UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040323
Receipt number R000046011
Scientific Title Evaluation of Cause and Prognosis in Eyes Requiring Implantable Collamer Lens Extraction.
Date of disclosure of the study information 2020/10/15
Last modified on 2020/11/06 09:08:10

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Basic information

Public title

Evaluation of Cause and Prognosis in Eyes Requiring Implantable Collamer Lens Extraction.

Acronym

Cause and Prognosis in Eyes Requiring Implantable Collamer Lens Extraction.

Scientific Title

Evaluation of Cause and Prognosis in Eyes Requiring Implantable Collamer Lens Extraction.

Scientific Title:Acronym

Cause and Prognosis in Eyes Requiring Implantable Collamer Lens Extraction.

Region

Japan


Condition

Condition

myopia

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of Implantable Collamer Lens Extraction.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Postoperative visual acuity, refraction, endothelium, satisfaction

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

28 years-old <=

Age-upper limit

59 years-old >=

Gender

Male and Female

Key inclusion criteria

A case of ICL extraction surgery at Kitasato University Hospital

Key exclusion criteria

nothing

Target sample size

8


Research contact person

Name of lead principal investigator

1st name Syoji
Middle name
Last name Nobuyuki

Organization

Kitasato Univ Hospital

Division name

opthalmology

Zip code

252-0374

Address

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

TEL

0427788464

Email

m09088w@st.kitasato-u.ac.jp


Public contact

Name of contact person

1st name Hideki
Middle name
Last name Hayakawa

Organization

Kitasato Univ Hospital

Division name

opthalmology

Zip code

252-0374

Address

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

TEL

0427788464

Homepage URL


Email

m09088w@st.kitasato-u.ac.jp


Sponsor or person

Institute

Kitasato Univ Hospital

Institute

Department

Personal name



Funding Source

Organization

nothing

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 Univ Hospital

Address

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

Tel

0427788464

Email

m09088w@st.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

2020 Year 10 Month 15 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

7

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

Main results already published

Date of protocol fixation

2020 Year 04 Month 20 Day

Date of IRB

2020 Year 08 Month 21 Day

Anticipated trial start date

2020 Year 04 Month 20 Day

Last follow-up date

2020 Year 04 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

retrospective study


Management information

Registered date

2020 Year 05 Month 07 Day

Last modified on

2020 Year 11 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046011


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name