Clinical Trial: A Study on the Efficacy of Retinal Projection Visual Aids (Japan)

Tokyo, May 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061322) titled 'A Study on the Efficacy of Retinal Projection Visual Aids' on May 20.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Tohoku University

Condition: Condition - Low vision among patients currently receiving outpatient care at Tohoku University Hospital Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to evaluate the effectiveness of a retinal-projection visual aid device among individuals with low vision. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Retinal-projection visual aid

Eligibility: Age-lower limit - 12 years-old = Gender - Male and Female Key inclusion criteria - (1) Blindness, according to the WHO (World Health Organization) definition as corrected visual acuity of less than 0.05 in the better eye or a corresponding visual field defect (i.e., a visual field of 10 degrees or less), or low vision, defined as corrected visual acuity of 0.05 or higher but less than 0.3 in the better eye. This includes individuals with visual impairments equivalent to these criteria who experience difficulties in daily life, individuals with visual impairments equivalent to those covered by a visual impairment certificate, and individuals who qualify for receiving low vision care that uses their remaining visual function (excluding care related to the use of Braille). (2) Age 12 to 70 years (at the time of registration). (3) Consent to participate in the study from either the participant or their family. Key exclusion criteria - (1) Difficulty operating the retinal projection visual aid device; (2) lack of ability to understand the content of examinations or questionnaires; (3) no remaining function in the retina or optic nerve; (4) current use of medications or other treatments designed to enhance retinal sensitivity; (5) history of photosensitivity. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 01 Day Anticipated trial start date - 2026 Year 05 Month 20 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070053

Disclaimer: Curated by HT Syndication.