UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006844 |
|---|---|
| Receipt number | R000008092 |
| Scientific Title | Prospective study of OCT's view,retinal nerve fiber layer, and anterior chamber depth after vitreous surgery for macular hole and epiretinal membrane and anterior chamber depth after cataract surgery. |
| Date of disclosure of the study information | 2011/12/06 |
| Last modified on | 2011/12/06 08:30:14 |
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Basic information
Public title
Prospective study of OCT's view,retinal nerve fiber layer, and anterior chamber depth after vitreous surgery for macular hole and epiretinal membrane and anterior chamber depth after cataract surgery.
Acronym
Prospective study of OCT's view,retinal nerve fiber layer, and anterior chamber depth after vitreous surgery for macular hole and epiretinal membrane.
Scientific Title
Prospective study of OCT's view,retinal nerve fiber layer, and anterior chamber depth after vitreous surgery for macular hole and epiretinal membrane and anterior chamber depth after cataract surgery.
Scientific Title:Acronym
Prospective study of OCT's view,retinal nerve fiber layer, and anterior chamber depth after vitreous surgery for macular hole and epiretinal membrane.
Region
| Japan |
Condition
Condition
macular hole, epiretinal membrane, cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the retinal foveal thickness, retinal nerve fiber layer thickness and anterior chamber depth after surgery for macular hole or epiretinal membrane. And to compare the anterior chamber depth after cataract surgery.
Basic objectives2
Others
Basic objectives -Others
To assess the retinal foveal thickness, retinal nerve fiber layer thickness and anterior chamber depth after surgery for macular hole or epiretinal membrane. And to compare the anterior chamber depth after cataract surgery.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
2 year after surgery
Key secondary outcomes
2 weeks,1,3,6 months,1 year, 2 years
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The first surgery for vitreousmacular hole or epiretinal membrane, no limitation of preoperative visual acuity, no limitation fpr disease period, no limitation for gauge of vitreous surgery, any surgeon, any stage of macular hole
Key exclusion criteria
uveitis glaucoma, pseudoexfoliation syndrome, high myopia, retinitis pigmentosa, history of trauma, history of intraocular surgery, scleral buckling, intraoperative complications (eg, incomplete continuous curvilinear capsulorrhexis; CCC, posterior capsular rupture), posterior capsular CCC, postoperative complications (eg, posterior synechia), silicone oil tamponade, re-operation, post laser iridotomy, YAG laser, and diabetes mellitus.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kitaoka |
Organization
Nagasaki university school of medicine
Division name
Ophthalmology
Zip code
Address
1-7-1 Sakamoto Nagasaki City
TEL
095-819-7345
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mao Kusano |
Organization
Nagasaki university
Division name
Ophthalmology
Zip code
Address
1-7-1 Sakamoto Nagasaki City
TEL
095-819-7345
Homepage URL
Sponsor or person
Institute
Nagasaki university
Institute
Department
Personal name
Funding Source
Organization
Nagasaki university
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 | 12 | Month | 06 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | 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
In vitreous surgery for macular hole or epiretinal membrane, by measuring visual acuity, Optical coherence tomography,visual field, Pentacam, IOL Master is used preoperative, immediately after, as well as 1, 3, 6 and 12 months after surgery.
Management information
Registered date
| 2011 | Year | 12 | Month | 06 | Day |
Last modified on
| 2011 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008092
