UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027321
Receipt number 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 2020/07/30 09:05:45

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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 or person

Institute

Yokohama City University
Department of Ophthalmology

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

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

Value
https://center6.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