UMIN-CTR Clinical Trial

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
Email	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
Email	Yo.shimizu@tsukazaki-eye.net

Sponsor
Institute	Saneikai Tsukazaki Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040647