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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035995
Receipt No. 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 2019/02/25

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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 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Kaneko
Organization Nagoya University Hospital
Division name Ophthalmology
Zip code
Address 65, tsurumai-cho, shouwa-ku, Nagoya, Aichi
TEL 052-744-2277
Email h-kaneko@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sayuri Yasuda
Organization Nagoya University Hospital
Division name Ophthalmology
Zip code
Address 65, tsurumai-cho, shouwa-ku, Nagoya, Aichi
TEL 052-744-2277
Homepage URL
Email yamauchi.sayuri@a.mbox.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 06 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2019 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040985

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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