parent (s)). Parent(s) who express an interest in the study will be given a copy of the informed consent form to read. Written informed consent must be obtained from a parent and child prior to performing any study-specific procedures that are not part of the child's routine care. On screening visit, eligibility assessment, medical history, Demographic data, Refraction and Cycloplegia, Demonstration suitability using the CureSight, ATS Diplopia Questionnaire, Symptom Survey Distance VA Testing, Ocular Alignment Testing, Near VA Testing, Stereoacuity Testing- Titmus Fly, Eye movement exams (optional), Contrast sensitivity (optional), Reading rest (optional). All eligible subjects enrolled in the study will be followed for 24 weeks of training followed by 52 weeks of follow-up. 24 weeks: Binocular treatment 90 minutes per day, 5 days per week for 12 weeks followed by 90 minutes per day, 3 days per week for an additional 12 weeks Follow up visits - Visit 1: 4 weeks ± 1 week - Visit 2: 8 weeks ± 1 week - Visit 3: 12 weeks ± 1 week - Visit 4: 24 weeks ± 1 week (primary endpoint) - Optional Visit 5: 52 weeks ± 1 week (exploratory outcome, including retainment of improvement; and additional exploratory outcomes)
A prospective interventional study is expected to be conducted, to test a possible new treatment for amblyopia (lazy eye syndrome). Bilateral transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation, which may help in visual function recovery of adult patients with amblyopia. This pilot study will test the feasibility of said therapy, along with the short term effects of bilateral tDCS in visual function.
The goal of this study is to quantify the improvement in completed ophthalmology referrals and quantify the number of children identified and treated for amblyopia or pre amblyopic strabismus resulting from the implementation of a new referral and tracking system.
Follow-up of pediatric patients is important for their regular ocular morbidity monitoring, especially for amblyopia management. An observatory data of 1st week (1st to 7th) of January 2019 revealed that the follow-up compliance was very low (22%) among children aged 0-16 years in the pediatric department of Bharatpur Eye Hospital. A problem tree analysis showed a lack of awareness in children and their parents regarding the importance of follow-up and patients forgetting regarding the follow-up visit, usually when there is the long duration of follow up are the major contributing factors for poor adherence to follow-up. So, an intervention study was aimed at finding the effectiveness of counseling and reminders through SMS and phone calls to improve the follow-ups. All pediatric patients 0-16 years of age with ocular conditions requiring at least 3 follow-ups in the study period (January 2021 to April 2021) will be included. Two hundred and sixty-four participants will be equally distributed to three groups: routine standard care, counseling, and reminders with SMS and phone calls. In the routine care group, children will undergo routine care as per existing practice in the hospital and there will be no additional intervention. In counseling group, in addition to routine care parents/guardians along with the child will receive counseling from a trained counselor as per the set counseling protocol in every follow-up visits and will also be provided with the disease-specific information leaflets as additional information material before the child is discharged from the department. In the SMS and phone call reminder group, in addition to routine care, parents/guardians of children will receive reminders through short messaging text (SMS) 3 days and phone calls one day prior to the scheduled visit. Compliance to follow up Participants completing all the three follow-up visits as per the schedule within the window period of +/-2 days will be considered as a complaint to follow up. However, the follow-ups of all the participants will be recorded although that is beyond the window period. The primary outcome will be measured by the proportion of children completing all three scheduled follow-ups. The ethical approval has been obtained from the Institutional Review Committee of NHRC (ERB protocol registration number 761/2020 P). Informed consent will be taken from parent and child. Conclusion: If interventions improve the follow-up rate and are cost-effective, this can be applied in all the departments of the hospital.
The NEIVATECH system has been designed to provide binocular vision training to 7-15 year old amblyopic children by discriminating Gabor patches presented with different contrast to each eye as a perceptual learning task.
Screening A child is considered for the study after undergoing a standard of care and study specific eye examinations (by a study investigator as part of standard of care) that identifies amblyopia appearing to meet the eligibility criteria. The study will be discussed with the child's parent(s) or guardian(s) (referred to subsequently as parent(s)). Parent(s) who express an interest in the study will be given a copy of the informed consent form to read. Written informed consent / assent must be obtained from a parent and child prior to performing any study-specific procedures that are not part of the child's routine care. On screening visit, eligibility assessment, medical history,Demographic data, Refraction and Cycloplegia, Demonstration suitability using the CureSight, ATS Diplopia Questionnaire, Symptom Survey Distance VA Testing , Ocular Alignment Testing, Near VA Testing, Stereoacuity Testing-Randot, Stereoacuity Testing- Titmus Fly, Eye movement exams (optional), Contrast sensitivity (optional), Reading rest (optional) Randomization The EDC and data management will construct a Master Randomization List using a permutated block design stratified by initial visual acuity in the amblyopic eye and age which will specify the order of treatment group assignments. Randomization will be managed directly by the eCRF platform. All eligible subjects enrolled in the study will be followed for 16 weeks. Subjects will be randomly assigned in a 1:1 allocation to one of the following treatment groups for 16 weeks: 1. Binocular treatment 90 minutes per day, 5 days per week 2. Patching group: Patching 2 hours per day, 7 days per week. Follow up visits - 1-week phone call (4 to 8 days from randomization) to inquire about issues with the CureSight system (if applicable) and to encourage compliance with treatment for all groups (to be completed by site personnel) - Visit 2: 4 weeks ± 1 week - Visit 3: 8 weeks ± 1 week - Visit 4: 12 weeks ± 1 week - Visit 5: 16 weeks ± 1 week (primary endpoint) - Unmasking of primary outcome results - For each individual subject, clinician's decision regarding: Treatment or control cessation and follow-up; or, Control (patching) continuation with same modality (more improvement desired); or, Cross-over to a different treatment (avoid missing the optimal window of opportunity in young age) •Optional Visit 6: 28 weeks ± 1 week (exploratory outcome, including retainment of improvement; and additional exploratory outcomes
The purpose of this PoC study was to evaluate the potential therapeutic efficacy of binocular video games played on a tablet and to compare the efficacy of binocular video games versus patching in amblyopic patients 4 to 7 years old (Part A) as well as to gain experience with binocular video games in older children population of 8 to12 years old (Part B). Part A and Part B was designed to provide long term data on durability of binocular video games treatment. The study consisted of two parts, Part A: randomized, single masked PoC study in children 4 to 7 years old at Screening, and Part B: open-label substudy in children 8 to 12 year old at Screening.
In a randomized controlled trial, we will establish whether early glasses for high refractive error at age one reduce the development of amblyopia between age one and four. As a secondary outcome early literacy will be compared in groups with and without glasses.
This is an analysis of tests of near vision. Visual perception testing using a novel program on an interactive three dimensional electronic device: Autostereoscopic dynamic near games for monocular visual acuity, stereopsis and color are compared with other conventional or similar tests.