UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008112
Receipt number R000009549
Scientific Title Clinical Results of the Corneal Surgery Using Excimer Laser and Femtosecond Laser
Date of disclosure of the study information 2012/06/21
Last modified on 2023/12/15 16:08:17

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Basic information

Public title

Clinical Results of the Corneal Surgery Using Excimer Laser and Femtosecond Laser

Acronym

Clinical Results of the Laser Corneal Surgery

Scientific Title

Clinical Results of the Corneal Surgery Using Excimer Laser and Femtosecond Laser

Scientific Title:Acronym

Clinical Results of the Laser Corneal Surgery

Region

Japan


Condition

Condition

corneal disease, refractive error

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To evaluate the results of the laser corneal surgery

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

visual acuity

Key secondary outcomes

satisfaction rate of a patient


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

1 years-old <=

Age-upper limit

110 years-old >

Gender

Male and Female

Key inclusion criteria

The Eyes that were performed Laser Corneal Surgery

Key exclusion criteria

The patients who were followed-up for less than 1 month after the Laser surgery

Target sample size

10000


Research contact person

Name of lead principal investigator

1st name Osamu
Middle name
Last name Hieda

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Ophthalmology

Zip code

602-0841

Address

465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto , Japan

TEL

075-251-5578

Email

oheida@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Osamu
Middle name
Last name Hieda

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Ophthalmology

Zip code

602-0841

Address

465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto , Japan

TEL

075-251-5578

Homepage URL


Email

oheida@koto.kpu-m.ac.jp


Sponsor or person

Institute

Department of Ophthalmology, Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Ophthalmology, Kyoto Prefectural University of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Baptist Eye Clinic

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto Prefectural University of Medicine

Address

Kji-cho 465

Tel

0752515578

Email

ohieda@koto.kpu-m.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

2012 Year 06 Month 21 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

400

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

No longer recruiting

Date of protocol fixation

2012 Year 06 Month 20 Day

Date of IRB

2012 Year 07 Month 10 Day

Anticipated trial start date

2012 Year 07 Month 11 Day

Last follow-up date

2027 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2027 Year 03 Month 31 Day

Date analysis concluded

2028 Year 03 Month 31 Day


Other

Other related information

uncorrected visual acuity, corrected visual acuity, patient's satisfaction rate


Management information

Registered date

2012 Year 06 Month 06 Day

Last modified on

2023 Year 12 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009549


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name