UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036817 |
|---|---|
| Receipt number | R000041943 |
| Scientific Title | Accelerated epithelium-off corneal collagen cross linking for keratoconus: 12 months results |
| Date of disclosure of the study information | 2019/05/22 |
| Last modified on | 2019/05/22 05:24:36 |
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Basic information
Public title
Accelerated epithelium-off corneal collagen cross linking for keratoconus: 12 months results
Acronym
Accelerated epithelium-off corneal collagen cross linking for keratoconus: 12 months results
Scientific Title
Accelerated epithelium-off corneal collagen cross linking for keratoconus: 12 months results
Scientific Title:Acronym
Accelerated epithelium-off corneal collagen cross linking for keratoconus: 12 months results
Region
| Africa |
Condition
Condition
keratoconus
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the outcome of corneal cross linking on keratoconic eyes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
stability of corneal condition
Key secondary outcomes
higher order aberrations changes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Accelerated cornel collagen cross linking
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
keratoconus
Key exclusion criteria
corneal opacity and previous surgery
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | ismail |
| Middle name | |
| Last name | omar |
Organization
Minia university hospital
Division name
minia university
Zip code
61111
Address
kornish el-nile
TEL
+20102554116
ismail.omar@mu.edu.eg
Public contact
Name of contact person
| 1st name | ismail |
| Middle name | |
| Last name | omar |
Organization
Minia university hospital
Division name
Minia university
Zip code
61111
Address
kornish el-nile
TEL
+201002554116
Homepage URL
ismail.omar@mu.edu.eg
Sponsor or person
Institute
ophthalmology department, faculty of medicine, Minia university.
Institute
Department
Personal name
Funding Source
Organization
self
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
faculty of medicine, minia university
Address
El-minia, Egypt
Tel
+20862347460
med.prt@mu.edu.eg
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 | 05 | Month | 22 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
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
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | 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
| 2019 | Year | 05 | Month | 22 | Day |
Last modified on
| 2019 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041943
