UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004256 |
|---|---|
| Receipt number | R000004990 |
| Scientific Title | Prospective controlled study of the utility of Ocular Surface Thermography for diagnosis and treatment of ocular diseases. |
| Date of disclosure of the study information | 2010/09/23 |
| Last modified on | 2015/03/24 08:34:25 |
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Basic information
Public title
Prospective controlled study of the utility of Ocular Surface Thermography for diagnosis and treatment of ocular diseases.
Acronym
Utility of Ocular Surface Thermography for diagnosis and treatment of ocular diseases.
Scientific Title
Prospective controlled study of the utility of Ocular Surface Thermography for diagnosis and treatment of ocular diseases.
Scientific Title:Acronym
Utility of Ocular Surface Thermography for diagnosis and treatment of ocular diseases.
Region
| Japan |
Condition
Condition
Ocular diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To use measurements of ocular surface temperature obtained by Ocular Surface Thermography in order to diagnose, treat, and elucidate the mechanisms of pathological conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Collection of data from normal subjects
2. Temperature changes due to dry eye
3. Changes in the surface temperature of filtering blebs after surgical treatment for glaucoma (trabeculectomy)
4. Temperature changes influenced by insertion, removal or changes in contact lenses
5. Temperature changes in degenerative disorders of the cornea or conjunctiva
6. Temperature changes in infectious or inflammatory ocular diseases
7. Temperature changes after laser treatments (especially iridotomy)
8. Temperature changes after invasive surgery (cataract, vitreous body, cornea, conjunctiva, glaucoma)
9. Temperature changes in chronic glaucoma
Ocular surface temperature will be measured and recorded, and values will be calculated for various regions of the cornea and conjunctiva (temporal, nasal, superior, inferior) and ocular lesions. Values for outcomes 1-9 will be analyzed to determine whether they can be used for diagnosis of ocular diseases, and whether they reflect the severity of pathology or degree of recovery.
Key secondary outcomes
Verify device safety
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Normal subjects
2. Dry eye
3. Post-glaucoma surgery
4. Contact lens users
5. Degenerative diseases of the cornea or conjunctiva
6. Infectious or inflammatory ocular diseases
7. Post-laser treatment (especially iridotomy)
8. Post-invasive surgery (cataract, vitreous body, cornea, conjunctiva, glaucoma)
9. Chronic glaucoma
Key exclusion criteria
This thermography device is non-invasive, but subjects who feel stress as a result of the Ocular Surface Thermography examination, or those who experience an allergic reaction or foreign body sensation during eye drop instillation will be excluded from the study.
Target sample size
550
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiro Kawasaki |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Shitsukawa, Toon, Ehime 791-0295, Japan
TEL
089-960-5361
kawasaki.eye.clinic@ray.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Shiraishi |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Shitsukawa, Toon, Ehime 791-0295, Japan
TEL
089-960-5361
Homepage URL
shiraia@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Ehime University
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
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
愛媛大学医学部付属病院（愛媛県） Ehime University Hospital (Ehime Prefecture)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The decrease in the ocular surface
temperature in dry eyes was significantly greater than that in normal eyes (P < .001) at 10 seconds after eye opening.
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
Main results already published
Date of protocol fixation
| 2007 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
We found that Ocular Surface Thermography is useful for diagnosis of dry eye, and are in the process of submitting a journal article regarding our results.
Management information
Registered date
| 2010 | Year | 09 | Month | 22 | Day |
Last modified on
| 2015 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004990
