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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017200
Receipt No. R000019945
Scientific Title The clinical results of treatment of thyroid eye disease.
Date of disclosure of the study information 2015/04/20
Last modified on 2015/04/20

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Basic information
Public title The clinical results of treatment of thyroid eye disease.
Acronym The clinical results of treatment of thyroid eye disease.
Scientific Title The clinical results of treatment of thyroid eye disease.
Scientific Title:Acronym The clinical results of treatment of thyroid eye disease.
Region
Japan

Condition
Condition treatment of thyroid eye disease patient.
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the clinical influence of thyroid eye therapy.
Basic objectives2 Others
Basic objectives -Others To study visual acuity function and clinical influence with thyroid eye therapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The Axial length, corneal curvature, the curvature of the retina, anterior chamber depth, aberation,retinal thickness, choloidal thickness, anatomical changes of the eye, and the function of visual acuity before phakic IOL implantation are compared with those after therapy.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Thyroid eye disease patients
Key exclusion criteria Subject with any other ocular disease and surgeries
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Santaro Noguchi
Organization Saneikai Tsukazaki Hospital
Division name Department of Ophthalmology
Zip code
Address 68-1, Waku, Aboshi-ku, Himeji, Hyogo Prefecture, Japan
TEL 079-272-8555
Email s.noguchi@tsukazaki-eye.net

Public contact
Name of contact person
1st name
Middle name
Last name Noguchi Santaro
Organization Saneikai Tsukazaki Hospital
Division name Department of Ophthalmology
Zip code
Address 68-1, Waku, Aboshi-ku, Himeji, Hyogo Prefecture, Japan
TEL 079-272-8555
Homepage URL
Email s.noguchi@tsukazaki-eye.net

Sponsor
Institute Saneikai Tsukazaki Hospital
Institute
Department

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

Other related organizations
Co-sponsor
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
2015 Year 04 Month 20 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
2015 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Axial length measurement, Keratometer, aberration analysis, optical Coherence Tomography analysis, the intraocular pressure1, imaging test and visual acuity analysis are performed before and after therapy.

Management information
Registered date
2015 Year 04 Month 20 Day
Last modified on
2015 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019945

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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