UMIN-CTR Clinical Trial

Basic information
Public title	Early diagnosis of keratoconus using test value by auto keratometer.
Acronym	Early diagnosis of keratoconus using auto keratometer.
Scientific Title	Early diagnosis of keratoconus using test value by auto keratometer.
Scientific Title:Acronym	Early diagnosis of keratoconus using auto keratometer.
Region	Japan

Condition
Condition	Keratoconus
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate possibility of diagnosing early keratoconus using test value from auto keratometer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Choose keratoconus which was examined during the target period from insurance names of diseases, confirm that it is keratoconus by using corneal shape analysis, enter the parameters of age, sex, measured value of keratometer and corneal shape analysis (corneal topography or anterior segment OCT) into the excel data. For normal subject select the patient with normal corneal shape who visited Nagoya Eye Clinic or Sato Yuya Eye Clinic for the purpose of refraction surgery, then enter the excel data as well. Data will be accumulated at Nagoya Eye Clinic. When data from all facility were collected patients data will be randomly divided into two, and a group will be regression formula group for prediction probability of keratoconus. The other group will assess the fidelity of regression formula. For group one analysis dependent variable will be early keratoconus or normal, independent variable will be keratometer value (average K value, flat K value, steep K value, astigmatic power, astigmatic axis), do logistic regression analysis, then calculate the cut-off value. To calculate the cut-off value determine the parameter value when the value of [sensitivity-(1- specificity)] is greatest(Youden Index).By using the determined regression formula assess the fidelity of regression formula determined in group one, by group two to calculate sensitivity and specificity.
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	10 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient diagnosed to be keratoconus by corneal shape analysis device (corneal topography or cornea tomography)
Key exclusion criteria	Patient who also have corneal disease other than keratoconus.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Kojima
Organization	Nagoya Eye Clinic
Division name	Ophthalmology
Zip code	456-0003
Address	3F Meitetsu Kanayama Daiichi Bldg 25-1 Namiyose cho, Atsuta-ku, Nagoya, Aichi
TEL	0120-758-0490
Email	kojima@chukyogroup.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Kojima
Organization	Nagoya Eye Clinic
Division name	Ophthalmology
Zip code	456-0003
Address	3F Meitetsu Kanayama Daiichi Bldg 25-1 Namiyose cho, Atsuta-ku, Nagoya, Aichi
TEL	0120-758-0490
Homepage URL
Email	sawada@lasik.ne.jp

Sponsor
Institute	Nagoya Eye Clinic
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	a
Address	a
Tel	a
Email	aa

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	ＪＣＨＯ中京病院（愛知県）、名古屋アイクリニック（愛知県）、飯田市立病院（長野県）、佐藤裕也眼科医院（宮城県）、岐阜赤十字病院（岐阜県）

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 01 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/32114181/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/32114181/
Number of participants that the trial has enrolled	328
Results	Sensitivity and specificity of KKI were 85.0% and 86.7%, respectively.
Results date posted	2021 Year 04 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	123 patients/eyes in the keratoconus group: average age 26.36 +- 8.68 years, 84 men, 39 women, 205 patients/eyes in the control group: 26.20 +- 7.34 years, 139 men, 66 women
Participant flow	123 patients/eyes in the keratoconus group and 205 patients/eyes in the control group were enrolled. Since this is a retrospective study, there is no random allocation.
Adverse events	none
Outcome measures	As a result of logistic regression analysis, the selected dependent variables were steeper meridian K value (partial regression coefficient 1.284, odds ratio 3.610), flatter meridian K value (partial regression coefficient -0.618, odds ratio 0.539), and direct astigmatism (partial regression coefficient -3.163 and the odds ratio 0.042). AUROC was 0.90, which was significantly higher than when each parameter was used alone (P <0.001). The sensitivity and specificity of the Keratometer Keratoconus Index (KKI) prepared from the test values of the autokeratometer created by the results of logistic regression analysis were 85.0% and 86.7%, respectively.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 06 Month 01 Day
Date of IRB	2018 Year 07 Month 11 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date	2019 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Choose keratoconus which was examined during the target period from insurance names of diseases, confirm that it is keratoconus by using corneal shape analysis, enter the parameters of age, sex, measured value of keratometer and corneal shape analysis (corneal topography or anterior segment OCT) into the excel data. For normal subject select the patient with normal corneal shape who visited Nagoya Eye Clinic or Sato Yuya Eye Clinic for the purpose of refraction surgery, then enter the excel data as well. Data will be accumulated at Nagoya Eye Clinic. When data from all facility were collected patients data will be randomly divided into two, and a group will be regression formula group for prediction probability of keratoconus. The other group will assess the fidelity of regression formula. For group one analysis dependent variable will be early keratoconus or normal, independent variable will be keratometer value (average K value, flat K value, steep K value, astigmatic power, astigmatic axis), do logistic regression analysis, then calculate the cut-off value. To calculate the cut-off value determine the parameter value when the value of [sensitivity-(1- specificity)] is greatest(Youden Index).By using the determined regression formula assess the fidelity of regression formula determined in group one, by group two to calculate sensitivity and specificity.

Management information
Registered date	2019 Year 04 Month 01 Day
Last modified on	2021 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038054