UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000026820
Receipt No. R000030731
Scientific Title Measurement of ocular blood flow using by laser speckle flowgraphy as an intraoperative monitoring during carotid endarterectomy
Date of disclosure of the study information 2017/04/01
Last modified on 2020/10/09 (Ver. 5)

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Basic information
Public title Measurement of ocular blood flow using by laser speckle flowgraphy as an intraoperative monitoring during carotid endarterectomy
Acronym Ocular LSFG during CEA
Scientific Title Measurement of ocular blood flow using by laser speckle flowgraphy as an intraoperative monitoring during carotid endarterectomy
Scientific Title:Acronym Ocular LSFG during CEA
Region
Japan

Condition
Condition carotid artery stenosis
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare ocular blood flow by LSFG with preoperative balloon occlusion test for carotid endarterectomy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Agreement rate of intraoperative ocular blood flow by LSFG with finding on preoperative BOT
Key secondary outcomes Agreement rate of intraoperative ocular blood flow by LSFG with intraoperative monitoring including EEG, MEP, SEP, NIRS

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 medicine)mydriatic
maneuver)measurement of ocular blood flow
timing)during operation
frequency)3 times, before, during, after occlusion of ICA
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 Adult patients undergoing carotid endarterectomy.
Key exclusion criteria (1)patients with allegy for iodine agent
(2)patients with glaucoma
(3)patients who reject the study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yasushi
Middle name
Last name Motoyama
Organization Nara Medical University
Division name Department of Neurosrugery
Zip code 6348522
Address 840 Shijo-cho Kashihara city, Nara, Japan
TEL 0744298866
Email myasushi@naramed-u.ac.jp

Public contact
Name of contact person
1st name Yasushi
Middle name
Last name Motoyama
Organization Nara Medical University
Division name Department of Neurosrugery
Zip code 6348522
Address 840 Shijo-cho Kashihara city, Nara, Japan
TEL 0744298866
Homepage URL
Email myasushi@naramed-u.ac.jp

Sponsor
Institute Department of Neurosurgery, Nara Medical University
Institute
Department

Funding Source
Organization Department of Neurosurgery, Nara Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nara Medical University
Address 840 Shijo-cho
Tel +81744298866
Email myasushi@naramed-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 奈良県立医科大学付属病院

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 01 Day

Related information
URL releasing protocol https://naraidai-neuro.jp/kenkyu/
Publication of results Unpublished

Result
URL related to results and publications https://link.springer.com/article/10.1007%2Fs10877-020-00475-1
Number of participants that the trial has enrolled 19
Results 
The MBR reduction ratio between before and after carotid clamping ranged from -12 to 100%. The MBR reduction ratio was positively correlated with the rSO2 index (r=0.694, 95%CI: 0.336-0.877, p=0.001).
Results date posted
2020 Year 10 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Nineteen patients undergoing CEA with ocular blood flow measurement by LSFG and intraoperative monitoring (IOM) were prospectively enrolled between August 2016 and March 2019. The mean blur rate (MBR) of ocular blood flow by LSFG, representing relative blood flow of the branch of the retinal artery originating from the optic nerve head, was compared between before and after carotid clamping during CEA.
Participant flow 
During CEA, ocular blood flow was measured by LSFG 5 times. First, before the start of the operation, measurement of ocular blood flow by LSFG was performed as a control when the patient was placed on the operating table and the head was fixed by the skull clamp. After exposure of the carotid artery, ocular blood flow was measured by LSFG before carotid clamping as a baseline. Then, after carotid clamping, ocular blood flow was measured by LSFG to calculate the reduction ratio. After release of carotid clamping, followed by completed plaque removal and angiorrhaphy, ocular blood flow was measured by LSFG to confirm that blood flow of the carotid artery had restarted. Finally, ocular blood flow measured by LSFG was recorded at the end of surgery.

When an internal shunt was placed, measurement of ocular blood flow by LSFG was performed 7 times, by adding after insertion and then after removal of the internal shunt. The success rate of measurement of ocular blood flow by LSFG was calculated based on the number of successes divided by the total number of sessions.
Adverse events 
none
Outcome measures 
The MBR reduction ratio of ocular blood flow by LSFG after carotid clamping was significantly correlated with the rSO2 index. The ocular blood flow by LSFG could be considered an adjunct modality for evaluating cerebral ischemic tolerance during CEA.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 03 Month 30 Day
Date of IRB
2017 Year 03 Month 30 Day
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2019 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 01 Day
Last modified on
2020 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030731