UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032348 |
|---|---|
| Receipt number | R000036895 |
| Scientific Title | Outcomes of Phototherapeutic Keratectomy Using Anti CI program. |
| Date of disclosure of the study information | 2018/04/23 |
| Last modified on | 2018/04/23 18:42:52 |
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Basic information
Public title
Outcomes of Phototherapeutic Keratectomy Using Anti CI program.
Acronym
Outcomes of Phototherapeutic Keratectomy Using Photorefractive Keratectomy Mode.
Scientific Title
Outcomes of Phototherapeutic Keratectomy Using Anti CI program.
Scientific Title:Acronym
Outcomes of Phototherapeutic Keratectomy Using Photorefractive Keratectomy Mode.
Region
| Japan |
Condition
Condition
band keratopathy and granular corneal dystrophy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the outcomes of phototherapeutic keratectomy (PTK) using anti-central island (CI) program and to compare visual acuity and the rate of CI after PTK with and without CI program.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative Visial acurity
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
| 38 | years-old | <= |
Age-upper limit
| 92 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who had PTK for corneal degeneration at Kitasato University Hospital
Key exclusion criteria
Patients with other corneal diseases, active uveitis, glaucoma, ocular floor disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutaka Kamiya |
Organization
Kitasato University Hospital
Division name
Ophthalmology
Zip code
Address
1-15-1 Kitasato Minami-ku Sagamihara-shi
TEL
0427788111
ads00133@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahide Takahashi |
Organization
Kitasato University Hospital
Division name
Ophthalmology
Zip code
Address
1-15-1 Kitasato Minami-ku Sagamihara-shi
TEL
0427788111
Homepage URL
zavide96@gmail.com
Sponsor or person
Institute
Kitasato University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitasato University Hospital
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
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
| 2018 | Year | 04 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2018 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The use of the anti-CI program for PTK with the VISX Star S4 excimer laser system significantly decrease the rate of CI formation, in association with the improvement of visual acuity.
Management information
Registered date
| 2018 | Year | 04 | Month | 23 | Day |
Last modified on
| 2018 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036895
