UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061684 |
|---|---|
| Receipt number | R000070431 |
| Scientific Title | Association Between Glycemic Variability and the Risk of Glaucoma Progression in Patients with Diabetes |
| Date of disclosure of the study information | 2026/05/30 |
| Last modified on | 2026/05/25 11:00:57 |
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Basic information
Public title
Association Between Glycemic Variability and the Risk of Glaucoma Progression in Patients with Diabetes
Acronym
Glycemic Control and the Risk of Glaucoma Progression in Patients with Diabetes
Scientific Title
Association Between Glycemic Variability and the Risk of Glaucoma Progression in Patients with Diabetes
Scientific Title:Acronym
Glycemic Control and the Risk of Glaucoma Progression in Patients with Diabetes
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether hypoglycemic episodes are associated with subsequent glaucoma progression in patients with diabetes and glaucoma.
Basic objectives2
Others
Basic objectives -Others
We will also explore whether this association is modified by the frequency and severity of hypoglycemia, as well as by medications and comorbidities.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Performance of glaucoma surgery, defined by the medical procedure code corresponding to glaucoma-related surgery (K268)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older with diabetes who have been prescribed insulin or sulfonylureas and have a diagnosis of glaucoma.
Key exclusion criteria
1) Patients with glaucoma diagnoses other than those specified above Applicable diagnostic codes: H40.0, H40.2, H40.3, H40.4, H40.5, H40.6, H40.8, H40.9, H42
2) Patients with comorbid diseases that may cause severe visual impairment and influence the decision to perform surgery, or diseases that may increase the frequency of medical visits and thereby contribute to surveillance bias, including age-related macular degeneration, proliferative diabetic retinopathy, diabetic macular edema, cystoid macular edema, retinal vascular occlusion, retinal detachment, macular hole, optic neuritis, and uveitis
Applicable diagnostic codes: H35.3, H34.8, H33, H35.81, H43.1, H35.34, H20, H30, H17, H46, H47
3) Patients who have previously undergone retinal photocoagulation, intravitreal injection, or vitrectomy
Procedure codes: K277, K280, K282
4) Patients with a total available data period of less than 6 years, including both the landmark period and the window period
5) Patients with missing information required to ascertain the primary outcome
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Ayana |
| Middle name | |
| Last name | Suzumura |
Organization
Nagoya University Hospital
Division name
Ophthalmology
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL
0527442275
suzumura.ayana.t5@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayana |
| Middle name | |
| Last name | Suzumura |
Organization
Nagoya University Hospital
Division name
Ophthalmology
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL
0527442275
Homepage URL
suzumura.ayana.t5@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Ayana Suzumura
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
Tel
0527442275
suzumura.ayana.t5@f.mail.nagoya-u.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 | 05 | Month | 30 | 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 | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data were extracted from a database provided by JMDC Inc., and landmark and multivariable analyses will be performed
Management information
Registered date
| 2026 | Year | 05 | Month | 25 | Day |
Last modified on
| 2026 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070431
