UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035576
Receipt No. R000040535
Scientific Title Predictability of Intraocular Lens Power Calculation in Eyes Undergoing Phototherapeutic Keratectomy.
Date of disclosure of the study information 2019/01/17
Last modified on 2019/01/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Predictability of Intraocular Lens Power Calculation in Eyes Undergoing Phototherapeutic Keratectomy.
Acronym Predictability of Intraocular Lens Power Calculation in Eyes Undergoing Phototherapeutic Keratectomy.
Scientific Title Predictability of Intraocular Lens Power Calculation in Eyes Undergoing Phototherapeutic Keratectomy.
Scientific Title:Acronym Predictability of Intraocular Lens Power Calculation in Eyes Undergoing Phototherapeutic Keratectomy.
Region
Japan

Condition
Condition granular corneal dystrophy, band keratopathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the predictability of intraocular lens (IOL) power calculation using several corneal power measurements in eyes underwent phototherapeutic keratectomy (PTK).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes IOL power calculations were performed by the SRK/T formula using Total Corneal Refractive Power
Key secondary outcomes Automated keratometry, Simulated keratometry, True Net Power

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
65 years-old <=
Age-upper limit
88 years-old >=
Gender Male and Female
Key inclusion criteria total of 42 eyes of 25 consecutive patients
Key exclusion criteria Eyes with postoperative best spectacle-corrected visual acuity (BCVA) of >0.25 logMAR, and eyes with any history of ocular surgery, ocular trauma, or other concomitant eye diseases, were excluded from the study.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutaka Kamiya
Organization Kitasato University
Division name Ophthalmology
Zip code
Address 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0373, Japan
TEL +81-42-778-9012
Email kamiyak-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Yoneyama
Organization Kitasato University
Division name Ophthalmology
Zip code
Address 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0373, Japan
TEL +81-42-778-9012
Homepage URL
Email ryone.ry0@gmail.com

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization Kitasato University
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
Address
Tel
Email

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
2019 Year 01 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2018 Year 05 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Approval number:B17-362

Management information
Registered date
2019 Year 01 Month 17 Day
Last modified on
2019 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040535

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.