UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057374 |
|---|---|
| Receipt number | R000065562 |
| Scientific Title | Effects of preoperative use of prostanoid FP receptor agonists on the outcome of trabeculectomy and Ahmed glaucoma valve implantation |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/24 12:30:12 |
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Basic information
Public title
Effects of preoperative use of prostanoid FP receptor agonists on the outcome of trabeculectomy and Ahmed glaucoma valve implantation
Acronym
Effects of preoperative use of prostanoid FP receptor agonists on the outcome of trabeculectomy and Ahmed glaucoma valve implantation
Scientific Title
Effects of preoperative use of prostanoid FP receptor agonists on the outcome of trabeculectomy and Ahmed glaucoma valve implantation
Scientific Title:Acronym
Effects of preoperative use of prostanoid FP receptor agonists on the outcome of trabeculectomy and Ahmed glaucoma valve implantation
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of preoperative use of prostanoid FP receptor agonists on the postoperative outcomes in glaucoma patients who underwent trabeculectomy or Ahmed glaucoma valve implantation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intraocular pressure
Key secondary outcomes
Cumulative survival rate
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 diagnosed with glaucoma who underwent trabeculectomy and/or Ahmed glaucoma valve implantation at Nagoya City University Hospital and were available for postoperative follow-up for at least one year.
Key exclusion criteria
Cases that were lost to follow-up at Nagoya City University within one year after surgery.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Yasukawa |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
+81-52-8538251
yasukawa@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masayo |
| Middle name | |
| Last name | Kimura |
Organization
Nagoya City University East Medical Center
Division name
Ophthalmology
Zip code
464-8547
Address
1-2-23 Wakamizu,Chikusa-ku,Nagoya,464-8547
TEL
052-721-7171
Homepage URL
kimuram030301@yahoo.co.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
institutional review board of Nagoya City University Graduate School of Medical Science
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
Tel
052-858-7215
clinical_research@med.nagoya-cu.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
| 2025 | Year | 04 | 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
241
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In trabeculectomy, the type of preoperative prostanoid FP receptor agonist used may influence postoperative outcomes. This study aims to investigate its effects on Ahmed glaucoma valve implantation.
Management information
Registered date
| 2025 | Year | 03 | Month | 24 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065562
