UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009114
Receipt number R000010689
Scientific Title Examination of prognostic factor by OCT in patient with epiretinal membrane
Date of disclosure of the study information 2012/10/15
Last modified on 2012/10/15 16:14:03

* 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

Examination of prognostic factor by OCT in patient with epiretinal membrane

Acronym

Examination of prognostic factor by OCT in patient with epiretinal membrane

Scientific Title

Examination of prognostic factor by OCT in patient with epiretinal membrane

Scientific Title:Acronym

Examination of prognostic factor by OCT in patient with epiretinal membrane

Region

Japan


Condition

Condition

epiretinal membrane

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the prognostic factors for vitrectomy in patients with epiretinal
membrane (ERM) using spectral-domain optical coherence tomography (SD-OCT).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The prognostic factors influencing postoperative BCVA.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients with epiretinal membrane

Key exclusion criteria

eyes with secondary ERM caused by conditions such as diabetic retinopathy, venous
occlusion, retinal detachment, uveitis, trauma, or other ocular pathologies that could have
interfered with the functional results, especially patients with severe cataract of more than
grade 3 nuclear sclerosis and/or cortical opacity, were excluded.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name shiono akira

Organization

st marianna university school of medicine

Division name

depertment of ophthalmology

Zip code


Address

sugao miyamae ward kawasaki city 2-16-1

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

st marianna university school of medicine

Division name

depertment of ophthalmology

Zip code


Address


TEL

044-977-8111

Homepage URL


Email



Sponsor or person

Institute

department of ophthalmology

Institute

Department

Personal name



Funding Source

Organization

department of ophthalmology

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

2012 Year 10 Month 15 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

2009 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 04 Month 08 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Ophthalmic evaluations included best-corrected visual acuity (BCVA) and OCT parameters
before and 1, 3, and 6 months after surgery


Management information

Registered date

2012 Year 10 Month 15 Day

Last modified on

2012 Year 10 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010689


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name