UMIN-CTR Clinical Trial

Basic information
Public title	Surgery for lower eyelid epiblepharon in children: a multi-center randomized controlled trial.
Acronym	Surgery for lower eyelid epiblepharon in children: a multi-center RCT.
Scientific Title	Surgery for lower eyelid epiblepharon in children: a multi-center randomized controlled trial.
Scientific Title:Acronym	Surgery for lower eyelid epiblepharon in children: a multi-center RCT.
Region	Japan

Condition
Condition	lower eyelid epiblepharon
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effectiveness and safety of the treatment result by the two types of surgical procedures between with performing a skin incision and without skin incision.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Cure rate (1 month and 6 months after surgical) The severity of keratopathy and ciliary touch by slit-lump examination.
Key secondary outcomes	Recurrence rate, therapeutic effect, corneal shape, refraction, cosmetic, and safety. The severity of keratopathy and ciliary touch by slit-lump examination, corneal topography, auto refract mater, optical coherence tomography and photography.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Suture method without skin incision
Interventions/Control_2	Modified Hotz procedure (with skin incision)
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	3 years-old <=
Age-upper limit	15 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who are 3 to 15 years of age with the keratopathy due to epiblepharon, who want to undergo a surgical treatment. When the ciliary touch is classified into three stages based on the previous report (Mild: contact with nasal conjunctiva, no corneal contact, Moderate: contact with nasal conjunctiva and cornea, Severe: contact with nasal conjunctiva, cornea and temporal conjunctiva), targeted to moderately relevant patients.
Key exclusion criteria	1. Patients with systemic syndrome. 2. Patients with facial anomalies / facial features abnormalities / eyelid tumors etc. that are thought to affect epiblepharon. 3. Patients who undergo surgery at the same time for upper epiblepharon or epicanthus. 4. Patients who have had a history of surgery on eyelids in the past. 5. Patients with abnormal lid closure, such as facial nerve paralysis, ptosis of the eyelids. 6. Traumatic epiblepharon. 7. Patients with keratoconjunctival disease not caused by epiblepharon. 8. Patients who can not respond to ophthalmologic examination mainly by slit lamp microscopy mainly due to the mental retardation. 9. Patients whose bleeding or scarring seems to be different from normal 10. Other patients who is unlikely to participate in the study, judge by the medical doctor.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Tomoko Middle name Last name Ohno
Organization	Yokohama City University
Division name	Ophthalmology
Zip code	2210825
Address	3 Chome-9 Fukuura, Kanazawa Ward, Yokohama, Kanagawa Prefecture
TEL	09091488439
Email	ochan_tt@yahoo.co.jp

Public contact
Name of contact person	1st name Tomoko Middle name Last name Ohno
Organization	Yokohama City University
Division name	Ophthalmology
Zip code	236-0004
Address	3 Chome-9 Fukuura, Kanazawa Ward, Yokohama, Kanagawa Prefecture
TEL	045-787-2683
Homepage URL
Email	ochan_tt@yahoo.co.jp

Sponsor
Institute	Yokohama City University Department of Ophthalmology
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kanagawa Children's Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University for Novel and Exploratory Clinical Trials
Address	3 Chome-9 Fukuura, Kanazawa Ward, Yokohama, Kanagawa Prefecture
Tel	045-787-2800
Email	nextjim1@yokohama-cu.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

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 12 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	50
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	2017 Year 04 Month 01 Day
Date of IRB	2017 Year 03 Month 21 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 12 Day
Last modified on	2020 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029014