UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035683 |
|---|---|
| Receipt number | R000040647 |
| Scientific Title | The change of meibomian gland after post-levator-resection in patients with aponeurotic ptosis |
| Date of disclosure of the study information | 2019/01/28 |
| Last modified on | 2021/01/27 14:02:19 |
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Basic information
Public title
The change of meibomian gland after post-levator-resection in patients with aponeurotic ptosis
Acronym
The change of meibomian gland after post-levator-resection
Scientific Title
The change of meibomian gland after post-levator-resection in patients with aponeurotic ptosis
Scientific Title:Acronym
The change of meibomian gland after post-levator-resection
Region
| Japan |
Condition
Condition
aponeurotic ptosis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluate of change of photographs of lid margin and meibomian gland photographs using noncontact infrared meibograpy, and the score grading scales of meibomian gland dysfunction (MGD) between preoperative and after post-levator-resection in patients with aponeurotic ptosis
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate of the change of photographs of lid margin and meibomian gland photographs, grading scale for MGD after post-levator-resection
Key secondary outcomes
Tear break up time, superficial punctate keratopathy
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Before surgery: taking photographs of lid margin, meibography, and break up time (BUT).
Surgery: levator resection.
3 months after surgery: taking photographs of lid margin, meibography, and BUT.
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 with blepharoptosis
Key exclusion criteria
Patients with previous blepharoptosis surgery.
Patients with thyroid disease.
Patients with facial nerve palsy.
Patients with severe dry eye disease and blepharitis.
Patients with non-aponeurotic ptosis.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshie |
| Middle name | |
| Last name | Shimizu |
Organization
Saneikai Tsukazaki Hospital
Division name
Department of ophthalmology
Zip code
671-1227
Address
Himeji city Aboshi Waku 68-1
TEL
0792728555
Yo.shimizu@tsukazaki-eye.net
Public contact
Name of contact person
| 1st name | Yoshie |
| Middle name | |
| Last name | Shimizu |
Organization
Saneikai Tsukazaki Hospital
Division name
Department of ophthalmology
Zip code
671-1227
Address
Himeji city Aboshi Waku 68-1
TEL
+81-79-272-8555
Homepage URL
Yo.shimizu@tsukazaki-eye.net
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
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Saneikai Tsukazaki Hospital
Address
Himeji city Aboshi Waku 68-1
Tel
0792728555
Yo.shimizu@tsukazaki-eye.net
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
| 2019 | Year | 01 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 26 | Day |
Last modified on
| 2021 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040647
