UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044107 |
|---|---|
| Receipt number | R000050356 |
| Scientific Title | Comparison of Visual and Refractive Outcomes of Hyperopia Correcting-PTK and Conventional PTK |
| Date of disclosure of the study information | 2021/05/08 |
| Last modified on | 2023/05/07 12:47:50 |
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Basic information
Public title
Comparison of Visual and Refractive Outcomes of Hyperopia Correcting-PTK and Conventional PTK
Acronym
Comparison of Hyperopia Correcting-PTK and Conventional PTK
Scientific Title
Comparison of Visual and Refractive Outcomes of Hyperopia Correcting-PTK and Conventional PTK
Scientific Title:Acronym
Comparison of Hyperopia Correcting-PTK and Conventional PTK
Region
| Japan |
Condition
Condition
corneal dystrophy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
compare HC-PTK and conventional PTK
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
refraction
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We retrospectively evaluated patients who underwent HC-PTK and conventional PTK for granular corneal dystrophy or band keratopathy.
Key exclusion criteria
none
Target sample size
69
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
2520375
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL
042-778-8111
kamiyak-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Hayakawa |
Organization
Kitasato University
Division name
school of medicine
Zip code
2520375
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL
042-778-8111
Homepage URL
m09088w@st.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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 Hospital
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
Tel
042-778-8273
rinrib@med.kitasato-u.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
| 2021 | Year | 05 | Month | 08 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35355603/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35355603/
Number of participants that the trial has enrolled
49
Results
https://pubmed.ncbi.nlm.nih.gov/35355603/
Results date posted
| 2023 | Year | 05 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://pubmed.ncbi.nlm.nih.gov/35355603/
Participant flow
https://pubmed.ncbi.nlm.nih.gov/35355603/
Adverse events
none
Outcome measures
https://pubmed.ncbi.nlm.nih.gov/35355603/
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 11 | Month | 01 | Day |
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 05 | Month | 05 | Day |
Last modified on
| 2023 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050356
