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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022310
Receipt No. 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

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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
Email 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
Email Mzako@aol.com

Sponsor
Institute Aichi Medical University
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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