UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010500 |
|---|---|
| Receipt number | R000012273 |
| Scientific Title | Incidence of deepening of the upper eyelid sulcus caused by opening eyes wide |
| Date of disclosure of the study information | 2013/04/15 |
| Last modified on | 2013/12/08 13:15:47 |
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Basic information
Public title
Incidence of deepening of the upper eyelid sulcus caused by opening eyes wide
Acronym
Incidence of deepening of the upper eyelid sulcus caused by opening eyes wide
Scientific Title
Incidence of deepening of the upper eyelid sulcus caused by opening eyes wide
Scientific Title:Acronym
Incidence of deepening of the upper eyelid sulcus caused by opening eyes wide
Region
| Japan |
Condition
Condition
1 Healthy volunteers
2 Patients with blepharoptosis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the incidence of DUES by opening eyes wide
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of DUES
Key secondary outcomes
The wrinkles on the brow
MRD
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Younger and older healthy subjects
2 Patients with blepharoptosis
Key exclusion criteria
1 Subjects with any ocular diseases
2 Patients with previous blepharoptosis surgery
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Nakakura |
Organization
Saneikai Tsukazaki Hospital
Division name
Department of ophthalmology
Zip code
Address
Himeji city Aboshi waku 68-1
TEL
+81-79-272-8555
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Nakakura |
Organization
Saneikai Tsukazaki Hospital
Division name
Department of ophthalmology
Zip code
Address
TEL
+81-79-272-8555
Homepage URL
Sponsor or person
Institute
Saneikai Tsukazaki Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 15 | 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
Our results indicated that wide-open eyes can cause a DUES-like appearance. Blepharoptosis itself is not a predictive factor; however, clinicians should take care not to overestimate DUES, especially in patients with UES with natural-open eyes, because a DUES-like appearance can be caused by wide-open eyes, even in treatment-naive patients.
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
| 2013 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 10 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 08 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 08 | Day |
Other
Other related information
DUES are evaluated by three observer using photographs.
Management information
Registered date
| 2013 | Year | 04 | Month | 15 | Day |
Last modified on
| 2013 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012273
