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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005299
Receipt No. 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

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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
Email

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
Email yama19770614@hotmail.com

Sponsor
Institute Tokyo Dental College
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006303

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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