Tokyo, Oct. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063294) titled 'A study of the effects of short-term training using a handheld eye movement training device on the ability to follow moving objects with the eyes' on Oct. 15.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Kitasato University
Condition:
Condition - No specific disease(healthy adults)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to investigate the effects of short-term repeated training using a newly developed handheld eye movement training device on horizontal and vertical smooth pursuit eye movements in healthy adults. The study will also evaluate the test-retest reliability and measurement error of eye movement measurements obtained using an eye movement tracking device, as well as the safety and feasibility of the training.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Short-term eye movement training will be performed using a newly developed handheld eye movement training device. Participants will follow a moving target presented 40 cm in front of their eyes while seated, with both eyes open and with minimal head movement. The target will be moved horizontally and vertically at a speed of 50 degrees per second.Each training block will consist of three sets of 16 seconds of horizontal tracking (eight cycles), a 15-second rest, 16 seconds of vertical tracking (eight cycles), and another 15-second rest, lasting approximately 3 minutes and 6 seconds per block. Participants will complete three training blocks at the second visit and three additional blocks at the third visit, 3 days later, for a total of six blocks. A 5-minute rest will be provided between blocks.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Healthy adults aged 18 to 30 years who are students at Kitasato University
2. Individuals with visual acuity of 1.0 or better, either uncorrected or corrected with contact lenses
3. Individuals who provide written informed consent after receiving an explanation of the study
Key exclusion criteria - 1.Individuals with ocular diseases that may affect eye movements
2.Individuals with manifest strabismus
3.Individuals with a history of amblyopia, except those diagnosed as having resolved amblyopia
4.Individuals who have undergone ophthalmic surgery within one year before study participation
Target Size - 35
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 24 Day
Date of IRB - 2026 Year 09 Month 24 Day
Anticipated trial start date - 2026 Year 10 Month 19 Day
Last follow-up date - 2027 Year 04 Month 06 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072448
Disclaimer: Curated by HT Syndication.