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
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
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
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
