UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Reiko Arita
Organization	Itoh Clinic
Division name	Ophthalmology
Address	626-11, Minaminakano, Minuma-ku, Saitama City, Saitama
TEL	048-686-5588
Email	ritoh@za2.so-net.ne.jp

Public contact
Name of contact person	Reiko Arita
Organization	Itoh Clinic
Division name	Ophthalmology
Address	626-11, Minaminakano, Minuma-Ku, Saitama,
TEL	048-686-5588
Homepage URL
Email	ritoh@za2.so-net.ne.jp

Sponsor
Institute	Itoh Clinic, Department of Ophthalmology
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 11 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034529