UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031482 |
|---|---|
| Receipt number | R000035935 |
| Scientific Title | Study of the effect of topical trehalose on postoperative clinical course after trabeculectomy |
| Date of disclosure of the study information | 2018/02/26 |
| Last modified on | 2023/03/06 10:14:39 |
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Basic information
Public title
Study of the effect of topical trehalose on postoperative clinical course after trabeculectomy
Acronym
Effect of topical trehalose on the filtering bleb after trabeculectomy
Scientific Title
Study of the effect of topical trehalose on postoperative clinical course after trabeculectomy
Scientific Title:Acronym
Effect of topical trehalose on the filtering bleb after trabeculectomy
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of topical trehalose on the maintenance of filtering bleb and control of intraocular pressure after trabeculectomy for glaucoma patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
postoperative volume of the filtering bleb for 6 months after surgery
Key secondary outcomes
level of intraocular pressure control for 6 months after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
instillation of 5% trehalose 4times a day for one month after surgery in addition to the other regular postoperative medications
Interventions/Control_2
instillation of sterile saline 4times a day for one month after surgery in addition to the other regular postoperative medications
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
trabeculectomy naive eye
Key exclusion criteria
eyes which were previously treated by trabeculectomy
fellow eye of the participant
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Nakazawa |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki, 036-8562, Japan
TEL
0172-39-5094
mitsuru@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Nakazawa |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki, 036-8562, Japan
TEL
0172-39-5094
Homepage URL
https://kakenhi.nil.ac.jp/ja/file/KAKENHI-PROJECT-17K11416seika.pdf
mitsuru@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Department of Ophthalmology
Institute
Department
Personal name
Nakazawa, Mitsuru
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki University Committee for Clinical Research
Address
43 Honcho, Hirosaki, 036-8562, Japan
Tel
0172-39-5362
crb-hirosaki@hirosaki-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
弘前大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
https://kaken.nil.ac.jp/ja/file/KAKENHI-PROJECT-17K11416seika.pdf
Publication of results
Published
Result
URL related to results and publications
https://kaken.nil.ac.jp/ja/file/KAKENHI-PROJECT-17K11416seika.pdf
Number of participants that the trial has enrolled
12
Results
The results obtained were that the total area of cystic spaces in the bleb was 31,075.3 (SD, 31,748.9) pixels in the treatment group, and 39,337.2 (SD, 56,161.0) pixels in the control group. There was no statistically significant difference (P = 1.00, Mann-Whitney test).
Results date posted
| 2022 | Year | 03 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 05 | Month | 22 | Day |
Baseline Characteristics
patients with glaucoma who undergo trabeculectomy as the first surgery
Participant flow
topically instilled 5% trehalose solution or sterile saline 4 times a day for 30 days postoperatively
Adverse events
none
Outcome measures
intraocular pressure and morphology of filtering bleb
Plan to share IPD
none
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 26 | Day |
Last modified on
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035935
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/03/06 | 【2018-A-002】⑤研究計画書_第4版.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/03/08 | 研究症例データ仕様書.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/03/08 | 研究症例データ仕様書.docx |
