UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022310 |
|---|---|
| Receipt number | R000025704 |
| Scientific Title | A randomized parallel-group trial for influence of upper and temporal transconjunctival sclerocorneal incision on marginal reflex distance after cataract surgery |
| Date of disclosure of the study information | 2016/06/09 |
| Last modified on | 2016/06/09 08:52:45 |
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Basic information
Public title
A randomized parallel-group trial for influence of upper and temporal transconjunctival sclerocorneal incision on marginal reflex distance after cataract surgery
Acronym
Influence of position of transconjunctival sclerocorneal incision in marginal reflex distance after cataract surgery
Scientific Title
A randomized parallel-group trial for influence of upper and temporal transconjunctival sclerocorneal incision on marginal reflex distance after cataract surgery
Scientific Title:Acronym
Influence of position of transconjunctival sclerocorneal incision in marginal reflex distance after cataract surgery
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the marginal reflex distance 1 (MRD1) preoperatively and postoperatively between the two different incision types during cataract srugery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Marginal reflex distance 1 (MRD1) preoperatively and at three months postoperatively
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Group for an upper 2.4-mm transconjunctival sclerocorneal incision during cataract operation
Interventions/Control_2
Group for a temporal 2.4-mm transconjunctival sclerocorneal incision during cataract operation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with cataract
Key exclusion criteria
Patients with a history of thyroid eye disease, proptosis, enophthalmos, or previous lid or ocular surgery
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Zako |
Organization
Aichi Medical University
Division name
Department of Ophthalmology
Zip code
Address
1-1 Karimata, Yazako, Nagakute, Aichi
TEL
0561623311
Mzako@aol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Zako |
Organization
Aichi Medical University
Division name
Department of Ophthalmology
Zip code
Address
1-1 Karimata, Yazako, Nagakute, Aichi
TEL
0561623311
Homepage URL
http://www.aichi-med-u.ac.jp/su06/su0611/su061100/__icsFiles/afieldfile/2013/11/01/rin_H25-06.pdf
Mzako@aol.com
Sponsor or person
Institute
Aichi Medical University
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
愛知医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 09 | 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
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 06 | Day |
Date of closure to data entry
| 2015 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 14 | Day |
Last modified on
| 2016 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025704
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
