UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective Study of Glaucoma Surgery(Kyoto University Glaucoma Surgery Study)
Title of the study (Brief title)	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	Nagahisa Yoshimura
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Ophthalmology and Visual Sciences
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	Tadamichi Akagi
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Ophthalmology and Visual Sciences
Address	54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto
TEL	075-751-3250
Homepage URL
Email	akagi@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018054