UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035995 |
|---|---|
| Receipt number | R000040985 |
| Scientific Title | Effect of strabismus surgery on retina and choroidal thickness and retinal vascular layer |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2023/03/01 14:28:10 |
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Basic information
Public title
Effect of strabismus surgery on retina and choroidal thickness and retinal vascular layer
Acronym
Effect of strabismus surgery on retina and choroidal thickness and retinal vascular layer
Scientific Title
Effect of strabismus surgery on retina and choroidal thickness and retinal vascular layer
Scientific Title:Acronym
Effect of strabismus surgery on retina and choroidal thickness and retinal vascular layer
Region
| Japan |
Condition
Condition
strabismus
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Strabismus surgery is done by cutting off the extraocular muscle from the sclera or resecting a part of the muscle and suturing the muscle stump to another position. In the operation of esotropia or exotropia, one or two extraocular muscles of one eye or both eyes are often treated based on the angle of deviation before surgery, and many studies have been done on the surgical method. It has been said that excessive resection of extraocular muscles induces intraocular circulatory failure before, but there are no clear standards for it, and reports analyzing numerically the circulatory failure is extremely rare. The purpose of this study is to measure intraocular circulation failure which has been vaguely recognized so far by using the latest ophthalmic equipment and measure the influence on the retina and choroid as a numerical value.
Basic objectives2
Others
Basic objectives -Others
We measure the thickness and vascular layer of the retina and choroid before and after strabismus surgery using ophthalmological tests such as optical coherence tomography, optical coherence tomography angiography, and laser speckle flowgraphy to consider the effect on the retina and choroid.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Choroidal thickness measured by optical coherence tomography before and 1 week, 1 month, 3 months after strabismus surgery.
Key secondary outcomes
Retinal thickness measured by optical coherence tomography, foveal avascular zone, vessel density, vessel length, and vascular diameter index measured by optical coherence tomography angiography, and ocular blood flow of the optic nerve head, retinal vessels, and choroid measured by laser speckle flowgraphy before and 1 week, 1 month, 3 months after strabismus surgery.
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
| 3 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients of undergoing a strabismus surgery.
In the control group, when the strabismus surgery is not performed on the opposite eye, the opposite eye is adopted, and in the case of performing a strabismus surgery on the opposite eye, patients who don't have history of ophthalmic surgery and history of retina and choroidal disease are selected.
Key exclusion criteria
A case in which ophthalmic examination can not be performed because he moves.
A case in which corneal opacity exists and images can not be examined before and after surgery.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kaneko |
Organization
Nagoya University Hospital
Division name
Ophthalmology
Zip code
466-8560
Address
65, tsurumai-cho, shouwa-ku, Nagoya, Aichi
TEL
052-744-2277
h-kaneko@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Sayuri |
| Middle name | |
| Last name | Yasuda |
Organization
Nagoya University Hospital
Division name
Ophthalmology
Zip code
466-8560
Address
65, tsurumai-cho, shouwa-ku, Nagoya, Aichi
TEL
052-744-2277
Homepage URL
yasuda.sayuri.i2@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Nagoya University Medical School Hospital Life Ethics Review Committee
Address
65, tsurumai-cho, shouwa-ku, Nagoya, Aichi
Tel
052-744-2423
ethics@med.nagoya-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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
We will do a prospective study.
We will select patients undergoing strabismus surgery between March 1, 2019 - March 31, 2022 at the Nagoya University Hospital. In cases without strabismus surgery on the opposite eye, the opposite eye is used as a control. For cases where strabismus surgery is performed on both eyes, target group is set from patients who do not have history of retina and choroidal disease and history of an ophthalmologic surgery.
Statistical analysis is performed using the obtained measurement result and age, sex, and the like.
As a statistical method, we compare two groups using (parametric) t test or (non parametric) Mann Whitney U test.
Management information
Registered date
| 2019 | Year | 02 | Month | 25 | Day |
Last modified on
| 2023 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040985
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