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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007516
Receipt No. R000008870
Scientific Title Morphological analysis of myopic change of the optic disc and the retinal nerve fiber in glaucoma, glaucoma suspect, ocular hypertension and healthy eyes
Date of disclosure of the study information 2012/03/19
Last modified on 2015/05/11

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Basic information
Public title Morphological analysis of myopic change of the optic disc and the retinal nerve fiber in glaucoma, glaucoma suspect, ocular hypertension and healthy eyes
Acronym Morphological analysis of myopic change of the optic disc and the retinal nerve fiber in glaucomatous eyes
Scientific Title Morphological analysis of myopic change of the optic disc and the retinal nerve fiber in glaucoma, glaucoma suspect, ocular hypertension and healthy eyes
Scientific Title:Acronym Morphological analysis of myopic change of the optic disc and the retinal nerve fiber in glaucomatous eyes
Region
Japan

Condition
Condition Glaucoma, glaucoma suspect, ocular hypertension and healthy eyes
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the morphological change of the optic disc and the retinal nerve fiber in glaucoma, glaucoma suspect, ocular hypertension and healthy eyes using optical coherence tomography
Basic objectives2 Others
Basic objectives -Others To investigate the relationship between the optic disc (size, ovality, tilt, rotation, conus) or the retinal nerve fiber (trajectory) morphology and axial length in glaucoma, glaucoma suspect, ocular hypertension and healthy eyes.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The relationship between the optic disc (size, ovality, tilt, rotation, conus) or the retinal nerve fiber (trajectory) morphology and axial length in glaucoma, glaucoma suspect, ocular hypertension and healthy eyes.
Key secondary outcomes The relationship between the optic disc (size, ovality, tilt, rotation, conus) or the retinal nerve fiber (trajectory) morphology and spherical equivalent in glaucoma, glaucoma suspect, ocular hypertension and healthy eyes.



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

Not applicable
Gender Male and Female
Key inclusion criteria Glaucoma, glaucoma suspect, ocular hypertension and healthy eye
Key exclusion criteria History of refractive surgery

Active ocular disease, except glaucoma, glaucoma suspect and ocular hypertension

Systemic diseases affecting eyes
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takehiro Yamashita
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Ophthalmology
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima JAPAN
TEL 099-275-5402
Email take1@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takehiro Yamashita
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Ophthalmology
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima JAPAN
TEL 099-275-5111
Homepage URL
Email take1@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Moorfields eye hospital
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 鹿児島大学病院(鹿児島県)
Kagoshima university medical and dental hospital(Kagoshima)

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 19 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 Open public recruiting
Date of protocol fixation
2011 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2012 Year 04 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 Tests
Optical coherence tomography
A-mode ultrasound
B-mode ultrasound
Visual acuity
Intraocular pressure
Fundus image
Refraction
Visual field

Management information
Registered date
2012 Year 03 Month 15 Day
Last modified on
2015 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008870

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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