UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008112 |
|---|---|
| Receipt number | R000009549 |
| Scientific Title | Clinical Results of the Corneal Surgery Using Excimer Laser and Femtosecond Laser |
| Date of disclosure of the study information | 2012/06/21 |
| Last modified on | 2024/12/15 13:55:46 |
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Basic information
Public title
Clinical Results of the Corneal Surgery Using Excimer Laser and Femtosecond Laser
Acronym
Clinical Results of the Laser Corneal Surgery
Scientific Title
Clinical Results of the Corneal Surgery Using Excimer Laser and Femtosecond Laser
Scientific Title:Acronym
Clinical Results of the Laser Corneal Surgery
Region
| Japan |
Condition
Condition
corneal disease, refractive error
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the results of the laser corneal surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
visual acuity
Key secondary outcomes
satisfaction rate of a patient
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
| 1 | years-old | <= |
Age-upper limit
| 110 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The Eyes that were performed Laser Corneal Surgery
Key exclusion criteria
The patients who were followed-up for less than 1 month after the Laser surgery
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Hieda |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
602-0841
Address
465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto , Japan
TEL
075-251-5578
oheida@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Hieda |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
602-0841
Address
465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto , Japan
TEL
075-251-5578
Homepage URL
oheida@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Baptist Eye Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
Kji-cho 465
Tel
0752515578
ohieda@koto.kpu-m.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
| 2012 | Year | 06 | Month | 21 | 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
400
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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
uncorrected visual acuity, corrected visual acuity, patient's satisfaction rate
Management information
Registered date
| 2012 | Year | 06 | Month | 06 | Day |
Last modified on
| 2024 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009549
