UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012558
Receipt number R000014693
Scientific Title Ultra Wide-Field Fundus Autofluorescence Imaging to Evaluate Retinal Function in Patients with Retinitis Pigmentosa
Date of disclosure of the study information 2013/12/12
Last modified on 2014/01/04 08:26:11

* 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

Ultra Wide-Field Fundus Autofluorescence Imaging to Evaluate Retinal Function in Patients with Retinitis Pigmentosa

Acronym

Ultra Wide-Field Fundus Autofluorescence in Retinitis Pigmentosa

Scientific Title

Ultra Wide-Field Fundus Autofluorescence Imaging to Evaluate Retinal Function in Patients with Retinitis Pigmentosa

Scientific Title:Acronym

Ultra Wide-Field Fundus Autofluorescence in Retinitis Pigmentosa

Region

Japan


Condition

Condition

Retinitis Pigmentosa

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To study the correlation between the visual fields (VF) and ultra wide-field fundus autofluorescence (wfFAF) in patients with retinitis pigmentosa (RP).

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The relationship between the areas of hypoautofluorescence on the wfFAF images and scotoma on GP were evaluated.

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 a clinical diagnosis of RP

Key exclusion criteria

Eyes were excluded if any factors impaired the resolution of FAF and the reliability of the GP results, such as dense cataracts, nystagmus, and poor fixation due to central visual loss.

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsutomu Yasukawa

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Ophthalmology and Visual Science

Zip code


Address

Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601, JAPAN

TEL

+81-52-8538251

Email

yasukawa@med.nagoya-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tsutomu Yasukawa

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Ophthalmology and Visual Science

Zip code


Address

Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601, JAPAN

TEL

+81-52-8538251

Homepage URL


Email

yasukawa@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

Nagoya City University Graduate School of Medical Sciences

Organization

Division

Category of Funding Organization

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

2013 Year 12 Month 12 Day


Related information

URL releasing protocol


Publication of results

Partially 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

2011 Year 03 Month 31 Day

Date of IRB


Anticipated trial start date

2011 Year 04 Month 01 Day

Last follow-up date

2012 Year 12 Month 31 Day

Date of closure to data entry

2013 Year 12 Month 12 Day

Date trial data considered complete

2013 Year 12 Month 12 Day

Date analysis concluded

2013 Year 12 Month 12 Day


Other

Other related information

The areas of hypoautofluorescence on the wfFAF images were correlated significantly with the areas of the VF defects on GP. The areas of geographic hypoautofluorescent with or without hyperautofluorescent bands reflected the VF defects, while nummular, granular, or mottled hypoautofluorescence without VF defects was seen in seven eyes.


Management information

Registered date

2013 Year 12 Month 12 Day

Last modified on

2014 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014693


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name