UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000437 |
|---|---|
| Receipt number | R000000531 |
| Scientific Title | The comparison of the results of trabeculectomy and phacotrabeculectomy in eyes with open-angle glaucoma. |
| Date of disclosure of the study information | 2006/07/01 |
| Last modified on | 2011/01/18 14:53:08 |
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Basic information
Public title
The comparison of the results of trabeculectomy and phacotrabeculectomy in eyes with open-angle glaucoma.
Acronym
Trabeculectomy vs phacotrabeculectomy in open-angle glaucoma.
Scientific Title
The comparison of the results of trabeculectomy and phacotrabeculectomy in eyes with open-angle glaucoma.
Scientific Title:Acronym
Trabeculectomy vs phacotrabeculectomy in open-angle glaucoma.
Region
| Japan |
Condition
Condition
Primary open-angle glaucoma and exfoliation glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and the effect of trabeculectomy and phacotrabeculectomy for open-angle glaucoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative intraocular pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Trabeculectomy
Interventions/Control_2
Phacotrabeculectomy
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Either primary open-angle glaucoma or exfoliation glaucoma patients, associated with cataract, who experienced the intraocular pressure of 22 mmHg or higher at least two times within recent 3 months with two or more antiglaucomatous ophthalmic solutions.
2.Written informed consent from the patient.
Key exclusion criteria
1.The patients who have been treated with intraocular surgeries.
2.Judged inappropriate for this study by physicians.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Inatani |
Organization
Kumamoto University Graduate School of Medical Sciencies
Division name
Department of Opthalmology and Visual Science
Zip code
Address
1-1-1 Honjo Kumamoto,860-8556
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kumamoto University Graduate School of Medical Sciencies
Division name
Department of Opthalmology and Visual Science
Zip code
Address
TEL
Homepage URL
inatani@fc.kuh.kumaomoto-u.ac.jp
Sponsor or person
Institute
Department of Opthalmology and Visual Science,Kumamoto University Graduate School of Medical Sciencies
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
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
| 2006 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2006 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 06 | Month | 26 | Day |
Last modified on
| 2011 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000531
