UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030230 |
|---|---|
| Receipt number | R000034529 |
| Scientific Title | Diagnosis of dry eye subtype by artificial intelligence software based on the interferometric fringe pattern of the tear film obtained with the Kowa DR-1a instrument |
| Date of disclosure of the study information | 2017/12/02 |
| Last modified on | 2017/12/02 13:03:51 |
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Basic information
Public title
Diagnosis of dry eye subtype by artificial intelligence software based on the interferometric fringe pattern of the tear film obtained with the Kowa DR-1a instrument
Acronym
Diagnosis of dry eye subtype by artificial intelligence software with DR-1a
Scientific Title
Diagnosis of dry eye subtype by artificial intelligence software based on the interferometric fringe pattern of the tear film obtained with the Kowa DR-1a instrument
Scientific Title:Acronym
Diagnosis of dry eye subtype by artificial intelligence software with DR-1a
Region
| Japan |
Condition
Condition
healthy volunteers and dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We previously showed that the DR-1a tear interferometer (Kowa) has the potential to identify subtypes of dry eye on the basis of classification of interferometric fringe patterns as pearl-like appearance (normal tear condition), Jupiter-like appearance (aqueous-deficient dry eye), or crystal-like appearance (evaporative dry eye). We here set out to develop and validate automatic diagnosis software for analysis of tear interferometric fringe patterns obtained with DR-1a.
Basic objectives2
Others
Basic objectives -Others
The agreement between the clinical diagnosis, AI-diagnosis, and IF-diagnosis is assessed, and the F-score was calculated as a measure of the accuracy, considering both precision and recall, of AI-diagnosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Non-invasive breakup time
Kappa value
F score
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy volunteers
dry eye patients
Key exclusion criteria
Contact lens wearers
Systemic diseases which might interfere with tear secretion
the history of ocular surgery
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Reiko Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
Address
626-11, Minaminakano, Minuma-ku, Saitama City, Saitama
TEL
048-686-5588
ritoh@za2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Reiko Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
Address
626-11, Minaminakano, Minuma-Ku, Saitama,
TEL
048-686-5588
Homepage URL
ritoh@za2.so-net.ne.jp
Sponsor or person
Institute
Itoh Clinic, Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Itoh Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
collecting the data including both aqueous deficiency and evaporative dry eye
Management information
Registered date
| 2017 | Year | 12 | Month | 02 | Day |
Last modified on
| 2017 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034529
