UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027321
Receipt No. R000029014
Scientific Title Surgery for lower eyelid epiblepharon in children: a multi-center randomized controlled trial.
Date of disclosure of the study information 2017/05/12
Last modified on 2018/11/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Tomoko Ohno
Organization Yokohama City University
Division name Ophthalmology
Zip code
Address 3 Chome-9 Fukuura, Kanazawa Ward, Yokohama, Kanagawa Prefecture
TEL 045-787-2683
Email ochan_tt@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Ohno
Organization Yokohama City University
Division name Ophthalmology
Zip code
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
Address
Tel
Email

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
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
2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 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
2017 Year 05 Month 12 Day
Last modified on
2018 Year 11 Month 16 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.