UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033229 |
|---|---|
| Receipt number | R000037883 |
| Scientific Title | A prospective observational study of Bowman's layer transplantation for advanced keratoconus |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2023/07/09 15:48:02 |
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Basic information
Public title
A prospective observational study of Bowman's layer transplantation for advanced keratoconus
Acronym
Bowman's layer transplantation for advanced keratoconus
Scientific Title
A prospective observational study of Bowman's layer transplantation for advanced keratoconus
Scientific Title:Acronym
Bowman's layer transplantation for advanced keratoconus
Region
| Japan |
Condition
Condition
keratoconus, keratoectasia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This purpose of study is evaluation of the safety and efficacy of Bowman's layer transplantation (BLT). Examinations are scheduled one day, within a week, one week, 1 month, 3 months, 6 months, and 1 year after surgery, that include the topographic change, specular microsopy (endothelial cell density; ECD),and pachimetry(corneal thinckness) as well as standard ophthalmic examinations. After that, the follow-up will be scheduled every year for the purpose of evaluating the safety and efficacy of BLT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
best spectacle-corrected visual acuity (BSCVA), and refraction (K-value) at 1 month, 3 months, 6 months, and 1 year postoperatively.
Key secondary outcomes
best spectacle-corrected visual acuity (BSCVA), best contact lens-corrected visual acuity (BCLVA), AS-OCT-based corneal tomography measurements, endothelial cell density, refraction (K-value), and intraoperative, postoperative complications anterior and posterior HOAs, contact lens intolerance, and evaluation of the corneal structure using confocal microscopy at 1 month, 3 months, 6 months, and 1 year postoperatively.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients of advanced keratoconus or keratoectasia that are classified as stage 3 or 4 of Amsler-Krumeich classification, and are consistent with the conditions as shown belows;
Average K-value is under 50D, and K-max is over 60D.
The corneal thickness of apex is thinner than 400 um.
Pathiens with contact lens intolerance.
Key exclusion criteria
Age is under 20 years old.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | TAKAHIKO |
| Middle name | |
| Last name | HAYASHI |
Organization
Yokohama Minami Kyosai Hospital
Division name
Ophthalmology
Zip code
2360037
Address
1-21-1, Mutsuura-HigashiKanazawa-ku, Yokohama City, Kanagawa
TEL
+81457872101
htakahiko-aikou@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takahiko |
| Middle name | |
| Last name | Hayashi |
Organization
Yokohama Minami Kyosai Hospital
Division name
Cornea Center
Zip code
2360037
Address
Kanazawa-ku
TEL
+817038502167
Homepage URL
takamed@gmail.com
Sponsor or person
Institute
Department of Ophthalmology, Yokohama Minami Kyosai Hospital
Institute
Department
Personal name
Funding Source
Organization
No funding
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
Yokohama Minami Kyosai Hospital
Address
1-21-1, Mutsuura-Higashi Kanazawa-ku, Yokohama
Tel
+81457872101
htakahiko-aikou@umin.ac.jp
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
| 2018 | Year | 08 | Month | 01 | 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
| Delay expected |
Results Delay Reason
Lack of a number of candidates
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
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
No result.
Management information
Registered date
| 2018 | Year | 07 | Month | 02 | Day |
Last modified on
| 2023 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037883
