UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005828
Receipt number R000006879
Scientific Title Comparison of visual outcome among 3 adjuvants for ILM staining after long-term follow-up for idiopathic macular hole surgeries
Date of disclosure of the study information 2011/07/01
Last modified on 2015/06/23 16:28:15

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Basic information

Public title

Comparison of visual outcome among 3 adjuvants for ILM staining after long-term follow-up for idiopathic macular hole surgeries

Acronym

Comparison of visual outcome among 3 adjuvants for ILM staining after long-term follow-up for idiopathic macular hole surgeries

Scientific Title

Comparison of visual outcome among 3 adjuvants for ILM staining after long-term follow-up for idiopathic macular hole surgeries

Scientific Title:Acronym

Comparison of visual outcome among 3 adjuvants for ILM staining after long-term follow-up for idiopathic macular hole surgeries

Region

Japan


Condition

Condition

idiopathic macular hole

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

It is necessary to develop new adjuvant for internalnner limiting membrane peeling of macular hole surgery to avoid retinal damage. We compared the results using newly developed Brilliant Blue G (BBG) with conventional Indocyanine Green (ICG) or Triamcinolone Acetonide (TA).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

postoperative visual acuity
initial closure rates
complications

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

BBG

Interventions/Control_2

ICG

Interventions/Control_3

TA

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent vitreous surgery for idiopathic macular hole at the Yamagata University Hospital and were followed for 3 months or more after surgery.

Key exclusion criteria

MH of stage1

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noriko Mochizuki

Organization

Yamagata University Faculty of Medicine

Division name

Department of Ophthalmology and Visual Science

Zip code


Address

2-2-2 Iida-nishi yamagata

TEL

0236285374

Email

m.noriko@med.id.yamagata-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noriko Mochizuki

Organization

Yamagata University Faculty of Medicine

Division name

Department of Ophthalmology and Visual Science

Zip code


Address

2-2-2 Iida-nishi yamagata

TEL

0236285374

Homepage URL


Email

m.noriko@med.id.yamagata-u.ac.jp


Sponsor or person

Institute

Department of Ophthalmology and Visual Science,Yamagata University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2011 Year 07 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/25201225

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

2007 Year 01 Month 10 Day

Date of IRB


Anticipated trial start date

2007 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 06 Month 22 Day

Last modified on

2015 Year 06 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006879