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 |
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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
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
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
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
