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Amblyopia clinical trials

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NCT ID: NCT06429280 Recruiting - Amblyopia Clinical Trials

Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

Start date: September 1, 2023
Phase:
Study type: Observational

Amblyopia is the most prevalent cause of reduced monocular visual acuity in children and young adults, with estimates of prevalence ranging from 1% to 5%. The most common associated amblyogenic risk factors are uncorrected anisometropia, strabismus, or a combination of these. In addition to reduced visual acuity, amblyopic patients may also have measurable dysfunction of accommodation, fixation, binocularity, vergence, reading fluency, depth perception, and contrast sensitivity. For the first time since the incorporation of atropine penalization into amblyopia management, physicians can now offer Luminopia, an FDA-approved dual action dichoptic treatment, to patients with amblyopia. Since the product became commercially available in November 2022, the number of patients on Luminopia therapy continues to grow. This presents a unique opportunity to gather real world evidence from a large number of patients, representative of how ophthalmologists and optometrists are applying this novel treatment in the real world. A registry of the clinical data associated with Luminopia treatment, with IRB oversight, will provide answers to key scientific questions using a large dataset.

NCT ID: NCT06372548 Recruiting - Amblyopia Clinical Trials

Rehabilitation Training Games for Children With Amblyopia

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

A gamification product was developed to guide children with amblyopia to develop rehabilitation training habits by combining cognitive evaluation theory and occlusion therapy. A randomized controlled trial was conducted to examine the ease of use, acceptability and treatment compliance of the game.

NCT ID: NCT06286410 Recruiting - Clinical trials for Accommodation Disorder

Accommodation Response in Hypermetropic Anisometropia (ARIHA Study)

ARIHA
Start date: April 11, 2024
Phase: N/A
Study type: Interventional

Anisometropic amblyopia is when one eye has a much stronger glasses prescription than the other, causing poor vision in one eye, even with glasses, because the brain favours the better-seeing eye. With standard care treatment (glasses plus either patching or atropine drops given to the better seeing eye), 35% of children with anisometropic amblyopia do not have any significant visual improvements, and will have reduced vision in one eye for life. There is no consensus for the reasons why some children do not respond as well as others. Recent research using the Plusoptix PowerRefractor (PR3), which quickly measures eye focusing (accommodation), suggested that in children with anisometropic amblyopia, the focusing of the amblyopic eye might influence treatment success. However, such measurements weren't previously common due to equipment limitations in clinics. The investigators aim to use the non-invasive PR3 to assess accommodation in hypermetropic anisometropic amblyopia, at the University of Sheffield. This will be a two-phase study of children aged 4-10 years who have hypermetropic anisometropia. The investigators will recruit participants attending the Ophthalmology Department at Sheffield Children's NHS Foundation Trust (SCH). The investigators will take repeated measurements of accommodation at points during standard care treatment (phase 1) and conduct a pilot intervention study (phase 2) to determine whether adjusting glasses prescriptions based on accommodation responses with amblyopia treatment can improve vision in the weaker eye. The goal is to gather evidence to inform a future larger multicentre RCT to improve the visual outcomes for anisometropic amblyopic children in the future.

NCT ID: NCT06224751 Recruiting - Clinical trials for Macular Degeneration

Developing Better Computerised Vision Tests (CVTV)

CVTV
Start date: April 2024
Phase:
Study type: Observational

Clinical vision measurements usually involve printed charts with an eye care professional interpreting patient responses to generate a score. Those scores determine the need for or outcome of treatment. Detecting change can be improved with strict procedures/scoring, lending itself to computerisation. This in turn allows integration with electronic medical records. Many eye tests could be computerised in this way. At Guys and St Thomas' NHS Foundation Trust, the investigators have developed and validated a computerised test of distance visual acuity, called COMPlog which is now in widespread use. The investigators now want to increase the range of tests available. There is also a need to longitudinally monitor for adverse change. Such monitoring must be developed to keep false positive and false negative change detection to a minimum. The aims of this two year linked program are to: Part A) validate an extended range of computerised vision measurement tests against their gold standard hard copy printed equivalents. Some of these tests are designed for use in children and all are meant to quantify both normal and impaired vision. Patients of all ages and visual function will therefore be recruited from St Thomas' Hospital. The specific tests we aim to validate are logMAR Letter Near Acuity, Word Near Acuity, Letter Contrast Sensitivity, Auckland Optotypes Picture Acuity, Low Contrast Letter Acuity, Stereoacuity and Vanishing Optotypes. Patients will undergo test-retest measurements with up to two of these. Part B) Iteratively develop an application for use in home monitoring of subjects at risk of treatable vision loss due to age related macular degeneration. All computerised tests in parts A and B will be performed on prototype software. Eye patients will be recruited as subjects. Patients recruited to part A will undergo tests on one day for up to an hour, subjects in part B will participate for between 1 hour and two months.

NCT ID: NCT06165705 Recruiting - Amblyopia Clinical Trials

Treating Amblyopia With SureSight

ABCDCS
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

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

NCT ID: NCT06150391 Recruiting - Amblyopia Clinical Trials

Evaluation of Amblyopia Protocols Using a Dichoptic Gabor Videogame Program

Start date: October 5, 2023
Phase: N/A
Study type: Interventional

Interest in developing alternative methods for the treatment of amblyopia (lazy eye) has long been a topic of interest among clinicians and researchers. Occlusion or penalization of fellow eye do not always provide the desired visual acuity improvement. Moreover, occlusion is associated with a high risk of recurrence and non-compliance. Here, it is presented a protocol of a randomized clinical trial to evaluate the safety and clinical efficacy of a novel home-based system, based on a computer game. The goal of this prospective clinical trial is to compare in visual acuity improvements in patients with amblyopia, following conventional patching therapy or this novel computer-based therapy. The main questions it aims to answer are: - Does computer-based therapy equal or improve patching therapy? Can it be used as an alternative to patching? - Does computer-based therapy used in combination with pathching solve amblyopia when patching fails alone (persistent amblyopia)? Participants will be divided in two groups according to the previous occlusion o penalization of fellow eye. Both groups will be divided in two subgroups, experimental and control. Researchers will compare subgroups outcomes in order to asses this novel approach.

NCT ID: NCT06049459 Recruiting - Amblyopia Clinical Trials

Novel Amblyopia Treatment With Virtual Reality Games

Start date: March 14, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to compare the change in amblyopic eye acuity between treatment periods in children with amblyopia, aged 5-17 years. The main question it aims to answer is: Is a 16-week course of amblyopia treatment using Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for approx. 25 min/day, 6 days/week more effective for improvement in amblyopic-eye VA, binocularity (stereoacuity, suppression, alignment), contrast sensitivity, attention, oculomotor function, visual-motor integration, and quality of life than 16 weeks of continued glasses alone? Participants will each serve as their own control and complete: Treatment period 1: Continued optical correction (glasses) alone for 16 weeks; Treatment period 2: Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for 16 weeks (approx. 25min/day, 6 days/week) plus continued optical correction

NCT ID: NCT05811598 Recruiting - Myopia Clinical Trials

Real Word Study on Myopia Control With Repeated Red Light Therapy for Ages of 3~6 Years Old

RMC
Start date: March 21, 2023
Phase: N/A
Study type: Interventional

Repeated Red Light Therapy had been used as an amblyopia therapy for children as well as the myopia control in primary schools. However, ultra low lever of red light therapy with irradiance of 0.37mW and 0.60mW effectiveness and safety for 3~ 6 year-old myopia treatment or slow myopia progression are seldom reported.

NCT ID: NCT05732467 Recruiting - Amblyopia Clinical Trials

Effectiveness of Virtual Reality Training in Amblyopia

Start date: November 14, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy and safety of visual function training software (model: SJ-JRS2021) in the treatment of mild to moderate amblyopia in children. The main questions it aims to answer are: - Whether virtual reality training is more effective than occlusion therapy - Safety of virtual reality training in amblyopia treatment If participants have refractive problems, correct the refraction first and wear corrective glasses. The experimental group will be treated using visual function training therapy software (model: SJ-JRS2021). The control group will be treated with occlusion therapy covering the contralateral eye for 2 hours a day. Researchers will compare experimental group with control group to see if the experimental group has better corrected vision recovery.

NCT ID: NCT05714449 Recruiting - Amblyopia Clinical Trials

OCT Eccentric Fixation and Amblyopia in Children

Start date: January 25, 2023
Phase: N/A
Study type: Interventional

The objectives of this proposal are to characterize the relationship between OCT eccentric fixation (OCT-EF), fixation eye movement (FEM), macular sensitivity in children with amblyopia.