UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060228 |
|---|---|
| Receipt number | R000068887 |
| Scientific Title | The National Registry of Corneal Endothelial Damage after Glaucoma Surgery in Japan |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2025/12/29 08:47:35 |
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Basic information
Public title
The National Registry of Corneal Endothelial Damage after Glaucoma Surgery in Japan
Acronym
NR-CEGlaS
Scientific Title
The National Registry of Corneal Endothelial Damage after Glaucoma Surgery in Japan
Scientific Title:Acronym
NR-CEGlaS
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, the range of glaucoma surgical procedures has expanded, enabling stage-specific treatment selection. However, in some cases, irreversible complications such as corneal endothelial cell damage can occur after glaucoma surgery, which remains a major challenge in glaucoma management. This study aims to generate foundational data to support the development of future guidance on indications, postoperative care, and prevention of endothelial damage in glaucoma surgery by investigating the real-world burden and incidence of postoperative corneal endothelial cell damage and by establishing effective treatment strategies.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage change in central corneal endothelial cell density at 12 months postoperatively
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent glaucoma surgery combined with cataract extraction at the participating institutions during the study period, including drainage device implantation, trabeculotomy, trabeculectomy, PreserFlo MicroShunt implantation, Ex-PRESS shunt implantation, and other glaucoma device implantation procedures.
Key exclusion criteria
Patients lacking preoperative corneal endothelial cell evaluation, as well as those judged unsuitable for inclusion by the principal investigator or sub-investigators at each participating center.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Inatomi |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Ophthalmology
Zip code
474-8511
Address
7-430 Morioka-cho, Obu City, Aichi Prefecture, Japan
TEL
0562-46-2311
tinatomi@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Yo |
| Middle name | |
| Last name | Okada |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Ophthalmology
Zip code
474-8511
Address
7-430 Morioka-cho, Obu City, Aichi Prefecture, Japan
TEL
0562-46-2311
Homepage URL
y-okada@koto.kpu-m.ac.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Glaucoma Society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Ethics and Conflict of Interest Committee, National Center for Geriatrics and Gerontology
Address
7-430 Morioka-cho, Obu City, Aichi Prefecture, Japan
Tel
0562-46-2311
yaday@ncgg.go.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 | 02 | Month | 01 | 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 | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multicenter retrospective observational study with no interventional procedures.
Patients who underwent glaucoma surgery combined with cataract extraction at participating institutions between October 1, 2021, and September 30, 2024 are eligible. The glaucoma procedures include drainage device implantation, trabeculotomy, trabeculectomy, PreserFlo MicroShunt implantation, Ex-PRESS shunt implantation, and other glaucoma device implantation surgeries.
The primary factor (exposure) of interest is the surgical procedure category as defined above. The primary outcome is the percentage change in central corneal endothelial cell density at 12 months postoperatively. Sampling will include consecutive (or all eligible) cases at each site, and data will be collected from existing clinical records.
Management information
Registered date
| 2025 | Year | 12 | Month | 29 | Day |
Last modified on
| 2025 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068887
