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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031737
Receipt No. R000036237
Scientific Title Evaluating the efficiency of Custom-made Scleral Contact lens for severe limbal stem cell deficiency.
Date of disclosure of the study information 2018/03/15
Last modified on 2019/03/17

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Basic information
Public title Evaluating the efficiency of Custom-made Scleral Contact lens for severe limbal stem cell deficiency.
Acronym Evaluating the efficiency of Custom-made Scleral Contact lens
Scientific Title Evaluating the efficiency of Custom-made Scleral Contact lens for severe limbal stem cell deficiency.
Scientific Title:Acronym Evaluating the efficiency of Custom-made Scleral Contact lens
Region
Japan

Condition
Condition Severe limbal stem cell deficiency.
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In patients with severe stem cell deficiency,the long-term prognosis of penetrating keratoplasty,lamelar keratoplasty,and limbal transplantation is for,and the severe corneal opacity leads to severe visual dysfunction.
To date,there is no standardized treatment to obtain visual improvement in case soft every stem cell deficiency,
We developed a gimbal supported scleral contact lens used non-surgical method.
The aim of this study was to evaluate the efficacy of custom-maid scleral lens for severe limbal stem cell deficiency.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The best corrective visual acuity with scleral lens.

Key secondary outcomes The pollution of contact lens.
The time and frequency of contact lens -wearing
The change of anterior and posterior curve of cornea with scleral lens wearing.

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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 We check the corrective visual acuity with scleral lens in every 3-6 month.
We ask the condition about the use of of lens with in every 3-6 month.
We measured the curve of cornea by corneal topography in every 3-6 month.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patient who can continue using the scleral lens for severe stem cell deficiency includingSteven-Jhonsons=syndrome.
Over 16 years old.
Key exclusion criteria Under 15 years old
the patient who judged as inappropriate for this study.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Chie
Middle name
Last name Sotozono
Organization Kyoto prefectural university of medicine
Division name Ophthalmology
Zip code 602-8566
Address 465 kajiicho kamigyoku kyoto japan
TEL 075-251-5578
Email csotozon@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Chie
Middle name
Last name Sotozono
Organization Kyoto peprfectual university of medicine
Division name Ophthalmology
Zip code 602-8566
Address 465 kajiicho kamigyoku kyoto japan
TEL 075-251-5578
Homepage URL
Email csotozon@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto peprfectual university of medicine
Institute
Department

Funding Source
Organization SUN CONTACT Co
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto Prefectural University of Medicine, Clinical Research Review Board
Address 465 Kajiicho Kamigyo-ku Kyoto
Tel 075-251-5337
Email rinri@koto.kpu-m.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
2018 Year 03 Month 15 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 10 Month 25 Day
Date of IRB
2010 Year 01 Month 15 Day
Anticipated trial start date
2017 Year 10 Month 25 Day
Last follow-up date
2021 Year 03 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
2018 Year 03 Month 15 Day
Last modified on
2019 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036237

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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