UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044107
Receipt number R000050356
Scientific Title Comparison of Visual and Refractive Outcomes of Hyperopia Correcting-PTK and Conventional PTK
Date of disclosure of the study information 2021/05/08
Last modified on 2023/05/07 12:47:50

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Basic information

Public title

Comparison of Visual and Refractive Outcomes of Hyperopia Correcting-PTK and Conventional PTK

Acronym

Comparison of Hyperopia Correcting-PTK and Conventional PTK

Scientific Title

Comparison of Visual and Refractive Outcomes of Hyperopia Correcting-PTK and Conventional PTK

Scientific Title:Acronym

Comparison of Hyperopia Correcting-PTK and Conventional PTK

Region

Japan


Condition

Condition

corneal dystrophy

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

compare HC-PTK and conventional PTK

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

refraction

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

We retrospectively evaluated patients who underwent HC-PTK and conventional PTK for granular corneal dystrophy or band keratopathy.

Key exclusion criteria

none

Target sample size

69


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 Sciences

Zip code

2520375

Address

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

TEL

042-778-8111

Email

kamiyak-tky@umin.ac.jp


Public contact

Name of contact person

1st name Hideki
Middle name
Last name Hayakawa

Organization

Kitasato University

Division name

school of medicine

Zip code

2520375

Address

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

TEL

042-778-8111

Homepage URL


Email

m09088w@st.kitasato-u.ac.jp


Sponsor or person

Institute

Kitasato University Hospital

Institute

Department

Personal name



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

Kitasato University Hospital

Address

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

Tel

042-778-8273

Email

rinrib@med.kitasato-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



Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 08 Day


Related information

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/35355603/

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/35355603/

Number of participants that the trial has enrolled

49

Results

https://pubmed.ncbi.nlm.nih.gov/35355603/

Results date posted

2023 Year 05 Month 07 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

https://pubmed.ncbi.nlm.nih.gov/35355603/

Participant flow

https://pubmed.ncbi.nlm.nih.gov/35355603/

Adverse events

none

Outcome measures

https://pubmed.ncbi.nlm.nih.gov/35355603/

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2019 Year 03 Month 26 Day

Date of IRB

2019 Year 03 Month 26 Day

Anticipated trial start date

2019 Year 04 Month 01 Day

Last follow-up date

2021 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete

2021 Year 11 Month 30 Day

Date analysis concluded

2022 Year 11 Month 01 Day


Other

Other related information

none


Management information

Registered date

2021 Year 05 Month 05 Day

Last modified on

2023 Year 05 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050356


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name