UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031030 |
|---|---|
| Receipt number | R000035439 |
| Scientific Title | Comparison of Visual Performance in Eyes Undergoing Femtosecond Laser-Assisted Keratoplasty for Advanced Keratoconus and Eyes with Keratoconus. |
| Date of disclosure of the study information | 2018/01/28 |
| Last modified on | 2019/08/23 22:32:09 |
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Basic information
Public title
Comparison of Visual Performance in Eyes Undergoing Femtosecond Laser-Assisted Keratoplasty for Advanced Keratoconus and Eyes with Keratoconus.
Acronym
Visual performance after femtosecond laser-assisted keratoplasty for keratoconus.
Scientific Title
Comparison of Visual Performance in Eyes Undergoing Femtosecond Laser-Assisted Keratoplasty for Advanced Keratoconus and Eyes with Keratoconus.
Scientific Title:Acronym
Visual performance after femtosecond laser-assisted keratoplasty for keratoconus.
Region
| Japan |
Condition
Condition
keratoconus
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare visual performance in eyes having femtosecond laser-assisted keratoplasty (FLAK) for keratoconus and keratoconic eyes according to the Amsler-Krumeich classification.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
best spectacle-corrected visual acuity (BSCVA), corneal astigmatism, corneal densitometry, and corneal higher-order aberrations (HOAs)
Key secondary outcomes
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
keratoconic eyes undergoing femtosecond laser-assisted penetrating keratoplasty.
Key exclusion criteria
eyes with other corneal diseases, and previous ocular trauma or surgery
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazutaka |
| Middle name | |
| Last name | Kamiya |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
2520373
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL
0427788464
kamiyak-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kazutaka |
| Middle name | |
| Last name | Kamiya |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
2520373
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL
0427788464
Homepage URL
kamiyak-tky@umin.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
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
Kitasato University
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
Tel
0427788464
kamiyak-tky@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 | 01 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 01 | Month | 28 | Day |
Last modified on
| 2019 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035439
