UMIN-CTR Clinical Trial

Basic information
Public title	Improvement in Visual Function and Patient Satisfaction with Various Contact Lenses
Acronym	Improvement in Visual Function and Patient Satisfaction with Various Contact Lenses
Scientific Title	Improvement in Visual Function and Patient Satisfaction with Various Contact Lenses
Scientific Title:Acronym	Improvement in Visual Function and Patient Satisfaction with Various Contact Lenses
Region	Japan Australia

Condition
Condition	Corneal Irregularities
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In patients with corneal disease and prescribed HCL at our institution and at Innovative Eyecare (Adelaide, Australia), the type, size, and material of HCLs were reviewed backward from the medical records for visual acuity, corneal shape, aberrations, daily vision, and patient satisfaction, as well as the effect on visual function. The aim of this study is to identify the factors that give The findings from this study are expected to further improve the accuracy of visual function in HCL in ocular corneal disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the type, size, and material of HCLs visual acuity corneal shape aberrations vision patient satisfaction
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	18 years-old <=
Age-upper limit	39 years-old >=
Gender	Male and Female
Key inclusion criteria	Corneal Irregularities
Key exclusion criteria	Intraocular Surgery Eye diseases such as allergies
Target sample size	100

Research contact person
Name of lead principal investigator	1st name YUKINOBU Middle name Last name OKAJIMA
Organization	Toho University Omori medical center
Division name	Ophthalmology
Zip code	143-8451
Address	6-11-1 omorinishi otaku tokyo
TEL	03-3762-4151
Email	yukinobu.okajima@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Yukinobu Middle name Last name Okajima
Organization	Toho University Omori medical center
Division name	Ophthalmology
Zip code	143-8451
Address	6-11-1 omorinishi otaku tokyo
TEL	03-3762-4151
Homepage URL
Email	yukinobu.okajima@med.toho-u.ac.jp

Sponsor
Institute	Toho university
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	Toho University Omori medical center
Address	6-11-1 omorinishi otaku
Tel	03-3762-4151
Email	yukinobu.okajima@med.toho-u.ac.jp

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	東邦大学医療センター大森病院, Innovative eye care

Other administrative information
Date of disclosure of the study information	2020 Year 11 Month 25 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	55
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	Main results already published
Date of protocol fixation	2020 Year 11 Month 25 Day
Date of IRB	2020 Year 09 Month 10 Day
Anticipated trial start date	2020 Year 11 Month 25 Day
Last follow-up date	2021 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2020 Year 11 Month 25 Day
Last modified on	2020 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048571