UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023598
Receipt number R000027168
Scientific Title Impact of postoperative positioning on the outcome of pars plana vitrectomy with gas tamponade for primary rhegmatogenous retinal detachment: Comparison between supine and prone positioning
Date of disclosure of the study information 2016/09/01
Last modified on 2017/11/08 10:30:11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Impact of postoperative positioning on the outcome of pars plana vitrectomy with gas tamponade for primary rhegmatogenous retinal detachment: Comparison between supine and prone positioning

Acronym

Supine vs prone positioning after PPV for RRD

Scientific Title

Impact of postoperative positioning on the outcome of pars plana vitrectomy with gas tamponade for primary rhegmatogenous retinal detachment: Comparison between supine and prone positioning

Scientific Title:Acronym

Supine vs prone positioning after PPV for RRD

Region

Japan


Condition

Condition

rhegmatogenous retinal detachment

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the postoperative anatomic success rates and the frequency of complications between prone or supine postoperative positioning after vitrectomy for rhegmatogenous retinal detachment (RRD).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

retinal reattachment rate

Key secondary outcomes

visual acuity,intraocular pressure,surgically induced astigmatism,flare,postoperative complication


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Group 1: patients who were instructed to keep strict postoperative prone and lateral positioning

Interventions/Control_2

Group 2: patients who were instructed to keep strict postoperative supine and lateral positioning

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

Patients who underwent vitreous surgery for rhegmatogenous retinal detachment

Key exclusion criteria

1)Patients who could not perform the postoperative examinations
2)Re-surgery case
3)Cases of non-regmatogenous retinal detachment

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisanori Imai

Organization

Kobe University Hospital

Division name

Ophthalmology

Zip code


Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, 650-0017, Japan

TEL

0783825111

Email

hisimai@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hisanori Imai

Organization

Kobe University Hospital

Division name

Ophthalmology

Zip code


Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, 650-0017, Japan

TEL

0783825111

Homepage URL


Email

hisimai@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University Hospital

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

2016 Year 09 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

Terminated

Date of protocol fixation

2016 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 09 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

2016 Year 08 Month 12 Day

Last modified on

2017 Year 11 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027168


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name