UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019316 |
|---|---|
| Receipt number | R000022335 |
| Scientific Title | Visual functions following various vitreoretinal disorders |
| Date of disclosure of the study information | 2015/10/13 |
| Last modified on | 2015/10/19 14:13:58 |
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Basic information
Public title
Visual functions following various vitreoretinal disorders
Acronym
Visual functions for various vitreoretinal disorders
Scientific Title
Visual functions following various vitreoretinal disorders
Scientific Title:Acronym
Visual functions for various vitreoretinal disorders
Region
| Japan |
Condition
Condition
Macular hole, Epiretinal membrane, Diabetic retinopathy, Cystoid macular edema, Retinal detachment, Asteroid hyalosis, Vitreous opacity, Retinal vascular diseases and retinal nerve diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate objective and subjective visual functions following various vitreoretinal disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective visual functions (Visual acuity, practical visual acuity, contrast sensitivity, metamorphopsia, aniseikonia, stereopsis, scatter, color vision, visual field, retinal sensitivity)
Objective visual functions (Wavefront aberration, corneal structure, retinal structure, erectroretinogram, opacity of lens)
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Macular hole, Epiretinal membrane, Diabetic retinopathy, Cystoid macular edema, Retinal detachment, Asteroid hyalosis, Vitreous opacity with after cataract, Retinal vascular diseases, Retinal nerve diseases.
(2) No history of severe ocular diseases
(3) Provide a signed informed consent form after receiving a explanation about this study
Key exclusion criteria
(1) History of severe ocular diseases in the study eye
(2) Subjects who judged by a investigator to be inappropriate for the study
Target sample size
430
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumiki Okamoto |
Organization
University of Tsukuba
Division name
Department of Ophthalmology, Faculty of Medicine
Zip code
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575 Japan
TEL
029-853-3148
fumiki-o@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumiki Okamoto |
Organization
University of Tsukuba
Division name
Department of Ophthalmology, Faculty of Medicine
Zip code
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575 Japan
TEL
029-853-3148
Homepage URL
fumiki-o@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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
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
| 2015 | Year | 10 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Start of subject enrolment: 10/13, 2016
End of subject enrolment: 3/31, 2018
Examination of Visual functions
A. Visual acuity (at pretoreatment, 1day, 1,2week, 1,2,3,4,5,6,7,8,9,10,11,12month)
B. Functional visual acuity (at pretoreatment, 1,2,3,4,5,6,7,8,9,10,11,12month)
C. Contrast sensitivity (at pretoreatment, 1,2,3,4,5,6,7,8,9,10,11,12month)
D. Metamorphopsia (at pretoreatment, 1,2,3,4,5,6,7,8,9,10,11,12month)
E. Anieikonia (at pretoreatment, 1,3,6,12month)
F. Stereopsis (at pretoreatment, 1,3,6,12month)
G. Scatter (at pretoreatment, 1day, 1,2week, 1,2,3,4,5,6,7,8,9,10,11,12month)
H. Color vision (at pretoreatment, 1,3,6,12month)
I. Visual field (at pretoreatment, 1,3,6,12month)
J. Retinal sensitivity (at pretoreatment, 1day, 1,2week, 1,2,3,4,5,6,7,8,9,10,11,12month)
K. Higherorder abberation (at pretoreatment, 1,3,6,12month)
L. Corneal topography (at pretoreatment, 1,3,6,12month)
M. Retinal microstructure (at pretoreatment, 1day, 1,2week, 1,2,3,4,5,6,7,8,9,10,11,12month)
N. Electroretinography (at pretoreatment, 1,3,6,12month)
O. Lens opacity (at pretoreatment, 1,3,6,12month)
Management information
Registered date
| 2015 | Year | 10 | Month | 12 | Day |
Last modified on
| 2015 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022335
