UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005009 |
|---|---|
| Receipt number | R000005954 |
| Scientific Title | evaluation of new truncated contact lens for vitreous surgery |
| Date of disclosure of the study information | 2011/02/02 |
| Last modified on | 2015/08/02 09:16:56 |
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Basic information
Public title
evaluation of new truncated contact lens for vitreous surgery
Acronym
evaluation of new truncated contact lens for vitreous surgery
Scientific Title
evaluation of new truncated contact lens for vitreous surgery
Scientific Title:Acronym
evaluation of new truncated contact lens for vitreous surgery
Region
| Japan |
Condition
Condition
retinal disorders
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and effectiveness of vitreous surgery using new truncated contact lenses.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the safety and effectiveness of vitreous surgery using new truncated contact lenses
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
intraoperative and postoperative complication
surgical time
retinal image
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
diabetic retinopathy, retinal vein occulusion, epiretinal membrane, retinal detachment, macular hole, vitreous hemorrhage
Key exclusion criteria
age < 20 years
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumiki Okamoto |
Organization
Institute of Clinical Medicine, University of Tsukuba
Division name
Department of Ophthalmology
Zip code
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Institute of Clinical Medicine, University of Tsukuba
Division name
Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
fumiki-o@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Institute of Clinical Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Institute of Clinical Medicine, 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
| 2011 | Year | 02 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/22926260
Number of participants that the trial has enrolled
Results
This new truncated contact lens system allows for clear and stereoscopic visualization of the peripheral fundus without scleral depression, so that it could be a useful tool for peripheral vitrectomy in micro-incision vitrectomy.
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 | 01 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 02 | Day |
Last modified on
| 2015 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005954
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
