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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002947
Receipt No. 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

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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
Email 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
Email nkato@ndmc.ac.jp

Sponsor
Institute Department of Ophthalmology, Keio University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002015

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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