UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044584 |
|---|---|
| Receipt number | R000050923 |
| Scientific Title | Study on Ocular changes after strabismus srugery |
| Date of disclosure of the study information | 2021/06/18 |
| Last modified on | 2024/09/09 14:56:35 |
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Basic information
Public title
Study on eye changes after eye muscle surgery
Acronym
Eye and strabismus surgery
Scientific Title
Study on Ocular changes after strabismus srugery
Scientific Title:Acronym
Ocular change and strabismus surgery
Region
| Japan |
Condition
Condition
strabismus
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate structual and functional change after strabismus surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of intraocular pressure
Key secondary outcomes
Change of eye position
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
muscle transposition
Interventions/Control_2
recess resect procedure
Interventions/Control_3
muscle transpoisition and medial rectus recession
Interventions/Control_4
no treatment
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
available of multiple IOP measurements
Key exclusion criteria
unable of multiple IOP measurements
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Miho |
| Middle name | |
| Last name | Sato |
Organization
Hamamatsu university school of medicine
Division name
ophthalmology
Zip code
431-3192
Address
Handa-yama, Higashi-Ku, Hamamatsu
TEL
0534352256
mihosato@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Sato |
Organization
Hamamatsu university school of medicine
Division name
ophthalmology
Zip code
431-3192
Address
Handa-yama, Higashi-Ku, Hamamatsu
TEL
0534352256
Homepage URL
mihosato@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Kakenhi
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
Hamamatsu university school of medicine
Address
Handa-yama, Higashi-Ku, Hamamatsu
Tel
0534352256
mihosato@hama-med.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
浜松医科大学（静岡県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
Results
Using anterior segment OCT, we compared the conjunctiva thickness between resection and plication. The difference disappeared 3 months after surgery.
We compared the changes in intraocular pressure before and after strabismus surgery on patients with highly myopic strabismus. The intraocular pressure during abduction increased significantly in patients with contracture of the medial rectus muscle, and the difference disappeared after surgery.
Results date posted
| 2024 | Year | 09 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 01 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 17 | Day |
Last modified on
| 2024 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050923
