UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011170 |
|---|---|
| Receipt number | R000013084 |
| Scientific Title | A PROSPECTIVE RANDOMIZED COMPARATIVE STUDY ON THE EFFICACY AND SAFETY OF THREE DIFFERENT SURGICAL PROCEDURES FOR CONJUNCTIVOCHALASIS |
| Date of disclosure of the study information | 2013/07/11 |
| Last modified on | 2017/05/03 22:05:59 |
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Basic information
Public title
A PROSPECTIVE RANDOMIZED COMPARATIVE STUDY ON THE EFFICACY AND SAFETY OF THREE DIFFERENT SURGICAL PROCEDURES FOR CONJUNCTIVOCHALASIS
Acronym
THE EFFICACY AND SAFETY OF THREE DIFFERENT SURGICAL PROCEDURES FOR CONJUNCTIVOCHALASIS
Scientific Title
A PROSPECTIVE RANDOMIZED COMPARATIVE STUDY ON THE EFFICACY AND SAFETY OF THREE DIFFERENT SURGICAL PROCEDURES FOR CONJUNCTIVOCHALASIS
Scientific Title:Acronym
THE EFFICACY AND SAFETY OF THREE DIFFERENT SURGICAL PROCEDURES FOR CONJUNCTIVOCHALASIS
Region
| Japan |
Condition
Condition
conjunctivochalasis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to elucidate the efficacy and safety of three different surgical methods for conjunctivochalasis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
he duration of procedure, complications, frequency of residual conjunctival folds, subjective tolerability of surgery, tear breakup time and subjective symptoms
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
cautery
Interventions/Control_2
tucking
Interventions/Control_3
resection and stitching
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
subjects having aged conjunctivochalasis accompanied with ocular discomfort including foreign body sensation, ocular pain, eyestrain and watery eye.
Key exclusion criteria
subjects who had ocular sergeries
contact lens users
subjects having any ocular surface diseases other than conjunctivochalasis and dry eye
eye drops users
subjects who don't consent in written form
subjects who are ruled unfit to the entry to the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seika Shimazaki-Den |
Organization
Tokyo Dental College Ichikawa General Hospital
Division name
Op
Zip code
Address
5-11-13, Sugano, Ichikawa, Chiba, Japan
TEL
047-322-0151
dens@tdc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mutusmi Ishii |
Organization
Tokyo Dental College Ichikawa General Hospital
Division name
Institutional Review Board
Zip code
Address
5-11-13, Sugano, Ichikawa, Chiba, Japan
TEL
047-322-0151
Homepage URL
mishii@tdc.ac.jp
Sponsor or person
Institute
Toko Dental College Ichikawa General Hospital
Institute
Department
Personal name
Funding Source
Organization
Toko Dental College Ichikawa General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ryogoku Eye Clinic
Name of secondary funder(s)
Ryogoku Eye Clinic
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
東京歯科大学市川総合病院(千葉県）および両国眼科クリニック(東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 11 | 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
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 11 | Day |
Last modified on
| 2017 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013084
| 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 |
