UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029302 |
|---|---|
| Receipt number | R000033498 |
| Scientific Title | Comparison of corneal crosslinking and hypertonic NaCl solution as a treatment for bullous keratopathy |
| Date of disclosure of the study information | 2017/09/27 |
| Last modified on | 2018/03/28 07:36:04 |
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Basic information
Public title
Comparison of corneal crosslinking and hypertonic NaCl solution as a treatment for bullous keratopathy
Acronym
Corneal crosslinking and hypertonic NaCl solution for bullous keratopathy
Scientific Title
Comparison of corneal crosslinking and hypertonic NaCl solution as a treatment for bullous keratopathy
Scientific Title:Acronym
Corneal crosslinking and hypertonic NaCl solution for bullous keratopathy
Region
| Japan |
Condition
Condition
Bulllous keratopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of corneal cross linking as a treatment for bullous keratopathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cornea thickness, subjective scores
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Corneal crosslinking
Interventions/Control_2
hypertonic saline instillation
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
# Corneal endothelial dysfunction
# Decreased visual acuity and/or other subjective symptoms due to corneal edema.
Key exclusion criteria
# Other ocular surface diseases
# Corneal infections
# Severe dry eye
# General diseases affecting wound healing on the ocular surface
# In pregnancy or breast feeding
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Shimazaki |
Organization
Tokyo Dental College Ichikawa General Hospital
Division name
Ophthalmology
Zip code
Address
Sugano 5-11-13, Ichikawa, Chiba, Japan
TEL
047-322-0151
jun@eyebank.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko Kato |
Organization
Tokyo Dental College Ichikawa General Hospital
Division name
Ophthalmology
Zip code
Address
Sugano 5-11-13, Ichikawa, Chiba, Japan
TEL
047-322-0151
Homepage URL
naokato@bc.iij4u.or.jp
Sponsor or person
Institute
Tokyo Dental College Ichikawa General Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Dental College Ichikawa General Hospital
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 | 09 | Month | 27 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
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 | 26 | Day |
Last modified on
| 2018 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033498
