UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006993
Receipt number R000008251
Scientific Title a clinical case controled trial for the intraocular tamponade in the vitrectomy for rhegmatogenous retinal detachment(RRD).
Date of disclosure of the study information 2012/01/01
Last modified on 2011/12/30 20:11:53

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Basic information

Public title

a clinical case controled trial for the intraocular tamponade in the vitrectomy for rhegmatogenous retinal detachment(RRD).

Acronym

RRD tamponade study

Scientific Title

a clinical case controled trial for the intraocular tamponade in the vitrectomy for rhegmatogenous retinal detachment(RRD).

Scientific Title:Acronym

RRD tamponade study

Region

Japan


Condition

Condition

Rhegmatogenous retinal detachment

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Sulfer hexafluoride(SF6) is commonly used for the treatment of the rhegmatogenous retinal detachment(RRD).
In order to make face down position of post operative 7-10 days. After vitrectomy using other kinds of taamponade materials. We hypothesize to use room air instead of SF6 would be able to make face down term shorter than that of SF6.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

we try to compare the improvement of the retio of reattachment and BCVA after vitrectomy at the point of 1.3.6.12 months postoperatively.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

We replace vitreous with air at the end of surgery. The air tamponade will disappear applex 7 days.

Interventions/Control_2

We replace vitreous with SF6 at the end of surgery. The air tamponade will disappear applex 14 days.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

The RRD patients who consulted this hospital and meet following criterion.
.A clinical record at the time of study entry contains no definiency for essential points.
.20 yearsold or older.
.The affected eye caan be evaluated of the retinal tear at the upper of retina and the RRD is not old RRD.
.The affected eye shuld have no other clinically significant abnormality which may cause loss of vision.
.The affected eye does noy have the record of votreous surgery.
.The eye length oh affected eye is not 26mm or over 26mm.

Key exclusion criteria

.When the patient does not hope for entry.
.In the case when there is a unsuspected worsening of the disease or advance event which the patient should exist this study.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshimitsu Ishiguro

Organization

Kansai medical university

Division name

Hirakata hospital

Zip code


Address

2-3-1,shinmachi,hirakata city,Osaka

TEL

0728040101

Email



Public contact

Name of contact person

1st name
Middle name
Last name Toshimitsu Ishiguro

Organization

Kansai medical university

Division name

Hirakata hospital

Zip code


Address

2-3-1,shinmachi,hirakata city,Osaka

TEL

0728040101

Homepage URL


Email



Sponsor or person

Institute

Department of ophthalmology,Kansai medical university

Institute

Department

Personal name



Funding Source

Organization

none

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


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

2012 Year 01 Month 01 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

Preinitiation

Date of protocol fixation

2011 Year 10 Month 20 Day

Date of IRB


Anticipated trial start date

2012 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 12 Month 30 Day

Last modified on

2011 Year 12 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008251


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name