UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005299 |
|---|---|
| Receipt number | R000006303 |
| Scientific Title | Influence of Disruption of Physiological Parallelism of Corneal Anterior and Posterior Surfaces on Aberrations in Eyes after Keratoplasty |
| Date of disclosure of the study information | 2011/03/24 |
| Last modified on | 2011/03/24 02:45:15 |
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Basic information
Public title
Influence of Disruption of Physiological Parallelism of Corneal Anterior and Posterior Surfaces on Aberrations in Eyes after Keratoplasty
Acronym
Influence of Disruption of Physiological Parallelism of Corneal Anterior and Posterior Surfaces on Aberrations in Eyes after Keratoplasty
Scientific Title
Influence of Disruption of Physiological Parallelism of Corneal Anterior and Posterior Surfaces on Aberrations in Eyes after Keratoplasty
Scientific Title:Acronym
Influence of Disruption of Physiological Parallelism of Corneal Anterior and Posterior Surfaces on Aberrations in Eyes after Keratoplasty
Region
| Japan |
Condition
Condition
Normal eyes, eyes after keratoplasty
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of disruption of parallelism of anterior and posterior corneal surfaces on higher-order aberrations of the cornea and visual acuity after keratoplasty.
Basic objectives2
Others
Basic objectives -Others
By using ray tracing in combination with anteror segment optical coherence tomography, we calculated total corneal aberration.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual acuity, Wavefront aberration, Surface parallelism index
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Normal eyes and eyes after keratoplasty
Key exclusion criteria
The exclusion criteria included corneal scar or opacity in the graft, persistent epithelial defect, severe dry eye or ocular cicatrical diseases, graft rejection, ptyergium, previous glaucoma surgery and retinal diseases.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamaguchi Takefumi |
Organization
Tokyo Dental College
Division name
Ophthalmology
Zip code
Address
5-11-13, Sugano, Ichikawa, Chiba, Japan
TEL
047-322-0151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamaguchi Takefumi |
Organization
Tokyo Dental Collge
Division name
ophthalmology
Zip code
Address
TEL
Homepage URL
yama19770614@hotmail.com
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
2010-2011 Grant-in-Aid for Scientific Research No. 20383771
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
東京歯科大学市川総合病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Corneal topography of anterior and posterior surfaces and pachymetry were conducted using anterior segment optical coherence tomography. Anterior, posterior, and total corneal aberration were calculated using ray tracing and decomposition into Zernike polynomials and were evaluated as root-mean-square values. Modulation transfer functions were also evaluated.
Management information
Registered date
| 2011 | Year | 03 | Month | 24 | Day |
Last modified on
| 2011 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006303
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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