UMIN-CTR Clinical Trial

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

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014774
Receipt No. R000017178
Official scientific title of the study Evaluation of ocular pathological condition using polarization-sensitive optical coherence tomography
Date of disclosure of the study information 2014/08/06
Last modified on 2014/08/06

* 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
Official scientific title of the study Evaluation of ocular pathological condition using polarization-sensitive optical coherence tomography
Title of the study (Brief title) Evaluation of ocular diseases using PS-OCT
Region
Japan

Condition
Condition Glaucoma, Glaucoma after trabeculectomy, Keratoconus, Corneal dystrophy, Pterygium, Inflammatory anterior eye diseases, Cataract
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study effectiveness of PS-OCT to elucidation, early diagnosis, and follow-up after surgery of ocular diseases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Phase retardation calculated by PS-OCT
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients obtained informed consent and already diagnosed are included.
Key exclusion criteria The patients that are not obtained informed consent, are pregnant, and have the systemic diseases and past medical history affect ocular fibrous structure are excluded.
Target sample size 180

Research contact person
Name of lead principal investigator Toru Nakazawa
Organization Tohoku University Graduate School of Medicine
Division name Ophthalmology
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL +81-22-717-7294
Email ntoru@oph.med.tohoku.ac.jp

Public contact
Name of contact person Satoru Tsuda
Organization Tohoku University Graduate School of Medicine
Division name Ophthalmology
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL +81-22-717-7294
Homepage URL
Email tsuda@oph.med.tohoku.ac.jp

Sponsor
Institute Department of Ophthalmology, Tohoku University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Department of Ophthalmology, Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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
2014 Year 08 Month 06 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2013 Year 12 Month 01 Day
Anticipated trial start date
2013 Year 12 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Prospective study

Management information
Registered date
2014 Year 08 Month 06 Day
Last modified on
2014 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017178


Contact us.