UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007564
Receipt number R000008936
Scientific Title Inverted internal limiting membrane flap technique for macular hole retinal detachment.
Date of disclosure of the study information 2012/04/02
Last modified on 2017/04/04 16:24:14

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Basic information

Public title

Inverted internal limiting membrane flap technique for macular hole retinal detachment.

Acronym

Inverted internal limiting membrane flap technique for macular hole retinal detachment.

Scientific Title

Inverted internal limiting membrane flap technique for macular hole retinal detachment.

Scientific Title:Acronym

Inverted internal limiting membrane flap technique for macular hole retinal detachment.

Region

Japan


Condition

Condition

Macular hole retinal detachment

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 macular hole retinal detachment.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Initial reattachment rate

Key secondary outcomes

Best corrected visual acuity, closeure rate of macular hole


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 1 week after surgery 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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1) 20< years of age <80
2) Macular hole retinal detachment with axial length >26 mm
3) No prior vitrectomy
4) Be able to keep prone position and fill out a questionnaire
5) Written imformed consent

Key exclusion criteria

1) Prolifelative vitreoretinopathy
2) Judged as inappropriate by doctor

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shin Yamane

Organization

Yokohama City University Medical Center

Division name

Ophthalmology

Zip code


Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Email

shinyama@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shin Yamane

Organization

Yokohama City University Medical Center

Division name

Ophthalmology

Zip code


Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Homepage URL


Email

shinyama@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University Medical Center

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

横浜市立大学附属市民総合医療センター(神奈川県)


Other administrative information

Date of disclosure of the study information

2012 Year 04 Month 02 Day


Related information

URL releasing protocol


Publication of results

Published


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 03 Month 23 Day

Date of IRB


Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date

2015 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 03 Month 23 Day

Last modified on

2017 Year 04 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008936


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name