UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000617 |
|---|---|
| Receipt number | R000000749 |
| Scientific Title | The study for improvement of visual function and quality of vision after ophthalmic surgeries |
| Date of disclosure of the study information | 2007/02/26 |
| Last modified on | 2018/07/30 10:22:46 |
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Basic information
Public title
The study for improvement of visual function and quality of vision after ophthalmic surgeries
Acronym
The Study for improvement of visual function and quality of vision after ophthalmic surgeries
Scientific Title
The study for improvement of visual function and quality of vision after ophthalmic surgeries
Scientific Title:Acronym
The Study for improvement of visual function and quality of vision after ophthalmic surgeries
Region
| Japan |
Condition
Condition
ocular diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test improvement of visual functions, quality of life (QOL), and quality of vision (QOV) after intraocular and extraocular surgeries.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pre and postoperative assessment for visual functions including measurements of visual acuity, refractive error, corneal curvature, corneal thickness, axial length, visual field, and macular pigment density; fundus evaluations by using fundus photography and optical coherence tomography. Pre, 3 months, and 12 months postoperative assessment for QOL and QOV by using SF-36 and NEI VFQ-25, respectively, questionaires.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
cataract surgery
1.2007-12.2011
Interventions/Control_2
glaucoma surgery
1.2007-12.2011
Interventions/Control_3
vitreo-retinal surgery
1.2007-12.2011
Interventions/Control_4
extraocular surgery
1.2007-12.2011
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
Patients who will receive intra- and extra-ocular surgeries.
Key exclusion criteria
Patients having a history of former ocular surgeries.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Tanito |
Organization
Shimane University Faculty of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Enya 89-1, Izumo, Shimane, 693-8501
TEL
0853-20-2284
tanito0oph@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Tanito |
Organization
Shimane University Faculty of Medicine
Division name
Department of Ophthalmology
Zip code
Address
89-1 Enya, Izumo, 693-8501, Japan
TEL
0853-20-2284
Homepage URL
tanito0oph@umin.ac.jp
Sponsor or person
Institute
Departmet of Ophthalmology, Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2007 | Year | 02 | Month | 26 | 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
| 2006 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 02 | Month | 24 | Day |
Last modified on
| 2018 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000749
