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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036817
Receipt No. 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

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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
Email 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
Email ismail.omar@mu.edu.eg

Sponsor
Institute ophthalmology department, faculty of medicine, Minia university.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041943

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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