UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020256 |
|---|---|
| Receipt number | R000023387 |
| Scientific Title | Effectiveness of Corneal stromal transplantation in corneal stromal thining |
| Date of disclosure of the study information | 2016/01/05 |
| Last modified on | 2016/01/14 12:09:44 |
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Basic information
Public title
Effectiveness of Corneal stromal transplantation in corneal stromal thining
Acronym
Effectiveness of Corneal stromal transplantation
Scientific Title
Effectiveness of Corneal stromal transplantation in corneal stromal thining
Scientific Title:Acronym
Effectiveness of Corneal stromal transplantation
Region
| Japan |
Condition
Condition
Corneal stromal thinning
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate corneal stromal transplantation (donor stroma prepred by femto-seconfd laser) in case with corneal stromal thinning including keratoconus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Visual Acuity at 1 and 3 months after surgery
2. Intraocular pressure at 1 and 3 months after surgery
3. Topography and Corneal thickness at 1 and 3 months after surgery
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Donor stromal cornea prepared by femto-second laser was transplanted into recipient cornea lammelar cut also by femto-seconf laser.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Visual acuity with hard contact lenses < 0.6 or visual acuity with glasses <0.4
2. 250 < the thinnest corneal thickness < 400 micro m
3.Patients decided as necessary of corneal transplantation by attending doctor.
Key exclusion criteria
1. Alkari corneal burn, Stevens-Johnson Syndrome, ocular pemphygoid
2. Severe corneal opacity and/or scar formation
3. Abnormal margin of eye lid inclugding tumor
4. After refractive surgery including LASIK
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Kawakita |
Organization
Minami aoyama eye clinic
Division name
Ophthalmology
Zip code
Address
3-3-11, Kita-aoyama, Minato, Tokyo
TEL
03-5772-1451
kawatetsu@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Kawakita |
Organization
minami aoyama eye clinic
Division name
Ophthalmology
Zip code
Address
3-3-11, Kita-aoyama, Minato, Tokyo
TEL
03-5772-1451
Homepage URL
kawatetsu@gmail.com
Sponsor or person
Institute
Minami aoyama eye clinic
Institute
Department
Personal name
Funding Source
Organization
Self Funding
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
| 2016 | Year | 01 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 17 | Day |
Last modified on
| 2016 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023387
