UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032749 |
|---|---|
| Receipt number | R000037155 |
| Scientific Title | Prospective observational study to improve the prognosis of glaucoma filtering surgery |
| Date of disclosure of the study information | 2018/05/28 |
| Last modified on | 2019/12/04 08:49:05 |
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Basic information
Public title
Prospective observational study to improve the prognosis of glaucoma filtering surgery
Acronym
Observational study for the filterig blebs
Scientific Title
Prospective observational study to improve the prognosis of glaucoma filtering surgery
Scientific Title:Acronym
Observational study for the filterig blebs
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prognosis after glaucoma filtering surgery prospectively
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of Birefringence of filtering blebs beteween success and failure after glaucoma filtering surgery
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
(1) Surgical patients who will undergo glaucoma filtering surgery
(2) Patients who understood and signed letter of consent
(3) Patients without ocular surface surgery affecting the flitering blebs,
Key exclusion criteria
(1) Patients who aren't able to visit the medical institution at pre-defined visits as instructed by the physician
(2) Patients assessed as inappropriate to be enrolled in this observational study by the physician
Target sample size
100
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-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL
81-22-717-7294
tsuda@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Kokubun |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL
81-22-717-7294
Homepage URL
t-kokubun@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
MHLW CertifieClinical Research Review Board, Tohoku University
Address
2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577 Japan
Tel
022-718-0461
office@nrs.hosp.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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a study to examine the differences between success and failure after glaucoma filtering surgery and to investigate the the factors to predict the prognosis after the surgery. We follow up the patients undergoing filtering surgery prospectively for 12 months after the surgery.
Management information
Registered date
| 2018 | Year | 05 | Month | 28 | Day |
Last modified on
| 2019 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037155
