Tokyo, Oct. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063069) titled 'Effects of Lighting Conditions on Physiological Responses in Patients with Glaucoma' on Oct. 9.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Tohoku University

Condition: Condition - glaucoma and participants without glaucoma as controls Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to compare the effects of LED illumination and natural-light illumination on physiological responses in patients with broadly defined open-angle glaucoma and control participants. Changes associated with light exposure under each lighting condition will be assessed based on tear-film and pupillary examinations, ocular blood flow measurements, optical coherence tomography, assessment of autonomic nervous system function, tear oxidative stress markers, salivary stress markers, contrast sensitivity, reading performance, and questionnaires assessing subjective symptoms. By comprehensively analyzing physiological responses to different lighting environments, this study aims to obtain foundational evidence that may help identify suitable lighting environments for patients with glaucoma. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Lighting sequence A: Participants will be exposed to conventional LED illumination for 2 hours at the first study visit and to natural-light illumination for 2 hours at the second study visit. Interventions/Control_2 - Lighting sequence B: Participants will be exposed to natural-light illumination for 2 hours at the first study visit and to conventional LED illumination for 2 hours at the second study visit.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Glaucoma group:

1. Participants aged 18 to 75 years 2. Patients with broadly defined open-angle glaucoma attending the ophthalmology clinic of Tohoku University Hospital or Seiryo Eye Clinic 3. Participants who are able to undergo examinations on two study days at the study site 4. Participants who provide written informed consent to participate in the study

Control group:

1. Participants aged 18 to 75 years 2. Participants without glaucoma 3. Participants who are able to undergo examinations on two study days at the study site 4. Participants who provide written informed consent to participate in the study Key exclusion criteria - 1. Participants who are unable to provide written informed consent 2. Participants from whom saliva or tear samples cannot be collected 3. Participants with severe cataract, macular disease, or corneal disease that makes visual function assessment difficult 4. Participants with a multifocal intraocular lens 5. Participants who are unable to perform the reading task 6. Participants who are unable to refrain from using electronic devices during light exposure 7. Participants who are unable to undergo light exposure without habitual spectacles or contact lenses, either uncorrected or corrected with trial lenses Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 14 Day Date of IRB - 2026 Year 09 Month 17 Day Anticipated trial start date - 2026 Year 10 Month 12 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072103

Disclaimer: Curated by HT Syndication.