UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019636 |
|---|---|
| Receipt number | R000022695 |
| Scientific Title | Relationship between eyelid pressure and dry eye in patients with thyroid eye disease, ptosis, or facial nerve palsy. |
| Date of disclosure of the study information | 2015/11/10 |
| Last modified on | 2023/11/10 10:03:14 |
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Basic information
Public title
Relationship between eyelid pressure and dry eye in patients with thyroid eye disease, ptosis, or facial nerve palsy.
Acronym
Relationship between eyelid pressure and dry eye
Scientific Title
Relationship between eyelid pressure and dry eye in patients with thyroid eye disease, ptosis, or facial nerve palsy.
Scientific Title:Acronym
Relationship between eyelid pressure and dry eye
Region
| Japan |
Condition
Condition
Thyroid eye disease, ptosis, and facial nerve palsy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between eyelid pressure and dry eye in patients with thyroid eye disease, ptosis, or facial nerve palsy.
Basic objectives2
Others
Basic objectives -Others
Thyroid eye disease and ptosis: To examine changes in eyelid pressure and the severity of dry eye after orbital decompression or levator advancement.
Facial nerve palsy: To examine the difference in eyelid pressure and the severity of dry eye between the affected and unaffected sides.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Eyelid pressure and the severity of dry eye (slitlamp examination, meibography, Schirmer test, OCT, and DEQS).
Thyroid eye disease and ptosis: Before and 3 months after the operation.
Facial nerve palsy: At the outpatient examination.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Thyroid eye disease: 30 patients. Each patient will undergo the examinations after consent to this study and postoperative 3 months follow-up.
Facial nerve palsy: 10 patients. Each patient will undergo the examinations after consent to this study.
Examinations: eyelid pressure and the severity of dry eye (slitlamp examination, meibography, Schirmer test, OCT, and DEQS).
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
Patients aged 20 years or more.
Patients with consent to this study.
Key exclusion criteria
Patients without consent to this study.
Patients with history of eyelid or orbital surgery.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Takahashi |
Organization
Aichi Medical University
Division name
Ophthalmology
Zip code
4801195
Address
1-1, Yazako-Karimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
yasuhiro_tak@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Takahashi |
Organization
Aichi Medical University
Division name
Ophthalmology
Zip code
4801195
Address
1-1, Yazako-Karimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
Homepage URL
yasuhiro_tak@yahoo.co.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology in Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical University
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
Tel
0561623311
aichi-med@esct.bvits.com
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
愛知医科大学病院（愛知県）/ Aichi Medical University Hospital (Aichi)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 10 | 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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 04 | Day |
Last modified on
| 2023 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022695
