UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036108
Receipt number R000041133
Scientific Title Quantitative analysis of effect on corneal epithelial recovery and visual quality using platelet-rich plasma for corneal erosion.
Date of disclosure of the study information 2019/03/06
Last modified on 2020/03/06 09:49:30

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Basic information

Public title

Quantitative analysis of effect on corneal epithelial recovery and visual quality using platelet-rich plasma for corneal erosion.

Acronym

corneal epithelial recovery and visual quality using platelet-rich plasma for corneal erosion

Scientific Title

Quantitative analysis of effect on corneal epithelial recovery and visual quality using platelet-rich plasma for corneal erosion.

Scientific Title:Acronym

corneal epithelial recovery and visual quality using platelet-rich plasma for corneal erosion

Region

Japan


Condition

Condition

Corneal erosion

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the efficacy of PRP treatment for corneal erosion after PTK

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Area of corneal erosion

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

Candidates for phototherapeutic keratectomy in eyes with granular corneal dystrophy and band keratopathy.

Key exclusion criteria

Eyes with other ophthalmic diseases such as keratoconus.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Kazutaka
Middle name
Last name Kamiya

Organization

Kitasato University

Division name

School of Allied Health Science

Zip code

2520373

Address

1-15-1 Kitasato, Minami, Sagamihara, Kanagawa

TEL

0427788464

Email

kamiyak-tky@umin.ac.jp


Public contact

Name of contact person

1st name Kazutaka
Middle name
Last name Kamiya

Organization

Kitasato University

Division name

School of Allied Health Science

Zip code

2520373

Address

1-15-1 Kitasato, Minami, Sagamihara, Kanagawa

TEL

0427788464

Homepage URL


Email

kamiyak-tky@umin.ac.jp


Sponsor or person

Institute

Kitasato University

Institute

Department

Personal name



Funding Source

Organization

Kitasato University

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

Kitasato University

Address

1-15-1 Kitasato, Minami, Sagamihara, Kanagawa

Tel

0427788464

Email

kamiyak-tky@umin.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



Other administrative information

Date of disclosure of the study information

2019 Year 03 Month 06 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

Completed

Date of protocol fixation

2019 Year 02 Month 01 Day

Date of IRB

2019 Year 09 Month 30 Day

Anticipated trial start date

2019 Year 03 Month 31 Day

Last follow-up date

2020 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Time points
Before PTK, 1,3,5,7 days and 1 month after PTK
Measurement Outcomes
Visual acuity
Refraction
Area of corneal erosion
Score of staining for corneal and conjunctival epithelium
Questionnaire of subjective symptoms
Patient Satisfaction
Corneal topography
Complications


Management information

Registered date

2019 Year 03 Month 06 Day

Last modified on

2020 Year 03 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041133


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name