UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057925 |
|---|---|
| Receipt number | R000063856 |
| Scientific Title | A prospective observational study of corneal stromal transplantation corneal for advanced keratoconus |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/05/31 12:35:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A prospective observational study of corneal stromal transplantation for advanced keratoconus
Acronym
a study of corneal stromal transplantation for advanced keratoconus
Scientific Title
A prospective observational study of corneal stromal transplantation corneal for advanced keratoconus
Scientific Title:Acronym
A study of corneal stromal transplantation corneal 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 corneal stromal transplant. 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 corneal stromal transplant.
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. Intraoperative and postoperative complications.
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
| 14 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 14 years or older of advanced keratoconus or keratoectasia are classified as stage 3 or 4 of Amsler-Krumeich classification
Key exclusion criteria
Age is under 14 years old.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | TAKAHIKO |
| Middle name | |
| Last name | HAYASHI |
Organization
Nihon University Hospital
Division name
Opthalmology
Zip code
1738610
Address
30-1 Oyaguchi-kamicho, Itabashiku
TEL
03-3972-8111
htakahiko-aikou@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takahiko |
| Middle name | |
| Last name | Hayashi |
Organization
Nihon University Hospital
Division name
Opthalmology
Zip code
1738610
Address
30-1 Oyaguchi-kamicho, Itabashiku
TEL
03-3972-8111
Homepage URL
htakahiko-aikou@umin.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Nihon University Hospital
Institute
Department
Personal name
takahiko hayashi
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
Nihon University Hospital
Address
30-1 Oyaguchi-kamicho, Itabashiku
Tel
0339728111
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
| 2025 | Year | 06 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special note
Management information
Registered date
| 2025 | Year | 05 | Month | 20 | Day |
Last modified on
| 2025 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063856
