UMIN-CTR Clinical Trial

Public title

Comprehensive basic research to elucidate the glaucoma pathology

Acronym

Comprehensive basic research to elucidate the glaucoma pathology

Scientific Title

Comprehensive basic research to elucidate the glaucoma pathology

Scientific Title:Acronym

Comprehensive basic research to elucidate the glaucoma pathology

Region

Japan

Condition

glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To reveal the factors of pathogenesis and progression for glaucoma by investigating biologically active substance, protein, metabolite, etc comprehensively.

Basic objectives2

Others

Basic objectives -Others

To reveal the factors related to prognosis for glaucoma surgery by culture experiments using cell lines derived from patients' eye tissue.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[Aqueous humor, blood, Urine]
1.Abundance of nucleic acid, protein, lipid, metabolite, etc
2.Abundance of biologically active substance(cytokine, prostaglandin, endothelin, etc)
3.Abundance of trace metal(Zinc, Mercury, etc)
4.Comprehensively Profile of autoantibody
5.Transcript abundance

[Ocular tissue(sclera, Schlemm's canal, iris, trabecular meshwork)]
1.Abundance of nucleic acid, protein, lipid, metabolite, etc
2.Abundance of biologically active substance(cytokine, prostaglandin, endothelin, etc)
3.Abundance of trace metal(Zinc, Mercury, etc)
4.Comprehensively Profile of autoantibody
5.Transcript abundance
6.Abundance of glycosaminoglycan and glycosaminoglycan-degrading enzyme
7.Evaluating the tissue structure

[Ocular tissue(tenon's fibroblast cells)]
1.Abundance of nucleic acid, protein, lipid, metabolite, etc
2.Abundance of biologically active substance(cytokine, prostaglandin, endothelin, etc)
3.Transcript abundance
4.Evaluating cell formation, cell proliferation and cell contraction

In addition to the above, the relationship beteween above the factor and clinical information(age, sex, visual acuity intraocular pressure, visual field, etc).

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Surgical patients who will undergo glaucoma surgery(trabeculectomy, trabeculotomy, trabecutome, etc) or cataract surgery.

2.Performance Status: 0 ~ 4.
3.Patients who are 20 years of age or more.
4.Patients who understood and signed letter of consent.

Key exclusion criteria

1.Patients undergoing the treatment for malignant tumor.
2.Patients undergoing hemodialysis.
3.Patients with severe systemic disease.
4.Patients who are inadequate for this study on the based on physician's discretion.

Target sample size

500

Name of lead principal investigator

1st name
Middle name
Last name	Yu Yokoyama

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan

TEL

81-22-717-7294

Email

yu-yokoyama@oph.med.tohoku.ac.jp

Name of contact person

1st name
Middle name
Last name	Yu Yokoyama

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan

TEL

81-22-717-7294

Homepage URL

Email

yu-yokoyama@oph.med.tohoku.ac.jp

Institute

Department of Ophthalmology, Tohoku University Graduate School of Medicine

Institute

Department

Personal name

Organization

Santen Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Seikagaku Corporation
Japan Tobacco Inc.

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

08

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Date of protocol fixation

2016

Year

04

Month

25

Day

Date of IRB

Anticipated trial start date

2016

Year

08

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Samples, which is corrected in other two studies approved by IRB of tohoku university, is used in this study based on information disclosure. The two other studies is shown below.
1.Investigation for elucidation of glaucoma pathology and of factors correlated with prognosis of glaucoma surgery.
2.Accompanying research with investigation for elucidation of glaucoma pathology and of factors correlated with prognosis of glaucoma surgery.

Registered date

2016

Year

08

Month

18

Day

Last modified on

2018

Year

05

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026981