UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027136 |
|---|---|
| Receipt number | R000031093 |
| Scientific Title | Measurement of cyclodeviation using SD-OCT |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2020/04/28 10:37:49 |
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Basic information
Public title
Measurement of cyclodeviation using SD-OCT
Acronym
Measurement of cyclodeviation using SD-OCT
Scientific Title
Measurement of cyclodeviation using SD-OCT
Scientific Title:Acronym
Measurement of cyclodeviation using SD-OCT
Region
| Japan |
Condition
Condition
Normal volunteers
Cyclotropia
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of OCT for measurement of
objective cyclodeviation in normal volunteer, patients with cataract and cyclotropia.
Basic objectives2
Others
Basic objectives -Others
Changes of objective cyclodeviation before and after ophthalmologic procedures
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
objective cyclodeviation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Objective cyclodeviation is measured by OCT in
normal volunteers and patients with cataract and cyclotropia before and after procedures.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Normal volunteers
Patients with Cataract: best corrected visual acuity >0.6
Patients with cyclotropia: best corrected visual acuity >0.6
Key exclusion criteria
Patients received any ophthalmological surgeries within 6 months before this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Fumi |
| Middle name | |
| Last name | Gomi |
Organization
Hyogo College of Medicine
Division name
Ophthalmology
Zip code
6638501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan 663-8501
TEL
0798-45-6462
fgomi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Ishikawa |
Organization
Hyogo College of Medicine
Division name
Ophthalmology
Zip code
6638501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan 663-8501
TEL
0798-45-6462
Homepage URL
ohmyeye@hyo-med.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Hyogo College of Medicine
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan 663-8501
Tel
+81-798456066
rinri@hyo-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
兵庫医科大学病院 眼科
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://tvst.arvojournals.org/article.aspx?articleid=2762037
Number of participants that the trial has enrolled
40
Results
In all cases, symptoms related to cyclodeviation
resolved postoperatively. All measurements were positively correlated before
surgery. Postoperatively, changes in all measurements were also correlated. However, all
synoptophore-related data were underestimated when compared with OCT and fundus
photography.
Results date posted
| 2020 | Year | 04 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 02 | Month | 25 | Day |
Baseline Characteristics
Forty patients with cyclodeviation who had undergone strabismus surgery were enrolled. Patients were predominantly male(N=25) with a mean age of 58.6 years(range 15-85). All patients complained of diplopia preoperatively and showed excyclotropia, symptoms were due to acquired fourth cranial palsy (N=14), congenital superior oblique muscle palsy (N=13), thyroid-associated ophthalmopathy (N=6), sequelae of cerebral infarction (N=2), third cranial nerve palsy (N=1), double elevator palsy (N=1), ocular tilt reaction (N=1), sagging eye syndrome (N=1), and myasthenia gravis (N=1). In all cases, symptoms related to cyclodeviation resolved postoperatively.
Participant flow
We extracted data from medical records including age, gender, and ocular torsion angle. Measurements of ocular torsion angle, using a synoptophore for subjective and fundus photography and OCT for objective measurements, were taken before surgery and one day after surgery.
Adverse events
None.
Outcome measures
The primary endpoint was similarity of OCT compared with fundus photography when comparing ocular torsion angle. Comparison of OCT with synoptophore and comparison of changes in ocular torsion angle between pre- and post-operative measurements were secondary endpoints. We also assessed the baseline characteristics of all patients.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 26 | Day |
Last modified on
| 2020 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031093
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