UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036372 |
|---|---|
| Receipt number | R000038054 |
| Scientific Title | Early diagnosis of keratoconus using test value by auto keratometer. |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2021/04/05 10:32:39 |
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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
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
sawada@lasik.ne.jp
Sponsor or person
Institute
Nagoya Eye Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038054
