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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name