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

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 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


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

Value
https://center6.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