UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029116 |
|---|---|
| Receipt number | R000033300 |
| Scientific Title | Study on the effect of cataract surgery on the visual acuity, spherical equivalent, intraocular pressure after trabeculectomy. |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2017/09/12 21:50:47 |
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Basic information
Public title
Study on the effect of cataract surgery on the visual acuity, spherical equivalent, intraocular pressure after trabeculectomy.
Acronym
Study on the effect of cataract surgery on the visual acuity, spherical equivalent, intraocular pressure after trabeculectomy.
Scientific Title
Study on the effect of cataract surgery on the visual acuity, spherical equivalent, intraocular pressure after trabeculectomy.
Scientific Title:Acronym
Study on the effect of cataract surgery on the visual acuity, spherical equivalent, intraocular pressure after trabeculectomy.
Region
| Japan |
Condition
Condition
primary open angle glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of cataract surgery on visual acuity, spherical equivalent and intraocular pressure on the eye after trabeculectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual acuity
spherical equivalent
intraocular pressure
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
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention for spherical equivalent examination.
Five interventions about 1 week, about 1 month, about 3 months, about 6 months, about 1 year later.
Interventions/Control_2
Intervention for eye axis length examination.
Five interventions about 1 week, about 1 month, about 3 months, about 6 months, about 1 year later.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
primary open angle glaucoma
after trabeculectomy
no eye surgery(control)
the need for surgery
surgery noly PEA+IOL
Key exclusion criteria
other than primary open angle glaucoma
In the study group, patients with ophthalmologic surgical history other than trabeculectomy
patients with ophthalmologic surgery history in the control group
patients with other eye disease
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | RYU IIKAWA |
Organization
Niigata university
Division name
Ophthalmology
Zip code
Address
Niigata-city Chuo-ku Asahimachidori 1-757
TEL
025-223-6161
ryu.iikawa@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | RYU IIKAWA |
Organization
Niigata university
Division name
Ophthalmology
Zip code
Address
Niigata-city Chuo-ku Asahimachidori 1-757
TEL
025-223-6161
Homepage URL
ryu.iikawa@gmailcom
Sponsor or person
Institute
Niigata university
Institute
Department
Personal name
Funding Source
Organization
Niigata university
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
| 2017 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 08 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 12 | Day |
Last modified on
| 2017 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033300
