UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051282 |
|---|---|
| Receipt number | R000058488 |
| Scientific Title | Research on clinical outcomes after implantation of artificial cornea. |
| Date of disclosure of the study information | 2023/06/07 |
| Last modified on | 2023/07/09 15:43:48 |
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Basic information
Public title
Research on efficacy and safety of the artificial cornea for bullous keratopathy
Acronym
Research on clinical outcomes after implantation of artificial cornea.
Scientific Title
Research on clinical outcomes after implantation of artificial cornea.
Scientific Title:Acronym
Research on clinical outcomes after implantation of artificial cornea.
Region
| Japan |
Condition
Condition
Bullous keratopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety after transplanting the artificial corneal endothelium (Endart).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective symptoms, visual acuity, intraocular pressure, anterior,and posterior segment optical coherence tomography(OCT),confocal
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Implantation of artificial corneal endothelium
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with corneal endothelial dysfunction who are resistant to repeated keratoplasty.
Key exclusion criteria
Patients with corneal endothelial dysfunction who has never had keratoplasty.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takahiko |
| Middle name | |
| Last name | Hayashi |
Organization
Kikuna Yuda Eye Clinic
Division name
Ophthalmology
Zip code
222-0011
Address
4-3-11 Kikuna, Kouhokuku, Yokohama, Kanagawaken 222-0011, Japan
TEL
+81454353755
takamed@gmail.com
Public contact
Name of contact person
| 1st name | Takahiko |
| Middle name | |
| Last name | Hayashi |
Organization
Kikuna Yuda Eye Clinic
Division name
Ophthalmology
Zip code
222-0011
Address
4-3-11 Kikuna, Kouhokuku, Yokohama, Kanagawaken 222-0011, Japan
TEL
+81454353755
Homepage URL
takamed@gmail.com
Sponsor or person
Institute
Kikuna Yuda Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Kikuna Yuda Eye Clinic
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
Kikuna Yuda Eye Clinic
Address
4-3-11 Kikuna, Kouhokuku, Yokohama, Kanagawaken 222-0011, Japan
Tel
045-435-3755/+81454353755
takamed@gmail.com
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
きくな湯田眼科
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 07 | 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
0
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
Terminated
Date of protocol fixation
| 2023 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 07 | Day |
Last modified on
| 2023 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058488
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
