UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015542
Receipt number R000018054
Scientific Title Prospective Study of Glaucoma Surgery(Kyoto University Glaucoma Surgery Study)
Date of disclosure of the study information 2014/10/31
Last modified on 2018/03/01 14:52:04

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Basic information

Public title

Prospective Study of Glaucoma Surgery(Kyoto University Glaucoma Surgery Study)

Acronym

Glaucoma Surgery Study

Scientific Title

Prospective Study of Glaucoma Surgery(Kyoto University Glaucoma Surgery Study)

Scientific Title:Acronym

Glaucoma Surgery Study

Region

Japan


Condition

Condition

Glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To track postoperative results and investigate influencing factors in several types of glaucoma surgery

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

intraocular pressure, adverse event

Key secondary outcomes

visual acuity, visual field, optical coherence tomography, corneal endothelial cells,


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


 Not applicable

Age-upper limit


 Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who require glaucoma surgery

Key exclusion criteria

Patients who does not agree with the informed-consent

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nagahisa Yoshimura

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Ophthalmology and Visual Sciences

Zip code


Address

54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto

TEL

075-751-3248

Email

nagaeye@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tadamichi Akagi

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Ophthalmology and Visual Sciences

Zip code


Address

54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto

TEL

075-751-3250

Homepage URL


Email

akagi@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Trust Accounts (Scholarship Contributions)

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 31 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Mean preoperative IOPs were 22.6+-7.4 mmHg in the TAT group and 24.3+-6.6 mmHg in the TLO group. Mean postoperative IOPs in the TAT group were 15.8 +- 3.6 mmHg at 12-months, and 15.7+-5.5 mmHg at 36-months, and 16.0+-3.4 mmHg at 12 months and 15.2+-3.8 mmHg at 36 months in the TLO group. Postoperatively, success rates at 36-months were significantly higher in the TLO group in some criteria; IOP reductions at 1- and 2- years were significantly higher in the TLO group; these differences were not significant after adjustment with other potential prognostic factors. The number of glaucoma medications were significantly higher in the TAT group, at 2-years (P < 0.001) but not at 3-years (P = 0.22).
Surgical successes following TLO and TAT are not significantly different 3 years postoperatively after adjustment of potential prognostic factors.

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

Completed

Date of protocol fixation

2014 Year 10 Month 31 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 04 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective observational study


Management information

Registered date

2014 Year 10 Month 27 Day

Last modified on

2018 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018054


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name