UMIN-CTR Clinical Trial

Basic information
Public title	Prediction of the refraction after cataract surgery using artificial intelligence
Acronym	Prediction of the refraction after cataract surgery using artificial intelligence
Scientific Title	Prediction of the refraction after cataract surgery using artificial intelligence
Scientific Title:Acronym	Prediction of the refraction after cataract surgery using artificial intelligence
Region	Japan

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

Objectives
Narrative objectives1	To predict the refraction after cataract surgery using artificial intelligence
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Refractive error after cataract surgery
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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Cases with required test results before and after cataract surgery
Key exclusion criteria	Postoperative corrected visual acuity less than 0.8
Target sample size	1000

Research contact person
Last name of lead principal investigator	1st name Tomofusa Middle name Last name Yamauchi
Organization	Tsukazaki Hospital
Division name	Ophthalmology
Zip code	671-1227
Address	68-1, Waku, Aboshi-ku, Himeji, 671-1227, Japan
TEL	+81792728555
Email	tomofusa.yamauchi@gmail.com

Public contact
1st name of contact person	1st name Yamauchi Middle name Last name Tomofusa
Organization	Tsukazaki Hospital
Division name	Ophthalmology
Zip code	671-1227
Address	68-1, Waku, Aboshi-ku, Himeji, 671-1227, Japan
TEL	+81792728555
Homepage URL
Email	tomofusa.yamauchi@gmail.com

Sponsor
Institute	Tsukazaki Hospital
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	Tsukazaki Hospital
Address	68-1, Waku, Aboshi-ku, Himeji, 671-1227, Japan
Tel	+81792728555
Email	tomofusa.yamauchi@gmail.com

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	2018 Year 10 Month 15 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	No longer recruiting
Date of protocol fixation	2018 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date	2018 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To predict postoperative refraction from parameters before cataract surgery.

Management information
Registered date	2018 Year 10 Month 15 Day
Last modified on	2019 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039333