UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044584
Receipt number R000050923
Scientific Title Study on Ocular changes after strabismus srugery
Date of disclosure of the study information 2021/06/18
Last modified on 2022/07/26 08:04:59

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Basic information

Public title

Study on eye changes after eye muscle surgery

Acronym

Eye and strabismus surgery

Scientific Title

Study on Ocular changes after strabismus srugery

Scientific Title:Acronym

Ocular change and strabismus surgery

Region

Japan


Condition

Condition

strabismus

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate structual and functional change after strabismus surgery

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Change of intraocular pressure

Key secondary outcomes

Change of eye position


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

muscle transposition

Interventions/Control_2

recess resect procedure

Interventions/Control_3

muscle transpoisition and medial rectus recession

Interventions/Control_4

no treatment

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

available of multiple IOP measurements

Key exclusion criteria

unable of multiple IOP measurements

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Miho
Middle name
Last name Sato

Organization

Hamamatsu university school of medicine

Division name

ophthalmology

Zip code

431-3192

Address

Handa-yama, Higashi-Ku, Hamamatsu

TEL

0534352256

Email

mihosato@hama-med.ac.jp


Public contact

Name of contact person

1st name Miho
Middle name
Last name Sato

Organization

Hamamatsu university school of medicine

Division name

ophthalmology

Zip code

431-3192

Address

Handa-yama, Higashi-Ku, Hamamatsu

TEL

0534352256

Homepage URL


Email

mihosato@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu university school of medicine

Institute

Department

Personal name



Funding Source

Organization

Kakenhi

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hamamatsu university school of medicine

Address

Handa-yama, Higashi-Ku, Hamamatsu

Tel

0534352256

Email

mihosato@hama-med.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

浜松医科大学(静岡県)


Other administrative information

Date of disclosure of the study information

2021 Year 06 Month 18 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

Enrolling by invitation

Date of protocol fixation

2021 Year 04 Month 01 Day

Date of IRB

2021 Year 04 Month 23 Day

Anticipated trial start date

2021 Year 06 Month 01 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry

2023 Year 12 Month 31 Day

Date trial data considered complete

2023 Year 12 Month 31 Day

Date analysis concluded

2024 Year 07 Month 31 Day


Other

Other related information



Management information

Registered date

2021 Year 06 Month 17 Day

Last modified on

2022 Year 07 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050923


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name