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
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
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
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
