UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024550 |
|---|---|
| Receipt number | R000027744 |
| Scientific Title | Comparison of anterior staining fluids in cataract surgery |
| Date of disclosure of the study information | 2016/10/24 |
| Last modified on | 2016/10/24 20:30:16 |
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Basic information
Public title
Comparison of anterior staining fluids in cataract surgery
Acronym
Effect on the corneal endothelium of the staining fluids
Scientific Title
Comparison of anterior staining fluids in cataract surgery
Scientific Title:Acronym
Effect on the corneal endothelium of the staining fluids
Region
| Japan |
Condition
Condition
cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate potential toxicity of two staining fluids of trypan blue (hereinafter, TB) and Brilliant Blue G (hereinafter, BBG) to corneal endothelial cells. Both fluids are used for anterior capsule staining intraoperative time
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The completion rate of successive continuous circular capsulorrhexis (hereinafter,CCC) during cataract surgery along with the corrected vision (logMAR), reduced corneal endothelial cell count (ECD), and change in central corneal thickness (CCT) prior to and following cataract surgery were compared.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
BSS 1.0 ml was injected into the anterior chamber for the CT group.
Interventions/Control_2
BBG 1.0 ml was injected injected into the anterior chamber for the BBG group.
The concentration of BBG was 0.1%
Interventions/Control_3
TB 1.0 ml was injected injected into the anterior chamber for the TB group.
The concentration of TB was 0.1%
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
People with cataract
Key exclusion criteria
Patients with a history of internal eye surgery such as vitreous surgery, etc., or a history of corneal diseases such as corneal endothelial inflammation, interstitial keratitis, etc., that included the fellow eye were excluded. Moreover, cases with a corneal endothelial count of less than 2000/mm2 during preoperative evaluation, cases of mature cataract and cases in which extracapsular cataract extraction/intracapsular cataract extraction were carried out during surgery. Further, cases in which the patient discontinued consultation during the 6 months of the postoperative follow-up period were also excluded.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takamitsu Nagashima |
Organization
Department of Ophthalmology Saitama Medical University
Division name
Ophthalmology
Zip code
Address
38 Morohongo Moroyama-machi, Iruma, Saitama 350-0495, Japan
TEL
+81-49-276-1125
howdoyoulikechosan1027@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takamitsu Nagashima |
Organization
Department of Ophthalmology Saitama Medical University
Division name
Ophthalmology
Zip code
Address
38 Morohongo Moroyama-machi, Iruma, Saitama 350-0495, Japan
TEL
+81-49-276-1125
Homepage URL
howdoyoulikechosan1027@gmail.com
Sponsor or person
Institute
Department of Ophthalmology,Yokohama Minami Kyousai Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2016 | Year | 10 | Month | 24 | 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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 24 | Day |
Last modified on
| 2016 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027744
