UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Predictability and Preoperative Factors of Cataract Surgery in Eyes with Keratoconus: a multi-center, retrospective clinical trial
Title of the study (Brief title)	Predictability and Preoperative Factors of Cataract Surgery in Eyes with Keratoconus: a multi-center, retrospective clinical trial
Region	Japan

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

Objectives
Narrative objectives1	Predictability of Cataract Surgery in Eyes with Keratoconus
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	refractive error
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	cataract surgery
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	cataract with Keratoconus
Key exclusion criteria	Low vision after cataract surgery;corrected distance visual acuity < 0.5
Target sample size	100

Research contact person
Name of lead principal investigator	Kazutaka Kamiya
Organization	University of Kitasato School of Medicine
Division name	Department of Ophthalmology
Address	1-15-1 Kitasato, Sagamihara, Kanagawa, 228-8555, Japan
TEL	0427789012
Email	kamiya-tky@umin.ac.jp

Public contact
Name of contact person	Kazutaka Kamiya
Organization	University of Kitasato School of Medicine
Division name	Department of Ophthalmology
Address	1-15-1 Kitasato, Sagamihara, Kanagawa, 228-8555, Japan
TEL	0427789012
Homepage URL
Email	kamiya-tky@umin.ac.jp

Sponsor
Institute	University of Kitasato School of Medicine
Institute
Department

Funding Source
Organization	University of Kitasato School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	2015 Year 07 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 01 Day
Anticipated trial start date	2015 Year 07 Month 01 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

Management information
Registered date	2015 Year 07 Month 26 Day
Last modified on	2017 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021161