UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000035576
Receipt number 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 21:12:44

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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 or person

Institute

Kitasato University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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