UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007951
Receipt number R000009355
Scientific Title Inverted internal limiting membrane flap technique for large macular hole
Date of disclosure of the study information 2012/05/15
Last modified on 2021/05/25 08:40:50

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Basic information

Public title

Inverted internal limiting membrane flap technique for large macular hole

Acronym

Inverted internal limiting membrane flap technique for large macular hole

Scientific Title

Inverted internal limiting membrane flap technique for large macular hole

Scientific Title:Acronym

Inverted internal limiting membrane flap technique for large macular hole

Region

Japan


Condition

Condition

large macular hole

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Assess efficacy and safety of inverted internal limiting membrane flap technique in patients with large macular hole.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Closeure rate of macular hole

Key secondary outcomes

Best corrected visual acuity


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Vitrectomy with inverted internal limiting membrane and 20% SF6 gas tamponade. Patients must keep prone position until macular hole closure and avoid supine position until intravitreous gas vanished.

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

(1)20< years of age <85
(2)Be able to keep prone position
(3)Written imformed consent

Key exclusion criteria

highly myopic eye (-6.0 diopter or less)
those with an apparent retinal or choroidal diseases including diabetic retinoparhy, age-related macular degeneration, retinal vein occlusion and others
those with a history of retinal surgery

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Taiji
Middle name
Last name Sakamoto

Organization

Kagoshima University

Division name

Ophthalmology

Zip code

8900075

Address

8-35-1 Sakuragaoka, Kagoshima, Japan

TEL

099-275-5402

Email

tsakamot@m3.kufm.kagoshima-u.ac.jp


Public contact

Name of contact person

1st name Toshifumi
Middle name
Last name Yamashita

Organization

Kagoshima University

Division name

Ophthalmology

Zip code

8900075

Address

8-35-1 Sakuragaoka, Kagoshima, Japan

TEL

099-275-5402

Homepage URL


Email

yyamatos@m.kufm.kagoshima-u.ac.jp


Sponsor or person

Institute

Ophthalmology, Kagoshima University

Institute

Department

Personal name



Funding Source

Organization

A grant from the Ministry of Health, Labor and Welfare, and by a Aid for Scientric Research from the Ministry of Education, Science, and Culture of the Japanese Government

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kagoshima University Hospital

Address

8-35-1 Sakuragaoka, Kagoshima, Japan

Tel

099-275-5402

Email

kufsyomu@kuas.kagoshima-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

鹿児島大学病院、Kagoshima University Hospital


Other administrative information

Date of disclosure of the study information

2012 Year 05 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


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

2012 Year 01 Month 01 Day

Date of IRB

2012 Year 03 Month 04 Day

Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date

2015 Year 11 Month 01 Day

Date of closure to data entry

2015 Year 11 Month 01 Day

Date trial data considered complete

2015 Year 11 Month 01 Day

Date analysis concluded

2015 Year 11 Month 01 Day


Other

Other related information



Management information

Registered date

2012 Year 05 Month 15 Day

Last modified on

2021 Year 05 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009355


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name