UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026674 |
|---|---|
| Receipt number | R000030630 |
| Scientific Title | Efficacy of femtosecond-assisted keratoplasty |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2018/09/14 10:36:23 |
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Basic information
Public title
Efficacy of femtosecond-assisted keratoplasty
Acronym
Femtosecond-assisted keratoplasty
Scientific Title
Efficacy of femtosecond-assisted keratoplasty
Scientific Title:Acronym
Femtosecond-assisted keratoplasty
Region
| Japan |
Condition
Condition
Corneal diseases, such as corneal opacity, keratoconus, bullous keratoplasty, etc.
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of femtosecond laser-assisted keratoplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity, intraocular pressure, corneal tomography, corneal endothelial cell density, complications.
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Femtosecond laser-assisted keratoplasty
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Those who have corneal diseases that are indicated for keratoplasty, such as corneal opacity, keratoconus, or bullous keratopathy.
2. Age 20 year-old, or more.
3. No sign of other ocular diseases, such as active uveitis, glaucoma, etc.
4. No history of general diseases that could affect the wound healing, such as diabetes mellitus.
5. Those who can provide informed consent.
Key exclusion criteria
1. Those who have dense corneal opacity that interfere laser incision.
2. Age 19 year-old or less.
3. Signs of other ocular diseases, such as active uveitis. glaucoma, etc.
4. History of general diseases that could affect the would healing, such as diabetes mellitus.
5. Those who have no capacity to provide informed consent.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoko Kato |
Organization
Saitama Medical University
Division name
Department of Ophthalmology
Zip code
Address
Morohongo 38, Iruma, Saitama
TEL
049-276-1250
naokato@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko Kato |
Organization
Saitama Medical University
Division name
Department of Ophthalmology
Zip code
Address
Morohongo 38, Iruma, Saitama
TEL
049-276-1250
Homepage URL
naokato@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
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
| 2017 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 04 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | 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
| 2017 | Year | 03 | Month | 23 | Day |
Last modified on
| 2018 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030630
