UMIN-CTR Clinical Trial

Basic information
Public title	Tear evaluation before and after eye surgery by idora
Acronym	Tear evaluation before and after eye surgery by idora
Scientific Title	Tear evaluation before and after eye surgery by idora
Scientific Title:Acronym	Tear evaluation before and after eye surgery by idora
Region	Japan

Condition
Condition	Cataract, retinal surgery
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To analyze changes in tear due to surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	higher-order corneal aberration, idra, meniscus, BUT, corneal punctate superficial keratitis
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	Patients of receiving cataract or retinal surgery
Key exclusion criteria	Another eye disease of catarct and retinal disease
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Santaro Middle name Last name Noguchi
Organization	Tsukazaki Hospital
Division name	OphthalmologO
Zip code	671-1227
Address	Waku, 68-1
TEL	09037507658
Email	n_santa_pl0_0lq@hotmail.com

Public contact
Name of contact person	1st name Santaro Middle name Noguchi Last name Noguchi
Organization	Tsukazaki Hospital
Division name	OphthalmologO
Zip code	671-1227
Address	Waku, 68-1
TEL	0792728555
Homepage URL
Email	n.santar0721@gmail.com

Sponsor
Institute	Tsukazaki Hospital
Institute
Department

Funding Source
Organization	Tsukazaki Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tsukazaki Hospital
Address	Waku, 68-1
Tel	0792728555
Email	n_santa_pl0_0lq@hotmail.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	2021 Year 05 Month 30 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	Terminated
Date of protocol fixation	2020 Year 09 Month 12 Day
Date of IRB	2020 Year 10 Month 20 Day
Anticipated trial start date	2020 Year 10 Month 21 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observation

Management information
Registered date	2020 Year 10 Month 27 Day
Last modified on	2021 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048228