UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036108 |
|---|---|
| Receipt number | R000041133 |
| Scientific Title | Quantitative analysis of effect on corneal epithelial recovery and visual quality using platelet-rich plasma for corneal erosion. |
| Date of disclosure of the study information | 2019/03/06 |
| Last modified on | 2020/03/06 09:49:30 |
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Basic information
Public title
Quantitative analysis of effect on corneal epithelial recovery and visual quality using platelet-rich plasma for corneal erosion.
Acronym
corneal epithelial recovery and visual quality using platelet-rich plasma for corneal erosion
Scientific Title
Quantitative analysis of effect on corneal epithelial recovery and visual quality using platelet-rich plasma for corneal erosion.
Scientific Title:Acronym
corneal epithelial recovery and visual quality using platelet-rich plasma for corneal erosion
Region
| Japan |
Condition
Condition
Corneal erosion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of PRP treatment for corneal erosion after PTK
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area of corneal erosion
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
Candidates for phototherapeutic keratectomy in eyes with granular corneal dystrophy and band keratopathy.
Key exclusion criteria
Eyes with other ophthalmic diseases such as keratoconus.
Target sample size
10
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 Science
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 Science
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
| 2019 | Year | 03 | Month | 06 | 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
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Time points
Before PTK, 1,3,5,7 days and 1 month after PTK
Measurement Outcomes
Visual acuity
Refraction
Area of corneal erosion
Score of staining for corneal and conjunctival epithelium
Questionnaire of subjective symptoms
Patient Satisfaction
Corneal topography
Complications
Management information
Registered date
| 2019 | Year | 03 | Month | 06 | Day |
Last modified on
| 2020 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041133
