UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063069 |
|---|---|
| Receipt number | R000072103 |
| Scientific Title | Effects of Lighting Conditions on Physiological Responses in Patients with Glaucoma |
| Date of disclosure of the study information | 2026/10/09 |
| Last modified on | 2026/09/28 11:28:56 |
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Basic information
Public title
Effects of Lighting Conditions on Physiological Responses in Patients with Glaucoma
Acronym
Effects of Lighting Conditions on Physiological Responses in Patients with Glaucoma
Scientific Title
Effects of Lighting Conditions on Physiological Responses in Patients with Glaucoma
Scientific Title:Acronym
Effects of Lighting Conditions on Physiological Responses in Patients with Glaucoma
Region
| Japan |
Condition
Condition
glaucoma and participants without glaucoma as controls
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
To compare the effects of LED illumination and natural-light illumination on physiological responses, including autonomic nervous system function.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of autonomic nervous system function
Key secondary outcomes
Tear-film and pupillary parameters
Ocular blood flow parameters
Tear oxidative stress markers
Salivary stress markers
Retinal and choroidal thickness
Contrast sensitivity
Reading performance
Subjective visual symptoms
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 75 | 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 sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Tsuda |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-chou, Aoba-ku, Sendai,Miyagi
TEL
0227177294
satoru.tsuda.e3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yasuaki |
| Middle name | |
| Last name | Kamata |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-chou, Aoba-ku, Sendai,Miyagi
TEL
0227177294
Homepage URL
yasuaki.kamata.e1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Seoul Semiconductor Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine Ethics Committee
Address
1-1 Seiryo-chou, Aoba-ku, Sendai,Miyagi
Tel
0227173867
ec-med@grp.tohoku.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 28 | Day |
Last modified on
| 2026 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072103
