UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002947 |
|---|---|
| Receipt number | R000002015 |
| Scientific Title | Evaluation of efficacy and safety of riboflavin/UVA treatment for keratoconus/keratectasia |
| Date of disclosure of the study information | 2009/12/28 |
| Last modified on | 2017/07/04 19:43:50 |
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Basic information
Public title
Evaluation of efficacy and safety of riboflavin/UVA treatment for keratoconus/keratectasia
Acronym
efficacy and safety of riboflavin/UVA for keratoconus
Scientific Title
Evaluation of efficacy and safety of riboflavin/UVA treatment for keratoconus/keratectasia
Scientific Title:Acronym
efficacy and safety of riboflavin/UVA for keratoconus
Region
| Japan |
Condition
Condition
Keratoconus, keratectasia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess efficacy and safety of riboflavin/UVA treatment on the cornea with keratoconus/keratectasia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity, refraction, corneal curvature, corneal topography, corneal endothelial cell counts, and incidence of complications
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Collagen fibers of the corneal stroma will be crosslinked by the combination of instillation of riboflavin solution and ultraviolet-A irradiation for 30 minutes after corneal epithelial debridement.
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
| 14 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Keratoconus or keratectasia
2. The most thinnest corneal thickness more than 400 micrometer
3. In cases with keratoconus, progression should be observed within recent 6 months. In cases with keratectasia, protrusion of the cornea should be progressed after the previous corneal refractive surgeries.
Key exclusion criteria
1. The corneal thickness less than 400 micrometer
2. Those who implanted medical instruments, such as pacemaker.
3. Ocular diseases, such as infection, corneal scar, herpetic keratitis, and/or nystagmus
4. Systemic diseases affecting corneal would healing
5. Eyes with narrow angle. Pregnant or breast-feeding women.
6. Occupation, by which refractive surgery is not arrowed
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Tsubota |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
03-3353-1211
keio.eye.research.sec@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko Kato |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology, Refractive Surgery Clinic
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
nkato@ndmc.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2009 | Year | 12 | Month | 28 | 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
| 2008 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 28 | Day |
Last modified on
| 2017 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002015
