UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007516 |
|---|---|
| Receipt number | 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 08:31:29 |
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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
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
take1@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008870
